Bundesverband der Pharmazeutischen Industrie e.V.

The German Pharmaceutical Industry Association (BPI) welcomes the European Commissions revision of the EU Public Procurement Directive, as it presents a crucial opportunity to strengthen pharmaceutical supply security, support European production, and promote sustainable procurement practices. A key factor contributing to medicinal product shortagesgrowing global demandmust be acknowledged.

BPI welcomes the initiative. Targeted amendments are vital to foster innovation, patient safety and sustainable competitiveness within healthcare. BPI therefore advocates for the following: Reduce administrative burdens The current re-certification and post-market surveillance requirements under MDR and IVDR impose disproportionate, duplicative burdensparticularly on SMEs and mid-caps.

The BPI e.V., representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Start-ups. These companies ensure timely and safe drug supply for all patients across the EU and globally.

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…

The BPI e.V. (BPI) representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Startups. These companies ensure a timely and safe supply of medicinal products for all patients across the EU and globally.

BPI welcomes the European Commissions initiative, the EU Biotech Act I, which represents a crucial step towards strengthening Europes biopharmaceutical sector. It particularly supports measures to expand biopharmaceutical manufacturing capacity, reduce dependencies on critical raw materials, accelerate approval procedures, streamline regulatory pathways for advanced therapy medicinal products (ATMPs), and promote…

Biotechnology is essential to the EUs healthcare innovation, enabling advanced treatments and better outcomes for citizens. The BPI sees the EU Biotech Act as a key opportunity to accelerate this progress. For the EU to regain leadership in breakthrough therapies, it must rapidly translate scientific advances into accessible treatments through aligned legislative and non-legislative measures, such as the EU…

BPI welcomes the European Commission's proposed European Innovation Act. The Draghi report highlighted health innovation as key to Europes competitiveness, a perspective also echoed by Commission President Ursula von der Leyen in her State of the Union address, where she underscored the Unions readiness to assume global health leadership.

The Bundesverband der Pharmazeutische Industrie e.V. (BPI) represents more than 270 companies from the entire range of the pharmaceutical industry, from multinationals to SMEs, mid-caps and start-ups. These companies ensure a timely and safe supply of medicines to all patients in Germany, the EU and worldwide.

Filed in German · English published by the European Commission

The German Pharmaceutical Industry Association (BPI) represents the common economic interests of its member companies, particularly in the areas of healthcare and location policy, security of supply and pharmaceutical legislation at state and federal level as well as in Europe.

BPI welcomes the proposal for a Regulation on Substances of Human Origin (SoHO) presented by the European Commission on 14 July 2022 to replace the current EU legislation on blood, tissues and cells (BTC). The European Union needs a predictable, future-proof and resilient regulatory framework for SoHO.

The Bundesverband der Pharmazeutische Industrie e.V. (BPI) represents the common economic interests of its member companies, in particular in the areas of health policy and location policy, security of supply and pharmaceutical legislation at regional and federal level and in Europe.

Filed in German · English published by the European Commission

The BPI is grateful for the Commission’s initiative to streamline reporting requirements with a view to reducing red tape. We would like to address below the reporting obligations arising from the so-called Variation Regulation (Regulation (EU) No 1234/2008 on the examination of variations to the marketing authorisation of medicinal products for human and veterinary use) and the related Classification Guideline, the…

Filed in German · English published by the European Commission

The German Pharmaceutical Industry Association (BPI e.V.), representing more than 270 members, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Start-ups. This also includes companies with a special focus on the development of medicines for children and rare diseases.

The BPI e.V. (BPI), representing more than 270 companies, comprises the whole spectrum of the pharmaceutical industry, ranging from multinational corporations to SMEs, Mid-Caps as well as Start-ups. These companies ensure timely and safe drug supply for all patients across the EU and globally.

It would be our utmost wish to take the chance and comment the intended changes concerning the use of botanical species containing hydroxyanthracene derivatives in food products. Even though we are a pharmaceutical industry association we suspect that herbal medicinal products may be affected by the classification of herbal substances and their preparations to be used in food products.

Dear Sir/Madam, please find attached the opinion on the GMP guide for veterinary medicinal products. We would like to point out that the consultation deadline of only four weeks is considered insufficient to thoroughly assess all specific requirements and possible changes. In addition, the envisaged transitional period of eight months does not provide an adequate possibility for manufacturers to adapt.

Filed in German · English published by the European Commission