EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its members support the EUs ambition to advance a circular economy and share the objective of fostering sustainability while safeguarding public health and the resilience of global supply chains. We are committed to innovation, sustainable manufacturing, and responsible resource use.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the innovative pharmaceutical industry in Europe, creating a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe and support sustainable development.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to submit feedback on the effectiveness of the EU public procurement directives. Recourse to the public procurement of medicines has increased in recent years as payers across the EU struggle to balance constrained healthcare budgets and increasing demand.

EFPIA fully supports the aim of the targeted revision for the MDR/IVDR to simplify and streamline the current regulatory framework. However, the proposal misses the opportunity to enhance the current system even further. On the governance process, EFPIA supports a greater coordination role taken by the EMA as well as expansion of expert panels remits.

EFPIA welcomes the European Commissions call for evidence gathering input to address the identified problems highlighted in the MDR-IVDR targeted evaluation of March 2025 and is providing input related to drug-device/diagnostic used together (combined products) during clinical development and life cycle.

The European Commissions initiative to propose an EU Inc. corporate legal framework is a strong structural reform to support competitiveness and innovation in Europe. This proposal to reduce legal and administrative fragmentation is welcome by EFPIA and especially its SME members which experience the difficulty to scale up their business in Europe.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for feedback on the review of the EU Taxonomy Environmental Delegated Act.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence in for the review of Climate Delegated Act. EFPIA represents the biopharmaceutical industry operating in Europe, bringing together 36 national associations, 40 leading pharmaceutical companies and a growing number of small and medium-sized enterprises.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence in for the review of Environmental Delegated Act. EFPIA represents the biopharmaceutical industry operating in Europe, bringing together 36 national associations, 40 leading pharmaceutical companies and a growing number of small and medium-sized enterprises.

EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.

EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.

EFPIA strongly support the ambition to foster a world-class innovation environment for biotechnologies.To make the EU more attractive for researching, developing and manufacturing new technologies,we urge coordinated and urgent action across several areas.

EFPIA & VE welcome the ECs initiative to develop the Biotech Act II and supports the objective of strengthening Europes industrial biotechnology and biomanufacturing ecosystem. The Biotech Act II should primarily focus on improving framework conditions that enable advanced biomanufacturing and manufacturing innovation in Europe, helping to translate scientific excellence into commercial success.

Europes innovation ecosystem faces lack of capital, fragmentation, insufficient coordination, and regulatory complexity. For life sciences, these elements limit competitiveness and discourage investment. At the same time, Europe is losing global market share in R&D, clinical trials, and biomanufacturing, while talent continues to move abroad.

EFPIA welcomes the inclusion of EU-level targets in the Safe Hearts Plan and believes that the Council Recommendation (CR) should translate into even greater ambition at national level. CR should include a clear commitment that every person receives a comprehensive cardiometabolic risk assessment by age 35 (Know Your Numbers by 35), with regular reassessment thereafter.

EFPIA response to the Commission Call for Evidence on Chemicals – making best use of EU agencies to streamline scientific assessments The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. It is essential for EFPIA that any actions as part of the EU Chemicals Strategy for Sustainability (CSS), do not have a negative impact on ensuring the access of safe, efficient medicines and vaccines to citizens in Europe.

EFPIA welcomes the opportunity to comment on the draft Commission Implementing Act laying down the minimum metadata elements and their characteristics for dataset descriptions under the European Health Data Space (EHDS).

EFPIA welcomes the opportunity to comment on the draft Commission Implementing Act laying down the measures for the establishment and operation of the European Health Data Space (EHDS) Board. We support the Commissions efforts to develop a robust governance structure for the EHDS and recognise the importance of the Board in ensuring consistent implementation across Member States.

EFPIA, representing the biopharmaceutical industry operating in Europe, welcomes the opportunity to contribute to the European Commission's open consultation on the EU Access and Benefit-Sharing (ABS) Regulation (EU No 511/2014).

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the opportunity to submit feedback on the Foreign Subsidies Guidelines. The FSR aims to subject subsidies granted by non-EU countries to the same sort of scrutiny as applies to EU Member State subsidies under EU State aid rules.

On behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA), we welcome the opportunity to contribute to the call for evidence on past implementation of the Regulation concerning customs enforcement of intellectual property rights (Regulation (EU) No 608/2013) .

EFPIA welcomes the opportunity to contribute to the Call for Evidence regarding the Good Laboratory Practice (GLP) framework. From our perspective, the current GLP directive and the existing framework are functioning well and continue to support high-quality non-clinical studies across the EU. EFPIA finds that the GLP principles as defined by the OECD are both relevant and value-adding.

EFPIA supports the Commissions objective of preventing designer precursors from being used for the illicit manufacture of drugs and acknowledges the need for effective and proactive controls. At the same time, the proposed scheduling of 148 substances as Category 1 precursors should be implemented in a way that avoids unintended barriers to legitimate pharmaceutical research and development.