435 submissions from 317 organizations told the European Commission what they think about this file. Here is what each of them said, in their own words.
The Commission lists 1,096 submissions on this file. Shown here: the 435 from organizations. Not shown, by design: submissions from private individuals, which we never publish, and anything filed since our last weekly refresh.
CommitteeSANTRapporteurPernille Weiss-ehler (EPP)
Approval of the provisional agreement with the Council by the EP committee responsible · 18 Mar 2026
Committee Approved the Provisional Agreement · 18 Mar 2026
Endorsement of the provisional agreement by Coreper · 6 Mar 2026
Deliberations in Coreper · 19 Dec 2025
INTERINSTITUTIONAL_NEGOTIATION · 10 Dec 2025
Who showed up
227 submissions from industry — companies and their trade associations — against 125 from civil society: NGOs, consumer organizations, environmental groups and trade unions. That is 1.8 industry submissions for every one from civil society.
Industry 227Civil society 125Public authorities, academia, other 83
Groupings use the respondent type each organization selected when filing. Counting submissions, not organizations — a body that filed twice is counted twice.
What the room declares
154 of 317
in the EU Register
550
full-time lobbying staff
€80.0M+
declared costs a year
371
EP accreditations declared
Self-declared to the EU Transparency Register (snapshot 2 Sept 2026). The cost figure sums band floors, so the true total is higher.
The file, right now
The consultation closed on 8 Nov 2023 — it ran from 26 Apr 2023.
One block of text on this file was submitted, identically, by three or more organizations. Shared text is a fact about the filings; what it means is for the reader.
12 organizations: Arztpraxis, DTZ Berlin, Georg-August-University Göttingen, Heart and Diabetes Center - University Hospital Bochum - Radiopharmacy, Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Nuklearmedizin Neumann MVZ, Nuklearmedizinische Praxis, PET e.V., Schwarzwald-Baar-Klinikum, University hospital, University Hospital Münster, Zuhayra, Maaz, Prof. Dr., Radiopharmacist, Nucleare Medicine UKSH, Campus Kiel
“The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.”
Showing 25 of 250 submissions on this page · page 1 of 2 · 435 across the file. Search the whole file
Fundacja SMA welcomes the reform of the EU pharmaceutical legislation, seeing many of the proposed changes as an ambitious tool that will improve the development of, and access to, treatments for rare disorders. That said, wed like to share a few comments (see attached document).
The Trade Association has seen the European Commission’s objectives under the Pharmaceutical Strategy as an opportunity to strengthen the pharmaceutical base in Austria and Europe and continues to support them. The present proposal to implement this strategy does not meet these objectives.
Filed in German · English published by the European Commission
We appreciate the Commissions efforts to incentivise drug repurposing. We firmly believe that, in addition to pull incentives, the European Medicines Facility (EMF) should also work on generic drug repurposing to foster innovation and potentially unlock untapped, cost-effective therapies. We strongly urge the Parliament to reassess article 40a of the Regulation per our proposed amendments attached.
Eckert & Ziegler Radiopharma GmbH, a company located with its headquarter in Berlin, Germany, is the radiopharmaceutical division of the Eckert & Ziegler Group - a leading provider of radioisotope products for medical, scientific and industrial applications.
Fondazione Telethon (Italy) is an Italian non-profit organization that has been supporting bio-medical research on rare and genetic diseases for more than 30 years. Since 2023 it has become the first not-for profit marketing authorization holder of an ATMP for a ultra-rare disease in the EU.
Our association seeks to protect the patient from the many fake therapies that can actively harm their health, delay or abandon scientifically endorsed treatment, or pay substantially for them. We believe that the measures proposed in the draft will bring about significant improvements in the research and technology of medicines, their efficacy and their safety, and thus the protection of patients.
Filed in Spanish · English published by the European Commission
The WHO Global Oral Health Status Report (2022) estimated that oral diseases, affect close to 3.5 billion people worldwide. The European Region has the highest prevalence of all. Toothpaste is on the WHO essential medicines list with other oral healthcare products also being considered. Ensuring ease of access to such preventive products is key in the fight against the rising prevalence of oral diseases.
As a company involved in the EU in the development of microbiome-based products for human health, we welcome the proposal for a new Directive as it is a step towards recognizing microbiome-based medicinal products by defining SoHO-derived medicinal product other than ATMPs (hereinafter abbreviated SoHO-DMP), which will include microbiome-based medicinal products produced from human microbiomes.
1) Waivers during a public health emergency: There is a severe inconsistency in the Regulation as in Preamble (155) is stated that: This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and notably human dignity, . the rights of the child..
BIO supports the EUs objectives of increasing access to medicines and fostering innovation. We welcome the EUs efforts to enhance the regulatory environment, including the use of expedited pathways, streamlining regulatory decision-making processes, and reducing administrative burdens.
Motol University Hospital (MUH) is one of the most important European centers providing comprehensive health care. The mission of MUH is to treat the sick on the basis of current knowledge of medical science and to provide its clients with comprehensive and high-quality highly specialized care for all phases of human life.
The New EU Pharmaceuticals law is a very important legislation for the future of healthcare in the European Union and Nuclear Medicine Europe (NMEU) would like to draw your attention to some specific aspects that touch on the field of Nuclear Medicine. NMEU represents the majority of the pharmaceutical & imaging equipment companies in the field of Nuclear Medicine.
Thank you for the opportunity to provide feedback on the proposed revisions to the EU general pharmaceuticals legislation. Cruelty Free Europe welcomes the provisions that support a shift away from testing on animals and towards greater use of non-animal methods this would advance many of the goals of the revision including addressing unmet medical needs, improving competitiveness, fostering innovation, improving…
Thank you for the opportunity to provide feedback on the proposed revisions to the EU general pharmaceuticals legislation. Cruelty Free Europe welcomes the provisions that support a shift away from testing on animals and towards greater use of non-animal methods this would advance many of the goals of the revision including addressing unmet medical needs, improving competitiveness, fostering innovation, improving…
Since it was not possible to preview the attached file I also include the feedback from EIPG here: EIPG POSITION PAPER ON THE REVISED EUROPEAN PHARMACEUTICAL LEGISLATION The European Industrial Pharmacists Group (EIPG) is a European association representing the national, and professional organisations of pharmacists employed in the pharmaceutical or allied industries of the Member States of the European Union, the…
The European Cancer Organisation is an umbrella federation of 41 European and international level societies working with 21 patient advocacy organisations to improve cancer care and outcomes in all countries. Pharmaceutical treatment is one of the mainstay treatment modalities in cancer care, and a field in which great progress has been achieved over many decades, making important contribution towards improved…
Off-patent drug repurposing has a massive but untapped potential due to a lack of financial incentives. We, a collective of NGOs, academics, and startups, appreciate the Commission's efforts to incentivise drug repurposing in Article 84 of the proposed Directive. However, the proposed 4-year data protection period for repurposed drugs is unfortunately insufficient.
Humane Society International/Europe (HSI) welcomes the European Commissions proposal to revise and modernise the EU general legislation on medicines for human use. As an animal protection organisation, we support the Pharmaceutical Strategy for Europe as a great opportunity to leverage new technologies to better address patients needs while reducing the use of live animals in the sector.
The Radiopharmaceutical Section of the Czech Society of Nuclear Medicine together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
Humane Society International/Europe (HSI) welcomes the European Commissions proposal to revise and modernise the EU general legislation on medicines for human use. As an animal protection organisation, we support the Pharmaceutical Strategy for Europe as a great opportunity to leverage new technologies to better address patients needs while reducing the use of live animals in the sector.
Moderna, with its mission to deliver the greatest possible impact to people through mRNA medicines, welcomes the overall objectives of the revision of the General Pharma Legislation (GPL) as proposed by the Commission to create an innovative and competitive EU healthcare ecosystem, to invest in R&D, and to provide early innovative medicines to patients.
Commissions proposal is the start of the discussion for a balanced package. It is an opportunity to enhance Europe's attractiveness for research, development, and production of medicines. APIFARMA would like to contribute to this public consultation based on some of its specific points of view.
Access to affordable treatments for rare diseases remain a challenge in eye diseases.We applaud the European Commission's support to the retention & strengthening of Hospital Exemption (HE) as it contributes in reducing the current misalignment between public health priorities & industry outputs particularly in diseases with no commercial interest to industry.However its uneven implementation contributes to…
Lymphoma Coalition response on the Pharmaceutical Legislation Consultation Lymphoma Coalition (LC) is a global network of patient organisations focused on providing support to those affected by lymphoma, including chronic lymphocytic leukaemia (CLL) for over two decades.
Moderna, with its mission to deliver the greatest possible impact to people through mRNA medicines, welcomes the overall objectives of the revision of the General Pharma Legislation (GPL) as proposed by the Commission to create an innovative and competitive EU healthcare ecosystem, to invest in R&D, and to provide early innovative medicines to patients.
IPFA appreciates the intent of the Proposal to - harmonise the rights and obligations of the competent authorities of the MS of Europe, both for supervision and for regulatory requirements; and to simplify regulatory practices; - aim for fair access to medicines for all patients in Europe by strengthening security of supply; - enhance environmental protection throughout the life of the medicinal product; - increase…
Neurofibromatosis Patients United (NFPU) serves as the preeminent umbrella association for patient organizations that work for neurofibromatosis patients within the European region. Neurofibromatosis patients throughout Europe confront remarkably uniform challenges, including constrained access to adequate medical and psychosocial care, limited information resources, restricted availability of clinical trials…
The International Council on Animal Protection in Pharmaceutical Programs (ICAPPP) welcomes the opportunity to provide feedback on the revision of the EU general pharmaceuticals legislation for human use. ICAPPP works to foster innovation in non-animal methods and thereby adapt to scientific and technological developments, e.g., by 'future proofing' legislations.
Neurofibromatosis Patients United (NFPU) serves as the preeminent umbrella association for patient organizations that work for neurofibromatosis patients within the European region. Neurofibromatosis patients throughout Europe confront remarkably uniform challenges, including constrained access to adequate medical and psychosocial care, limited information resources, restricted availability of clinical trials…
The European Health Managements Association (EHMA), EPACT Alliance urges the European Commission and the European Parliament to seize the opportunity to strengthen hospitals pharmaceutical management pathways for 1. The welling being of patients and staff. 2. The availability, accessibility, and safety of medication in hospitals. 3.
Clairvoyant Therapeutics Inc. (Clairvoyant) is grateful for the opportunity to provide its perspective from the field of classical psychedelics on the proposed reform of EU pharmaceutical legislation. In particular we wish to address the risks that will result from the proposed reduction in Regulatory Data Protection (RDP) set forth in Chapter VII.
The PHARMIG with the support of FOPI and ÖVIH – welcomes the European Commission’s objectives. The revision is an opportunity to strengthen Europe as a pharmaceutical site. Nevertheless, some of the proposed measures imply legal uncertainty for businesses and diametrically counter the stated objectives of improving patient access to medicines, fostering innovation and international competitiveness.
Filed in German · English published by the European Commission
The PHARMIG with the support of FOPI and ÖVIH – welcomes the European Commission’s objectives. The revision is an opportunity to strengthen Europe as a pharmaceutical site. Nevertheless, some of the proposed measures imply legal uncertainty for businesses and diametrically counter the stated objectives of improving patient access to medicines, fostering innovation and international competitiveness.
Filed in German · English published by the European Commission
ARPIM supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
ARPIM supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
EPODIN represents an important patient community in Europe suffering of life-threatening neurological conditions, and which rely on adequate access to lifesaving plasma-derived medicinal products (PDMPs). 1.EPODIN welcomes the proposed EU Pharma Regulation with its focus on tackling and preventing medicines shortages.
Eurogroup for Animals welcomes the opportunity to comment on the revision of the EU general pharmaceuticals legislation for human use, offering its full support to measures which will ensure access to affordable and effective medicines for all. Our submission joins the efforts and aligns strongly with ICAPPP, including also some individual comments and recommendations.
EPODIN represents an important patient community in Europe suffering of severely life-threatening neurological medical conditions. EPODIN welcomes the Commission proposal for a separate EU Pharma Directive and strongly supports the overall objective to harmonise the rules governing pharmaceuticals to ensure better access to medicines for EU patients.
Unicancer, the French hospital federation of comprehensive cancer centers, expresses its gratitude to the European Commission for the opportunity to provide feedback in the public consultation on the legislative proposal for revising the EUs legislation on pharmaceuticals. While we welcome the proposal, we have five specific comments which we have integrated in the attached contribution: 1.
Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries. In 2020 Teva saved the healthcare systems more than 8.4 billion EUR across 9 European countries in which we support more than 105,000 jobs.
Deutsche Stiftung Weltbevölkerung's (DSW) main feedback is as follows: 1. The EU pharmaceutical legislation should consider its potential impacts on global health, and explore ways to directly contribute to addressing the most urgent and complex global health challenges.
Teva is a strategic partner of EU healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries. In 2020 Teva saved the healthcare systems more than 8.4 billion EUR across 9 European countries in which we support more than 105,000 jobs.
Madrid, 8 November 2023 POSICIONAMIENTO DE cariotype MH5, S.L. ANTE THE PROPOSAL FOR A REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use, laying down the rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No…
Filed in Spanish · English published by the European Commission
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We bring together 45 national associations from 26 countries.
The European Federation of Allergy and Airways Diseases Patients Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. We bring together 45 national associations from 26 countries.
The European Commission proposal for a revised EUs pharmaceutical legislation is a step in the right direction as it includes recommendations from BEUC on ways to improve access to medicines in Europe. We strongly support measures to increase transparency on public funding for biomedical research, facilitate the development of medicines by non-profit entities, and enhance EU cooperation and action in the prevention…
The BioMed Alliance (representing 36 medical societies) welcomes the objectives that the European Commission set for the revision of the EU pharmaceutical legislation. We recognise that there are persisting issues including problems with the access, the affordability, and the availability of medicines.
The Center for Reproductive Rights welcomes the revision of the EUs regulatory framework on medicinal products, which aims to ensure equal access to affordable medicines and address shortages of supply. The new Directive offers an important opportunity to modernise EU law on medicinal products to take account of significant legal reforms across EU member states to remove bans and restrictions on abortion and expand…
The European Hematology Association (EHA) is the leading representative of hematology and hematology professionals in Europe. A not-for-profit, public-benefit organization with nearly 7,000 members, EHA supports career development and research, develops and harmonizes hematology education, and advocates for enhanced, affordable and equitable access to innovative therapies for patients with hematological disease…
The labeling of the primary packaging (vial) of radiopharmaceuticals is a practice that involves investigative procedures for the manufacturer, with onerous repercussions (procedural and structural). We know that for radiation protection issues, the vial containing radiopharmaceutical cannot be handled so the label on the vial cannot be read by practitioners in Nuclear Medicine, at least as long as it is…
The European Hematology Association (EHA) is the leading representative of hematology and hematology professionals in Europe. A not-for-profit, public-benefit organization with nearly 7,000 members, EHA supports career development and research, develops and harmonizes hematology education, and advocates for enhanced, affordable and equitable access to innovative therapies for patients with hematological disease…
1. Unmet Medical Needs (UMN) and High Unmet Medical Needs (high UMN): We argue that investment in novel medicines overall reduces the financial burden of governments. New drugs that bear lower toxicity levels would reduce long term side effects of paediatric cancer patients and enable them to be productive members of society later in life.
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
EU pharmaceutical law: respect the users view Whereas: The proposed new legislation continues a legal obligation for the package leaflet, and other information to be supplied with medicines, to reflect the results of consultations with target patient groups.
We welcome the European Commission’s proposal for the reform of the EU pharmaceutical legislation. Spanish pharmacists consider that the proposal includes important provisions to improve the supply of medicines in order to meet patients’ needs.
Filed in Spanish · English published by the European Commission
Introduction The Alliance Promotion Microbiote (APM) is an independent non-profit organization gathering more than 20 key players from microbiome public and private sectors (biotech companies, CDMO, public research institutes and clusters, investment funds etc.) with the objective to contribute to a favorable environment to develop microbiome promising sector.
Response to the consultation on the revision of general EU pharmaceutical legislation The European Commission’s legislative proposals are presented as an attempt to address a number of pharmaceutical policy challenges, including: strengthening the security of supply of medicines and tackling shortages; availability of medicines in all EU Member States; combating antimicrobial resistance; the development of medicines…
Filed in French · English published by the European Commission
As an established pharmaceutical company engaged in diagnostic radiopharmaceuticals, ROTOP welcomes the revision of the EC Pharma legislation. In view of the recent advances in the field of theranostics and the technical developments of the last 20 years, we consider it inevitable to adapt the legislation to the new requirements and challenges of nuclear medicine and radiopharmaceutical practice.
The Association of Innovative Pharmaceutical Industry (AIFP) groups together 35 innovative pharmaceutical companies in the Czech Republic that are able to develop and market new, more effective and safer drugs and thus play a key role in the field of drug R&D.
The Portuguese Society of Nuclear Medicine (SPMN) together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous development, especially in the last two decades.
Roche supports EFPIAs response to this consultation. Deeply rooted in Europe, Roche is concerned that the future legislation, if adopted as is, will have a detrimental impact on access to innovation for EU patients and will exacerbate innovation and competitiveness gaps between the EU and other regions of the world.
Dear Sir/Madam, The Dutch Society of Nuclear Medicine together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous development, especially in the last two decades.
The Rare Diseases Working Group hosted by the Fondation de France, composed of French foundations working in the field of rare diseases, thanks the European Commission for this proposal to revise the European Union general pharmaceutical legislation. We kindly provide our feedback via the attached document and remain at the Commission's disposal to provide further information.
Rare Diseases Ireland is the national alliance for rare disease patient organisations in Ireland. As such we are concerned about innovation and the development and approval of medicines across all rare diseases, and timely access for people living with rare disease to those medicines.
The Council of European Dentists (CED) is a European not-for-profit association representing over 340,000 dentists across Europe. Established in 1961, CED comprises 33 national dental associations from 31 European countries, all of which share a collective commitment to upholding the highest standards of dental care across the European Union (EU).
Europe needs a modern, predictable and sustainable regulatory framework for medicines that truly exists public health for the European population, now and in the future, while strengthening the competences and mandate of Member States responsible for national health care systems. Region Västerbotten is a health care provider and responsible payer in the Swedish national health care system.
Filed in Swedish · English published by the European Commission
Europe needs a modern, predictable and sustainable regulatory framework for medicines that truly enhances public health for the European population, now and in the future, while strengthening the competencies and mandate of Member States responsible for national health care systems. Region Örebro län is a health care provider and responsible payer in the Swedish national health care system.
The European Society for Medical Oncologys (ESMO) Rare Cancers Working Group (RCWG) is a multi-stakeholder partnership which brings together scientific societies, patient and research organisations, healthcare and education providers, and industry.
Drug repurposing holds great promise to meet many of the unmet needs that still afflict patients across Europe. Repurposing, the process whereby existing licensed medicines are developed as treatments for diseases for which they are not currently approved, applies across all disease areas, from rare diseases to cancer to the COVID-19 pandemic.
Positioning OF COFARES, S.L ANTE THE PROPOSALS FOR DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use and repealing Directive 2001/83/EC and Directive 2009/35/EC For the attention of the person concerned: Cofares, Sociedad Cooperativa Farmaceutica Española D.S.
Filed in Spanish · English published by the European Commission
The Pharmaceutical Research and Manufacturers of America and its member companies join the European Federation of Pharmaceutical Industries and Associations in raising significant concerns with a number of the proposed revisions to Directive 2001/83/EC and Regulation EC 726/2004.
Kyowa Kirin appreciates the opportunity to provide comments on the European Commissions solicitation of feedback on the revision of the EU General Pharmaceuticals Legislation documents, COM(2023) 192 & COM(2023) 193; dated 26 April 2023. We provide our comments via the attached document for consideration by the European Commission for summarization and further presentation to the European Parliament and Council.
Kyowa Kirin appreciates the opportunity to provide comments on the European Commissions solicitation of feedback on the revision of the EU General Pharmaceuticals Legislation documents, COM(2023) 192 & COM(2023) 193; dated 26 April 2023. We provide our comments via the attached document for consideration by the European Commission for summarization and further presentation to the European Parliament and Council.
The Austrian Economic Chamber welcomes in principle the European Commission’s objectives under the Pharmaceutical Strategy and sees them as an opportunity to strengthen the pharmaceutical base in Austria and Europe.
Filed in German · English published by the European Commission
NVC proposal for further improvements/modifications on the new EU Pharma Directive relating to medicinal products for human use with particular emphasis on: The appropriate definitions of the terminology used: packaging (verb/noun), packing, pack, filling, leaflet, patient information, labeling, label, The external functions delivered through the activity of packaging and the packaging elements used therein.
Regeneron is a leading global biotechnology company using the power of science to bring new medicines to patients. While we applaud the intent of the legislation, overall, we believe that its overall impact is to disincentivise drug development for the EU market. We appreciate the proposals to streamline regulatory processes to expedite the availability of new medicines to EU citizens.
Sanofi acknowledges the objectives of the proposed draft Regulation and welcomes the attempt to improve todays pharmaceutical framework. While we appreciate the streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will pose a major threat to Europes competitiveness in life sciences and its ability to deliver new medicines faster.
TB Alliance welcomes the European Commissions proposed pharmaceutical package, especially with regards to: 1) addressing unmet medical needs, 2) proposing incentives to tackle antimicrobial resistance, 3) regulatory support, and 4) reporting on publicly funded financial support.
Answer to the request for feedback on the revision of the EU general pharmaceutical legislation The European Respiratory Society, (ERS) is one of the leading medical organisations in the respiratory field, with a growing membership spanning over 160 countries.
Sanofi welcomes the objectives of the proposed draft Directive to improve todays system. We appreciate the streamlining and digitisation of regulatory procedures but are concerned that other proposals will pose a major threat to Europes competitiveness in life sciences and its ability to deliver new medicines faster.
The European Association for Nuclear Medicine (EANM) welcomes the European Commission´s initiative for a revision of the pharmaceutical legislation package for the European Union. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous development, especially in the last two decades.
European Federation of Pharmacy Chains (EFPC) welcomes the opportunity to contribute to the revision of the EUs general pharmaceutical legislation. We believe that our comments, together with harnessing the potential of pharmacies, can contribute to the development of regulation that ensures high level of public health protection, patient safety and access to safe, effective and affordable medicines.
The reform of the EUs pharmaceutical sector is a milestone of the European Health Union and a credible step in our collective step to pave the way towards a healthier, more resilient, and more equal Europe.SFEE fully supports the challenges of enhancing the availability and acceptability of medicines, all fostering a competitive innovation environment in Europe.
Filed in Greek · English published by the European Commission
As part of the globally active Fresenius Group, headquartered in Bad Homburg, Germany. Fresenius Kabi corporate philosophy is caring for life. Our generics and biosimilars play a crucial role in ensuring access to medicines with 15,000 employees in Europe alone and our production facilities in France, Germany, Austria, Italy, Sweden, and other countries, we contribute to Europe's health sovereignty.
Please find attached GIRP's contribution to the European Commissions public consultation on the Revision of the EU general pharmaceuticals legislation. GIRP, the European Healthcare Distribution Association, welcomes the revision of the EU General Pharmaceutical Legislation and the opportunity to provide feedback to the European Commission on the published text.
Dear ladies and gentlemen, the German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the…
The vfa is the association of research pharmaceutical companies in Germany. We represent the interests of 49 world-leading pharmaceutical companies and over 100 subsidiaries and sisters in health, research and economic policy. The members of the vfa represent more than two thirds of the total German pharmaceutical market and employ around 94.000 people in Germany.
Filed in German · English published by the European Commission
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
Focusing on the provisions of the Regulation, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by rejecting the proposed transferable exclusivity vouchers for novel antimicrobials.
Focusing on the Directive, we would stress the importance of: 1. Ensuring predictability and legal certainty to prevent delays in access to generic and biosimilar medicines, by: a) clarifying the Bolar provision to allow immediate day-1 competition after IP expiry, through the inclusion of the supply of EU produced APIs for obtaining marketing authorisations (API supply, offer, export, manufacturing) and all…
pharma.be supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
Novavax is a global company that promotes improved health by discovering, developing, and commercializing innovative vaccines to help protect against serious infectious diseases. Our COVID-19 vaccine was the first protein-based option available in Europe during the pandemic. Novavax employs over 1,600 people worldwide, which gives us a unique perspective as a smaller-sized vaccine manufacturer.
The European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) welcome the initiative to revise the EU pharmaceutical legislation ('the revision'). Today, high pharmaceutical prices often coupled with incomplete evidence affect national pricing and reimbursement (P&R) decisions and consequently access to treatment.
The new proposal of the European Commission offers the possibility to strengthen environmental issues comparably to other objections of the authorisation process of a medicinal product for human use. The new provisions meet the requirements set by the EU with the Strategic Approach on Pharmaceuticals, the Pharmaceutical Strategy and the Chemicals Strategy, including the Zero Pollution Ambition.
As the umbrella organisation bringing together oral health organisations active in Europe, the Platform for Better Oral Health in Europe welcomes the European Commissions ambition to review the EUs pharmaceutical framework and address areas of unmet medical need, particularly in the area of antimicrobial resistance (AMR).
Introduction Biofortis is a global contract research organisation offering comprehensive services in nutrition clinical trials, microbiome sourcing and investigation and data science for human and animal health. For 20 years, Biofortis has specialised in the design and conduct of expert clinical studies and microbiome samples collection for drug purposes under the GMP and the GCP guidance.
Filed in French · English published by the European Commission
*Introduction MaaT Pharma, a clinical-stage biotechnology company committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation. The companys Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome (eg: the entire microbiome ecosystem) in…
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
The vfa is the association of research pharmaceutical companies in Germany. We represent the interests of 49 world-leading pharmaceutical companies and over 100 subsidiaries and sisters in health, research and economic policy. The members of the vfa represent more than two thirds of the total German pharmaceutical market and employ around 94.000 people in Germany.
Filed in German · English published by the European Commission
Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a European portfolio comprising more than 1,400 approved molecules across all major therapeutic areas. Annually, Viatris supplies 36.8 billion doses of medicine in Europe, contributing significantly to equitable access to medicines in the region.
Viatris is a global healthcare company, uniquely positioned to bridge the traditional divide between generics and brands, with a European portfolio comprising more than 1,400 approved molecules across all major therapeutic areas. Annually, Viatris supplies 36.8 billion doses of medicine in Europe, contributing significantly to access to medicines in the region.
The AMR Industry Alliance (AMRIA), is one of the largest private sector coalitions established (in 2017) to provide sustainable solutions to curb antimicrobial resistance (AMR), with over 100 biotech, diagnostics, generics and research-based pharmaceutical companies and associations joining forces.
As the global voice of the Advanced Therapy Medicinal Product (ATMP) sector, the Alliance for Regenerative Medicine (ARM) welcomes the European Commissions ambition to strengthen the EUs pharmaceutical framework to ensure it meets the needs of patients in Europe and creates a conducive environment for the development of innovative medicines.
HCWH Europe supports the Commissions approach towards a greater inclusion of environmental provisions in the revision of the pharmaceutical legislation of the European Union. The proposed package takes into account the harm that the release of pharmaceuticals in the environment has and offers solutions to control and minimise the impact of pharmaceutical compounds, including new rules for Environmental Risk…
Gravis Gioconda’s Polish Sickness Association would like to present its opinion and thank you for giving us the opportunity to speak on this important issue. The association works for the well-being of people suffering from a city. Towns are rare diseases, so we will only look at this area. We are concerned about the reduction of R & D incentives, which may result in fewer innovative medicines for patients.
Filed in Polish · English published by the European Commission
This submission represents the views of the Information Technology and Innovation Foundation. European Union (EU) countries once led the world in biopharmaceutical innovation, with EU-headquartered companies in the last half of the 1970s producing more than twice as many new-to-the-world drugs as American ones. Unfortunately, Europes competitiveness in life-sciences innovation has slipped considerably since.
Belgian Association of Nuclear Medicine (BELNUC), a non-profit making organization Board members : President Prof. Dr. Koen VAN LAERE, UZ Leuven; General Secretary Dr. Géraldine GEBHART, Institut Jules Bordet; President-Elect Prof. Dr. Nadia WITHOFS, CHU de Liège; General Secretary-Elect Prof. Dr. Vanessa SCHELFHOUT, UZ Gent; Dr. Sophie BOURGEOIS, UZ Brussel; Dr. Anne DELCOURT, Mouscron Hospital; Dr.
Eli Lilly & Company (Lilly) is an innovative R&D-driven biopharmaceutical company. We support the Commissions objectives to improve patient access in Europe and boost Europes competitiveness. The reform presents an opportunity to simplify, speed and future proof regulatory procedures to ensure new innovations in company pipelines reach patients.
Eli Lilly & Company (Lilly) is an innovative R&D-driven biopharmaceutical company. We support the Commissions objectives to improve patient access in Europe and boost Europes competitiveness. The reform presents an opportunity to simplify, speed and future proof regulatory procedures to ensure new innovations in company pipelines reach patients.
Introduction Inrae is the French Public Research Institute for Agriculture, Food and the Environment. It has had a leading position in the development of microbiome science and its application for human, animal and plant health.
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
Regulatory Aspects ECPC welcomes the proposal to involve patients in the regulatory cycle of medicines, such as in the Committee for Medicinal Products for Human Use within the EMA. However, we recommend that the new EMA governance structure considers patient involvement throughout the whole development and evaluation cycle of new medicines in order to improve the outcomes and the implementation of the regulatory…
Intergraf represents the European printing industry. Intergraf contribution addresses the provision on package leaflets (article 63.3). The proposal presents a revolutionary approach in granting the flexibility to Member States to remove paper leaflets from the packaging to rely only on the information made available online through the electronic product information.
European community pharmacists support the European Commission's proposal for the reform of the EU pharmaceutical legislation. PGEU believes the proposal includes important provisions to improve the supply of medicines to meet patients needs, regardless of where they live in the Union.
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
The National Adult Literacy Agency (NALA) in Ireland is a registered charity with close to 2,000 members. We believe literacy is a human right. We are committed to making sure people with unmet literacy, numeracy and digital literacy needs can fully take part in society and have access to quality learning opportunities that meet their needs.
New category of biological medicinal products relevant for microbiome-based drugs NovoBiome supports the introduction of a new category of SoHO-derived medicinal products in the proposed Directive on the Union code relating to medicinal products for human use.
We welcome in principle the objective of ensuring the EU’s supply of safe and affordable medicines, cutting red tape and at the same time supporting the innovation efforts of the EU pharmaceutical industry. The pharmaceutical industry is a major source of innovation for Europe, triggering large (volks) economic and health-related leverage.
Filed in German · English published by the European Commission
VCI and its associated professional associations represent the interests of approximately 1,900 companies in the chemical and pharmaceutical industry and related sectors vis-à-vis politics, authorities, other areas of the economy, science, and the media. In 2022, the member companies of the VCI generated sales of around 260 billion euros and employed nearly 550,000 employees.
The Novo Nordisk Foundation is a Danish enterprise foundation with philanthropic objectives. The vision of the foundation is to enhance human health and the sustainability of society and the planet. The Novo Nordisk Foundation has its mission to advance research and innovation in the prevention and treatment of cardiometabolic and infectious diseases, including addressing antimicrobial resistance (AMR), while also…
VCI and its associated professional associations represent the interests of approximately 1,900 companies in the chemical and pharmaceutical industry and related sectors vis-à-vis politics, authorities, other areas of the economy, science, and the media. In 2022, the member companies of the VCI generated sales of around 260 billion euros and employed nearly 550,000 employees.
On behalf of the Association Innovative Medicines (VIG), the Dutch industry association of 44 innovative medicines manufacturers, our response to the proposed revision of the EU pharmaceutical legislation. The members of the VIG are active in the biopharmaceutical ecosystem of the Netherlands, which extends from academic institutions and hospitals to medicine developers and service companies.
Filed in Dutch · English published by the European Commission
On behalf of the Association Innovative Medicines (VIG), the Dutch industry association of 44 innovative medicines manufacturers, our response to the proposed revision of the EU pharmaceutical legislation. The members of the VIG are active in the biopharmaceutical ecosystem of the Netherlands, which extends from academic institutions and hospitals to medicine developers and service companies.
Filed in Dutch · English published by the European Commission
Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcoming the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70 % of medicines dispensed in Europe covering 80 % of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…
Filed in Polish · English published by the European Commission
Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and…
The German Society for Nuclear Medicine (DGN) together with the Professional Association of German Nuclear Medicine Practitioners (BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission’s initiative for a revision of the pharmaceutical legislation package for the European Union.
Filed in German · English published by the European Commission
As with other integrative medical systems, Anthroposophic Medicine is based on a holistic approach; it merges conventional and complementary medicine and it includes all dimensions of the patient: physical, emotional, mental and spiritual, as well as the impact of a person's environment and social context.
On 26 April 2023, the European Commission published proposals for the reform of the EU pharmaceutical legislation revising existing legislation on medicines, with the aim of increasing the availability of medicines and vaccines, while at the same time strengthening scientific research and innovation in Europe for the benefit of patients.
Filed in Danish · English published by the European Commission
The German Society for Nuclear Medicine (DGN) together with the Professional Association of German Nuclear Medicine Practitioners (BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission’s initiative for a revision of the pharmaceutical legislation package for the European Union.
Filed in German · English published by the European Commission
Grifols welcomes the goals of the European Commissions revision of the European Unions pharmaceutical legislation to improve access to medicines and to foster the sectors innovation and competitiveness. We are a leading European healthcare company that develops plasma-derived medicinal products (PDMPs) to treat chronic, severe, and at times life-threatening conditions.
The European Technology Platform on Nanomedicine (ETPN) finds the new EU pharmaceutical legislation largely aligned with its objectives of enhancing drug availability, accessibility, and innovation. It commends the efforts to expedite EMA authorization timelines and address drug shortages but suggests greater industrial accountability and supply chain security strategies.
The European Joint Programme on Rare Diseases (EJP RD) hereby shares its view on the revision of the EU general Pharmaceuticals Legislation with particular reference to orphan medicinal products. CRITERIA FOR ORPHAN DESIGNATION The derogations to the prevalence-based criterion introduced in the proposal are not clearly stated, should be included in the legislation and regularly updated, as they would lead to a…
The revision of the EU pharmaceutical legislation is key to shaping market conditions for the pharmaceutical industry and, above all, to improve patients’ access to innovative medicines. The final form of these rules will depend on the competitiveness and safety of Europe’s medicines, the access of Europeans to state-of-the-art medicines technologies and the economic development of European Union countries.
Filed in Polish · English published by the European Commission
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
The use of the molecular target concept is in line with the US RACE for Children Act and meets our expectations of harmonising the global regulatory environment. We consider the provision of specific additional data protection (24 months) for the introduction of a new medicine in all Member States set out in the proposal for a directive as a major step towards eliminating inequalities in childhood and adolescent…
Filed in Greek · English published by the European Commission
The French Society of Nuclear medicine and Molecular Imaging together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous development, especially in the last two decades.
Polish Confederation Lewiatan is the biggest trade association in Poland. We represent over 4,000 companies brought together in 34 industry and 20 regional associations. Over 20 companies are direct members of Lewiatan. Our members employ over a million employees.
On 26 April 2023, the European Commission published proposals for the reform of the EU pharmaceutical legislation revising existing legislation on medicines, with the aim of increasing the availability of medicines and vaccines, while at the same time strengthening scientific research and innovation in Europe for the benefit of patients.
Filed in Danish · English published by the European Commission
The EU is a high priority region for GSK, our medicines and vaccines are used to treat and prevent diseases for millions of EU citizens each year and it is a significant location for our R&D and manufacturing footprint.
The EU is a high priority region for GSK, our medicines and vaccines are used to treat and prevent diseases for millions of EU citizens each year and it is a significant location for our R&D and manufacturing footprint.
The Austrian Society of Nuclear Medicine and Molecular Imaging (OGNMB), together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
Bayer is grateful for the opportunity to engage in the dialogue concerning the pharmaceutical legislation reform. Alongside our primary recommendations below, additional details can be found in the annex. Bayer has a 160-year legacy of European innovation and proudly maintains 11 Pharma R&D and production facilities throughout Europe.
Bayer is grateful for the opportunity to engage in the dialogue concerning the pharmaceutical legislation reform. Alongside our primary recommendations below, additional details can be found in the annex. Bayer has a 160-year legacy of European innovation and proudly maintains 11 Pharma R&D and production facilities throughout Europe.
The International Council on Animal Protection in Pharmaceutical Programs (ICAPPP) welcomes the opportunity to provide feedback on the revision of the EU general pharmaceuticals legislation for human use. ICAPPP works to foster innovation in non-animal methods and thereby adapt to scientific and technological developments, e.g., by 'future proofing' legislations.
The pharmaceutical legislation must be changed for radiopharmaceutical in order not to jeopardize patient interests. One unique advantage is that radiopharmaceutical are usually very well tolerated by patients. Radiopharmaceuticals provide unique and valid information for patient management which cannot be supplemented by other techniques.
AELMHU, Asociación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuérfanos, a non-profit organization that brings together 25 biotechnology and pharmaceutical companies committed to the discovery, research, development and commercialization of innovative therapies capable of improving the situation of patients living with rare and ultra-rare diseases, appreciates the opportunity to participate in this…
MLPS Feedback for Directive on Medicinal Products for Human Use: MLPS (Medical Leaflets = Patient Safety), a subgroup of the European Carton Makers Association, expresses its concerns regarding the European Commission's proposed Directive on medicinal products for human use, related to the use of electronic product information (ePI).
FIAGOP (fiagop.it) – Federazione Italiana Associazioni Gentori e Riciti Oncohematologia Pediatrica, was founded in 1995 with the aim of creating synergies between associations present in Italy and ensuring institutional representation at both national and international level.
Filed in Italian · English published by the European Commission
The PRI welcomes the proposal for a pharma Regulation which will forge further EU harmonization in terms of the quality, safety, and efficacy assessment of "SoHO-derived medicinal products other than ATMPs (hereinafter abbreviated SoHO-DMP). Integration of provisions addressing Orphan and Pediatric medicinal products within the proposal for Regulation is also welcome as it serves for better centralization.
The PRI welcomes the proposal for a new Directive as it is a step towards recognizing microbiome-based medicinal products by defining SoHO-derived medicinal product other than ATMPs (hereinafter abbreviated SoHO-DMP) (which will include microbiome-based medicinal products produced from human microbiomes). However, specific requirements applicable to these products remain unknown.
Mundipharma welcomes the objective of the planned EU pharmaceutical legislation particularly in respect to more efficient regulatory processes, stronger voice for patients and easier access to information. We would like to provide the comments below on other proposals. Art.
As the Austrian Association of Public Economics and Public Sectors (VÖWG) and thus also representatives of public health institutions in Austria, we welcome the initiative to revise the general pharmaceutical legislation in the European Union. In recent years, there have been some shortcomings in the existing rules.
Filed in German · English published by the European Commission
To believe – Association of parents and friends of children with cancer, welcomes the revision of the general EU legislation on pharmaceuticals. As members of the wider community of paediatric oncology, Childhood Cancer International (JRC) has made public the need to revise this regulation in several actions. Therefore, briefly, we leave here the main points developed in the file.
Filed in Portuguese · English published by the European Commission
Vereniging Kinderkanker Nederland/VKKN (Dutch Childhood Cancer Organization Childhood Cancer) member of Childhood Cancer International Europe (CCI-E) . CCI-E has actively participated in the review of EU regulations pertaining to pediatric and orphan medicines since 2012.
The European Patients Forum (EPF) welcomes the long-awaited revision of the EU pharmaceutical legislation. This is a unique opportunity to make the EU regulatory framework for the authorisation of medicines more patient-centred, aiming for fair access to medicines.
The German Society of Radiopharmaceutical Science (Gesellschaft für Radiopharmazeutische Wissenschaften e.V., grpw) fully supports the joint feedback of DGN, BDN and EANM! The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European…
Some comments relating the Directive proposal. Further details are needed on how the MA Holder should comply with the new extensive requirements for the environmental risk assessment, about the inclusion of risks related to antimicrobial resistance. In general, for antimicrobials, more information would be needed on the implementation of the stewardship plan.
Ipsen, a global biopharmaceutical company committed to improving patients' lives through breakthrough innovations, focuses on unmet medical needs, particularly in oncology, rare diseases and neuroscience. We support the objectives of the reform but urge more ambition to foster innovation for people with rare diseases and improve Europes competitiveness and attractiveness.
The Avicenna Alliance represents a collaborative effort among stakeholders committed to advancing in silico medicine. This initiative harnesses the power of computer modelling and simulation to revolutionize the development and delivery of innovative medical treatments.
The Avicenna Alliance represents a collaborative effort among stakeholders committed to advancing in silico medicine. This initiative harnesses the power of computer modelling and simulation to revolutionize the development and delivery of innovative medical treatments.
The INC has the pleasure of submitting its feedback prepared in consultation with the interinstitutional WG on oncopediatrics of the 2nd National Cancer Plan of Luxembourg. -Science-based paediatric drug development: We value the introduction of paediatric medicine development based on the molecular target. This acknowledges that children deserve access to treatments designed with their specific needs in mind.
The Swedish Society for Nuclear Medicine (SFNM) together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union. Nuclear Medicine is a powerful tool for diagnosis and treatment of a variety of diseases and has seen a tremendous development, especially in the last two decades.
Childhood Cancer International Europe (CCI-E), the largest European patients organisation in paediatric cancer, welcomes the proposal by the European Commission for revision of the EU Pharmaceutical legislation as it addresses several areas of concern of the paediatric cancer community.
Childhood Cancer International Europe (CCI-E), the largest European patients organisation in paediatric cancer, has been involved in the review of the EU Paediatric and Orphan Regulations since 2012. We welcome the proposal by the Commission for revision of the EU Pharmaceutical legislation as it covers some areas of concern of the paediatric cancer community.
Haleon, a global leader in consumer health with a purpose to deliver better everyday health with humanity, welcomes the overall objectives of the European Commissions proposal for a revision of the EUs General Pharmaceutical Legislation. We also acknowledge and commend the patient-centred approach that the European Commission has chosen to adopt in its Pharmaceutical Strategy.
Introduction To be truly future proof and innovation friendly, the EU's proposed pharmaceutical package must address the blocs declining attractiveness for investment. We therefore urge EU co-legislators to secure globally competitive incentives for research and development (R&D) and avoid additional unnecessary administrative burdens on companies.
Medicines for Europe, member of The PTG, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to…
Introduction To be truly future proof and innovation friendly, the EU's proposed pharmaceutical package must address the blocs declining attractiveness for investment. We therefore urge EU co-legislators to secure globally competitive incentives for research and development (R&D) and avoid additional unnecessary administrative burdens on companies.
The Union general pharmaceutical legislation was established in 1965 with the dual objective of safeguarding public health and harmonising the internal market for medicines. The latest proposal of the European Commission for revision of this legislation including a new Directive and a new Regulation to replace pharmaceutical legislation currently in force, with the overall objectives of promoting innovation…
Filed in German · English published by the European Commission
Opinion on behalf of a member of the Polish Economic Society - Medicines for Poland. Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation.
Childhood Cancer International Europe (CCI Europe), the largest European patient organisation in paediatric cancer, has been involved in the review and analysis process of the EU Paediatric Regulation since 2012 and the EU Orphan Regulation since 2016.
Farmaindustria (FI) supports the ultimate objective of the EC Proposal to improve the availability and access to medicines by promoting an innovative and competitive environment in the EU. We welcome the intention to prepare a regulatory framework for the future, maximising the use of fast-track procedures, optimising regulatory decision-making processes and reducing unnecessary red tape.
Filed in Spanish · English published by the European Commission
Recent research by scholars at Bayes Business School, City University of London, aimed at understanding how Europe can regain its competitive advantage in attracting pharmaceutical companies to submit their innovative medicines before any another region.
This response focuses solely on the European package leaflet. The current European package leaflets are not clear and understandable and they do not enable users to act appropriately. Package leaflets are too long, use small type, are hard to read, are difficult to understand, and are onerous to use.
The International Institute for Information Design (IIID) welcomes the opportunity to provide feedback about the Proposal for a Revision of the European Pharmaceutical legislation. The International Institute for Information Design is a membership organization that represents the Information Design profession. IIID was established in 1987 and is based in Vienna, Austria.
The PRISMAP- consortium (European Network for Medical Radionuclides) would like to highlight the impact of the revision of the EU pharmaceutical legislation on the future development and clinical access of radiopharmaceuticals based on innovative production of novel radionuclides.
CSL Behring welcomes the overall objectives of the proposed Pharmaceutical Package to enhance the availability and accessibility of medicines, while fostering a future-proof, crisis-resistant life science industry environment.
ESOP Global: response to the new EU pharmaceutical legislation proposal The members of ESOP Global, who represent health care professionals from 67 countries worldwide including all countries inside the European Union, applaud the presented proposals for the new legislative pharmaceutical framework. The needs of our patients have been placed at the center of the revision.
To whom this may concern, Please find attached PHOENIX group contribution to the European Commissions public consultation on the Revision of the EU general pharmaceuticals legislation. PHOENIX group applauds the European Commission for reviewing and updating the outdated European pharmaceutical legislation for the benefit of European patients.
2 November 2023 European Commission, Directorate-General for Health and Food Safety Reference: CELEX number: 52023PC0193 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU)…
CPME welcomes the strong focus on addressing medicine shortages and strengthening security of supply in the revision, especially by proposing earlier notifications, clear definitions of shortages and an obligation of having in place shortage prevention plans.
Science Based Paediatric Medicine Development: We welcome the introduction of paediatric medicine development based on the molecular target of a new medicine in the Commissions proposal. Improved access to essential anticancer medicines: We support the introduction of a dedicated chapter on the shortages of medicine and the EU-wide list of critical medicines.
The German Medicines Manufacturers’ Association (BAH) fully shares the goals of the legislative package for the reform of the EU pharmaceutical legislation, ensuring that patients all across the EU have timely and equitable access to safe, effective, and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive to manufacturing and continuous innovation.
Filed in German · English published by the European Commission
The German Medicines Manufacturers’ Association (BAH) fully shares the goals of the legislative package for the reform of the EU pharmaceutical legislation, ensuring that patients all across the EU have timely and equitable access to safe, effective, and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive to manufacturing and continuous innovation.
Filed in German · English published by the European Commission
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
The German speaking working group radiochemistry/radiopharmacy (AGRR), representing radiopharmacists and radiopharmaceutical chemists from the D-A-CH region, strongly supports the following statement: The German Society for Nuclear Medicine (DGN) together with the Professional Association of German Nuclear Medicine Practitioners (BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European…
Filed in German · English published by the European Commission
The Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM) together with the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
My comments concern the proposed four-year period of data protection for repurposing under Article 84 of the proposed Directive. I query how effective it will be. To summarise the proposed article: developers will be eligible for the protection period if a) they conduct non-clinical or clinical studies demonstrating a new indication is of significant clinical benefit and b) 25 years have passed since the product was…
The German Social Insurance Board (DSV) welcomes the Commission’s objectives of the reform proposals. They provide an opportunity to ensure equal access to medicines for patients in all Member States and to strengthen the security of supply of medicines as well as the adequacy of existing incentive schemes for drug development.
Filed in German · English published by the European Commission
The German Society for Nuclear Medicine (DGN) together with the Professional Association of German Nuclear Medicine Practitioners (BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission’s initiative for a revision of the pharmaceutical legislation package for the European Union.
Filed in German · English published by the European Commission
Calliditas supports the Commission´s objectives regarding availability and accessibility of medicines, while supporting an innovative EU. However, we have serious concerns that the legislation will accelerate the erosion of the EU competitiveness, jeopardizing jobs and growth and negatively impacting patients access to innovative medicines in the EU.
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
2 November 2023 European Commission, Directorate-General for Health and Food Safety Reference: CELEX number: 52023PC0192 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC COM/2023/192 final Dear Sir or Madam, The International Society for Pharmaceutical Engineering (ISPE)…
The LIF welcomes the Commission’s initiative for a modernised regulatory framework for medicines that can be more easily adapted to technological and medical developments. The LIF considers that the Commission’s objective of creating more equal access to new medicines between EU Member States is important. On the other hand, the proposal contains several elements to which Lif has strong objections.
Filed in Swedish · English published by the European Commission
Replies to the EU Commission deadline 7 November 2023 Lif welcomes the Commission’s initiative for a modernised regulatory framework for medicines that can be more easily adapted to technological and medical developments. The LIF considers that the Commission’s objective of creating more equal access to new medicines between EU Member States is important.
Filed in Swedish · English published by the European Commission
As the umbrella organisation of the 1887 German hospitals in public, non-profit and private ownership, the German Hospital Company (DKG) has been participating constructively in health policy debates at EU level for many years.
Filed in German · English published by the European Commission
Additional information from PASMI of the Association of Employers of the Polish Association of Medicines Producers without Prescription to the European Commission’s position on the revision of the European Pharmaceutical Law on 21 August 2023 in the following area: 1.
Filed in Polish · English published by the European Commission
With 49 billion of production in 2022, of which 47,6 were exports, 3,3 billion of investment, the pharmaceutical industry in Italy is a strategic asset for national and EU economics. Farmindustria supports the EU Commission’s objectives of improving the availability and accessibility of medicines, promoting EU competitiveness and establishing a modern regulatory framework to speed up procedures, optimise processes…
Filed in Italian · English published by the European Commission
With 49 billion of production in 2022, of which 47,6 were exports, 3,3 billion of investment, the pharmaceutical industry in Italy is a strategic asset for national and EU economics. Farmindustria supports the EU Commission’s objectives of improving the availability and accessibility of medicines, promoting EU competitiveness and establishing a modern regulatory framework to speed up procedures, optimise processes…
Filed in Italian · English published by the European Commission
BPI welcomes the revision of the EU´s general pharmaceutical legislation and the Pharma Package (EU Pharmaceutical Legislative Revision) published by the European Commission on 26 April 2023. After more than 20 years, a revision of the existing provisions was necessary to ensure a legal framework that is adapted to the state of technology and research, while reducing bureaucracy to ensure that medicinal products can…
IRE or National Institute of Radioelements is a public utility foundation, whose main activity is the production of medical radioisotopes for diagnostic and therapeutic applications in the field of nuclear medicine.
In Europe, 6.172 rare diseases have been identified, although it is estimated that there may be more than 7.000 rare diseases worldwide. Of these, only 6 % have treatment, so that, in general terms, scarcity of treatment is the main barrier for those living with these diseases.
Filed in Spanish · English published by the European Commission
Pfizer supports the EFPIA submission to this call for feedback and appreciates the opportunity to elaborate further on some key areas. Pfizer shares the European Commissions goals to deliver faster, more equitable access to affordable medicines and mitigate shortages. We are driven by the understanding that patients cant afford any delays or disruptions in getting the medicines and vaccines they need.
The labeling of the primary packaging (vial) of radiopharmaceuticals is a practice that involves investigative procedures for the manufacturer, with onerous repercussions (procedural and structural). We know that for radiation protection issues, the vial containing radiopharmaceutical cannot be handled so the label on the vial cannot be read by practitioners in Nuclear Medicine, at least as long as it is…
Medicines for Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…
Medicines for Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and…
Comment on Article 68 The labelling of the immediate packaging of radiopharmaceuticals (in particular those used in PET) is a practice which increases the risks and does not bring any clinical or safety benefit to the user.
Filed in Italian · English published by the European Commission
The German Society for Nuclear Medicine (Deutsche Gesellschaft für Nuklearmedizin, DGN) together with the Professional Association of German Nuclear Medicine Practitioners (Berufsverband Deutscher Nuklearmediziner, BDN) and the European Association for Nuclear Medicine (EANM) welcomes the European Commission`s initiative for a revision of the pharmaceutical legislation package for the European Union.
The European Organisation for Research and Treatment of Cancer (EORTC), with a mission to design, coordinate, and conduct multidisciplinary clinical and translational trials to improve the standard of cancer treatment for patients, welcomes the proposal to review the EU general pharmaceutical legislation. Many drugs enter the market without evidence of their true clinical benefit for patients.
PPTA welcomes the EC's proposal for the Regulation on the EU general pharmaceutical legislation (GPL) and its aim to harmonise regulatory provisions for manufacturers of medicines in the EU while ensuring better availability of medicines for EU patients. Overall, GPLs focus on strengthening the EU pharmaceutical supply chains is encouraging.
PPTA welcomes the Commission's proposal for revision of the EU general pharmaceutical legislation and supports the overall objective to harmonise the rules governing pharmaceuticals in order to ensure better availability of medicines for EU patients. We welcome a more comprehensive definition of SoHO-derived medicinal product (Article 4 point 31).
The European Society for Medical Oncology (ESMO) is one of the leading professional organisations for medical oncology, with more than 33,000 members from over 170 countries. ESMO is committed to preventing new cancer cases, improving the quality of cancer care and promoting equal access to optimal treatments for all cancer patients.
IndustriAll European Trade Unions full position will be uploaded as annex to this feed-back. The proposal for a new pharmaceutical legislation in Europe broadly addresses relevant issues to ensure a safe and supportive supply for patients.
Per generic product is the association of generic and biosimilar companies in Germany. Our member companies are the guarantor of the German health system’s promise that every patient will have access to modern and affordable drug therapies.
Filed in German · English published by the European Commission
The collaborative National Paediatric Formularies from the Netherlands, Germany, Austriaand Norway have made it their mission to ensure that all children in Europe, like adults, have the right to the best possible, knowledge-based pharmacotherapy guided by reliable information to caregivers.
Takeda is a patient-focused, values-based, R&D-driven biopharmaceutical company committed to delivering highly innovative medicines and transformative care to improve lives worldwide. Takeda supports the Commissions objectives for the revision of the EU pharmaceutical legislation: the ambition for timely access and enhanced availability of medicines across Member States, more efficient regulatory processes, and an…
Takeda is a patient-focused, values-based, R&D-driven biopharmaceutical company committed to delivering highly innovative medicines and transformative care to improve lives worldwide. Takeda supports the Commissions objectives for the revision of the EU pharmaceutical legislation: the ambition for timely access and enhanced availability of medicines across Member States, more efficient regulatory processes, and an…
ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, represents an EU-based industry that has been serving the European market for decades. EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States; the EU being the global centre of expertise in manufacturing, quality standards and regulation of this industry.
ECHAMP, the European Coalition on Homeopathic and Anthroposophic Medicinal Products, represents an EU-based industry that has been serving the European market for decades. EU legislation for homeopathic medicinal products has deep roots in their broad use in the Member States; the EU being the global centre of expertise in manufacturing, quality standards and regulation of this industry.
Compared to adults, children face lack of effective treatments, increased adverse events due to off-label medication use, and limited access to appropriate medicines. Currently, only 35% of marketed drugs have been specifically developed and approved for paediatric use, leading to significant risks and challenges for this vulnerable population.
FarmaForum, the Slovenian innovative pharmaceutical industry association recognizes the need for comprehensive regulations and standards and welcomes the European Commission legislative initiative aimed at modernising the pharmaceutical legislation.
FarmaForum, the Slovenian innovative pharmaceutical industry association recognizes the need for comprehensive regulations and standards and welcomes the European Commission legislative initiative aimed at modernising the pharmaceutical legislation.
Roche supports EFPIAs response to this consultation. Deeply rooted in Europe, Roche is concerned that the future legislation, if adopted as is, will have a detrimental impact on access to innovation for EU patients and will exacerbate innovation and competitiveness gaps between the EU and other regions of the world.
ALAN asbl Maladies Rares Luxembourg, the rare disease alliance of Luxembourg supports the objectives of the legislation. However, we see three areas of improvement namely: patient engagement, the concept of unmet needs and pediatric medicine. Patient engagement Although we welcome the initiatives to improve patient engagement as described in the current proposal, we see multiple areas of improvement described below.
Pharma Industry Finland (PIF) supports the objectives of promoting a competitive and innovation-friendly environment for R&D in Europe and enhancing the availability and accessibility of medicines for patients. We encourage, in particular, the creation of structures for a faster marketing authorisation process, reducing unnecessary administrative burdens, and the introduction of a transferable exclusivity voucher as…
Pharma Industry Finland (PIF) supports the objectives of promoting a competitive and innovation-friendly environment for R&D in Europe and enhancing the availability and accessibility of medicines for patients. We encourage, in particular, the creation of structures for a faster marketing authorisation process, reducing unnecessary administrative burdens, and the introduction of a transferable exclusivity voucher as…
IML represents 64 research-based pharmaceutical companies operating in Luxembourg. Our members are committed to researching, developing, and bringing to patients new medicines that improve health and the quality of life. Our association supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe.
IML represents 64 research-based pharmaceutical companies operating in Luxembourg. Our members are committed to researching, developing, and bringing to patients new medicines that improve health and the quality of life. Our association supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe.
The European Blood Alliance, representing public/not-for-profit blood establishments, welcomes the European Commissions publication of its proposal for a reform of the EU pharmaceutical legislation. The review aims to reach a number of important goals, such as improving access to innovative medicines, promoting innovation in the sector and addressing shortages.
Compared to adults, children face lack of effective treatments, increased adverse events due to off-label medication use, and limited access to appropriate medicines. Currently, only 35% of marketed drugs have been specifically developed and approved for paediatric use, leading to significant risks and challenges for this vulnerable population.
The Medtech & Pharma Platform Association (MPP) welcomes the proposals objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness. We would like to propose amendments on points which are of importance for products combining medicines and medical devices including in-vitro diagnostics and therefore fall under the scope of both the medicinal…
The Medtech & Pharma Platform Association (MPP) welcomes the proposals objectives to improve the availability and accessibility of medicinal products throughout the EU and support industry competitiveness. We would like to propose amendments on points which are of importance for products combining medicines and medical devices including in-vitro diagnostics and therefore fall under the scope of both the medicinal…
In the last 20 years, biotech transformed the pharmaceutical industry and enabled the development of breakthrough therapies that are live-saving or significantly improving quality of life of patients and their families. The development of biotech in Europe also continues to positively contribute to the regions economic well-being.
Merck, as the oldest innovative pharmaceutical company in the world with strong commitment to innovation, and deep roots in Europe, welcomes the Commissions efforts to improve pharmaceutical legislation. The proposed regulatory changes, including measures to reduce assessment timelines, modernize and future-proof the EU regulatory network and its frameworks, e.g.
Merck, as the oldest innovative pharmaceutical company in the world with strong commitment to innovation, and deep roots in Europe, welcomes the Commissions efforts to improve pharmaceutical legislation. The proposed regulatory changes, including measures to reduce assessment timelines, modernize and future-proof the EU regulatory network and its frameworks, e.g.
EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
Vaccines Europe (VE) concurs with the responses submitted by EFPIA, whilst raising implications and concerns regarding the proposed GPL revision for vaccines and the industry developing and manufacturing them. Although the vaccine industry is a relatively small part of the pharmaceutical industry, it is particularly important for the EU and its citizens as it delivers more value than any other innovative industry.
As an organisation focused on accelerating the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need, CEPI is aligned with the objectives of the revision to the EU general pharmaceutical legislation and believes that, with adjustments, will further enable CEPIs 100 Days Mission of having vaccines ready for initial…
EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.
APOGEN, Portuguese Generic and Biosimilar Medicines Association represents the companies of generic and biosimilar medicines in Portugal, welcomes the proposals to review the EU general pharmaceutical legislation.
APOGEN, Portuguese Generic and Biosimilar Medicines Association represents the companies of generic and biosimilar medicines in Portugal, welcomes the proposals to review the EU general pharmaceutical legislation.
Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…
Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and…
Van Hest Packaging Concepts play an active role in the creation of labelling & packaging for innovative pharmaceuticals, including orphan drugs and medication for pediatric use. Focus is fully dedicated to the patients, caregivers, healthcare professionals, the environment and to the pharmaceutical industry. Revision of the current EMA guidance is welcomed and fully supported.
LEtablissement Français du Sang (EFS) thanked the European Commission for its proposal, which met some of the stakeholders’ expectations, but created uncertainty about cross-border products. In particular, we would like to welcome the following points: The reaffirmation of the principle of voluntary and unpaid donation left the harmonisation of the framework for ATMPs prepared under hospital exemption The…
Filed in French · English published by the European Commission
The proposed Directive (COM (2023) 192) and the Regulation (COM (2023) 193) contain several important measures that can make the pharmaceutical framework patient-centred and fit for purpose however, some areas could be improved to enhance access to medicines for cancer patients.
Unmet medical needs require sustainable and innovative solutions Unmet medical needs (UMN), especially in areas that are commercially unappealing, may be addressed by drug repurposing, which also has the potential to reduce both development time & cost.
Amsterdam UMCs response to the European Commission's pharmaceutical legislation proposal centers on three crucial aspects: "Market Exclusivity," "Drug Repurposing," and "Hospital Exemption." We advocate for a recalibration of market exclusivity durations to foster competition, the active engagement of academia in drug repurposing, and the removal of constraints on ATMP manufacturing and delivery for improved patient…
The National Association of Pharmacists welcomes the proposals of the pharmaceutical package presented in spring 2023 as a whole. We particularly welcome the proposed ambitious model for monitoring and managing shortages, as well as the focus on antimicrobial resistance and environmental challenges.
Filed in French · English published by the European Commission
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