Meeting with Olga Solomon (Head of Unit Health and Food Safety) and 10 other interest representatives

3 Oct 2025 · The discussion focused on simplifying Annex II to foster innovation while aligning with ICH guidelines, with ideas for legacy products to gradually transition.

Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur for opinion)

17 Sept 2025 · CMA

Response to Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

4 Jul 2025

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

22 May 2025 · to follow

Response to Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Strategy to support medical countermeasures against public health threats

8 May 2025

Response to Communication on the EU Stockpiling Strategy

8 May 2025

Response to Critical Medicines Act

26 Feb 2025

Response to COMMISSION DELEGATED REGULATION (EU) …/... amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use

29 Feb 2024

Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur)

31 Jan 2024 · SoHOs

Response to 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) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

29 Oct 2023

Response to 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

29 Oct 2023

Response to Commission Delegated Regulation supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council on the examination of variations to the terms of marketing authorisations for medicinal products for human use and amending Commission Regulation (EC) No 1234/2008 of 24 November 2008

26 Sept 2023

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

17 Jul 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

12 Jul 2023 · SoHO

Meeting with Tiemo Wölken (Member of the European Parliament)

20 Feb 2023 · Verordnung über Qualitäts- und Sicherheitsstandards für zur Verwendung beim Menschen bestimmte Substanzen menschlichen Ursprungs (staff level)

Meeting with Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis) and Takeda Pharmaceuticals International AG

20 Jan 2023 · EU-US Mutual Recognition Agreement on Pharmaceutical Good Manufacturing Practices

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur) and Grifols, S.A.

12 Oct 2022 · SoHO regulation

Meeting with Romana Jerković (Member of the European Parliament)

5 Oct 2022 · Substances of human origin

Response to Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

7 Sept 2022

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides), Ralf Kuhne (Cabinet of Commissioner Stella Kyriakides)

17 Mar 2022 · VTC Meeting on Blood, Tissues and Cells legislation and availability of Plasma-Derived Medicinal Products

Response to Evaluation and Revision of Regulation (EC) No 726/2004 and Directive 2001/83/EC

26 Apr 2021

Meeting with Margaritis Schinas (Vice-President) and 21 other attendees

8 Apr 2021 · Health Union

Response to Proposal for an EP and Council Regulation on orphan and paediatric medicinal products

6 Jan 2021

Response to Revision of Directive 2002/98/EC on safety and quality of human blood and blood components and of Directive 2004/23/EC on safety and quality of human tissues and cells and their implementing acts.

14 Dec 2020

Response to Commission Communication on a Pharmaceutical Strategy- Ensuring sustainable innovation and the availability and affordability of medicines and medical technologies for citizens

6 Jul 2020

Meeting with Vytenis Andriukaitis (Commissioner) and 10 other attendees

15 Jun 2018 · HTA

Response to Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

8 Jan 2018

Response to COMMISSION REGULATION (EU) No …/.. amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

13 Oct 2016