Consultation participation and their own register declarations, side by side. Counts, not judgments — participation is not influence.
Counts here are a floor, never a total: they cover the 583 consultation files tracked so far (42,224 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
Register facts self-declared (snapshot 2 Sept 2026); cost bands are floors. Shared files are shared attention, not evidence of coordination.
What each said, in their own words
Their opening passages on the files they share, verbatim and in filing order. We do not summarize, compare, or characterize positions — read them at source.
EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.
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
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.
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.
Revision of the Blood, Tissues & Cells (BTC) Legislation offers an important opportunity to ensure regulatory standards safeguarding patient safety and public health keep pace with technical and scientific advances, legal certainty and risk-based flexibility to facilitate innovation, and sustainability of supplies across EU for both therapeutic need and producing products derived from BTC.
EFS fully supports the comments provided by the French Ministry of Health. The additional comments presented aim to address in more detail specific issues we identified in our areas of expertise. EFS does not agree with the statement “the lack of […] national monitoring provisions for the supply of BTC makes it difficult to predict EU supply interruptions and to take action to mitigate the risks to patients” when it…
The proposed Substances of Human Origin(SoHO) Regulation intends to harmonize measures for Member States and organizations involved in activities related to SoHOs for human application, facilitating cross-border exchange and continuity of supply in the EU. EFPIA supports these aims but is concerned about areas of the SoHO Regulation that appear incoherent with medicinal product regulation.
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