Critical Medicines Act - Related links

European Commission & Joint Research Centre

Most recent publications

• Critical Medicines Act – 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 – European Commission Proposal for a Regulation (11 March 2025)
• Critical Medicines Act – European Commission Factsheet (11 March 2025)
• EU Actions to address medicine shortages, boost Europe's production and improve security of supply for critical medicines – European Commission Factsheet (March 2025)
• Mission letter to Commissioner for Health and Animal Welfare Olivér Várhelyi – European Commission (17 September 2024)
• The European Health Union: acting together for people's health – European Commission Communication (22 May 2024)
• A Critical Medicines Alliance for Europe – European Commission Factsheet (24 April 2024)
• Health Emergency Preparedness and Response Authority (HERA) Work Plan – European Commission Work Plan (2024)

Communications

• Addressing medicine shortages in the EU – European Commission Communication (24 October 2023)
• Reform of the pharmaceutical legislation and measures addressing antimicrobial resistance – European Commission Communication (26 April 2023)
• EU Global Health Strategy – European Commission Communication (30 November 2022)
• Introducing HERA, the European Health Emergency preparedness and Response Authority, the next step towards completing the European Health Union – European Commission Communication (16 September 2021)
• Pharmaceutical Strategy for Europe – European Commission Communication (25 November 2020)
• Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats – European Commission Communication (11 November 2020)

Proposals

• Pharmaceutical Regulation – European Commission Proposal for a Regulation (26 April 2023)
• Pharmaceutical Directive – European Commission Proposal for a Directive (26 April 2023)
• Extend the mandate of the European Centre for Disease Prevention and Control – European Commission Proposal for a Regulation (11 November 2020)

Other

• A Pharmaceutical strategy for Europe – European Commission Webpage (2023)
• Impact assessment report accompanying the revision of the general pharmaceutical legislation – DG for Health and Food Safety (April 2023)
• Speech by Commissioner Stella Kyriakides at EP Plenary Session on Medicine Shortages and Strategic Healthcare Autonomy – European Commission Press Release (3 October 2023)
• Study on best practices in the public procurement of medicines – European Health and Digital Executive Agency Report (December 2022)
• Future-proofing pharmaceutical legislation: study on medicine shortages – European Commission Report (January 2022)

Joint Research Centre

• Bio-based value chains for chemicals, plastics and pharmaceuticals – JRC Report (2021)

• Access and Cost of Education and Health Services – JRC Report (2021)

• Artificial Intelligence in Medicine and Healthcare: applications, availability and societal impact – JRC Report (2020)

• Reassessing the Decline of EU Manufacturing: A Global Value Chain Analysis – JRC Report (2019)

European Parliament and Council of the European Union

Legislation

• Reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices – Regulation (EU) 2022/123 of the European Parliament and of the Council (25 January 2022)

• Health technology assessment – Regulation (EU) 2021/2282 of the European Parliament and of the Council (15 December 2021)

European Parliament

• Revision of EU pharmaceutical legislation – European Parliament Research Services (May 2024)

• Building up resilience to cross-border health threats – European Parliament Research Services (February 2023)

• Towards a new EU pharmaceutical strategy – European Parliament Research Services (December 2022)

• Addressing shortages of medicines – European Parliament Research Services (April 2020)

Council of the European Union

• EU health policy – Council of the European Union Info Page (2024)

• The EU's response to the COVID-19 pandemic – Council of the European Union Info Page (2024)

• European Health Union: protecting Europeans against cross-border health threats – Council of the European Union Info Page (2024)

• Health technology assessment – Council of the European Union Info Page (2024)

• Open strategic autonomy in the area of health: Measures to develop a solid pharmaceutical ecosystem – Council of the European Union Background Note (10 November 2023)

Additional Articles, Studies and Reports

• Ambitious Critical Medicines Act vital to secure supply – Medicines for Europe Press Release (11 March 2025) [position paper here]

• Response to the Critical Medicines Act - European Federation of Pharmaceuticals Industries and Associations (11 March 2025)

• Statement on the European Commission's proposal for the Critical Medicines Act – European Patients Forum (March 2025)

• Good Manufacturing and Distribution Practices – European Federation of Pharmaceuticals Industries and Associations (EFPIA) (March 2025)

• Delivering a healthier, more competitive and secure Europe – EFPIA (January 2025)

• Medicine Shortages : EFPIA Proposal for Action – EFPIA (December 2024)

• White Paper on Circular Economy – EFPIA (May 2024)

• Much More than a Market (Chapter on Health Sector) – Enrico Letta's Report on the Future of the Single Market (17 April 2024)

• Global Trends to 2040: Choosing Europe's Future – European Strategy and Policy Analysis System (ESPAS) Global Trends Report (April 2024)

• Securing Medical Supply Chains in a Post-Pandemic World – OECD Report (February 2024)

• The European Medicines Agency’s contribution to science, medicines and health in 2023 – EMA Annual Report (2024)

• The Pharmaceutical Industry in Figures – EFPIA (2024)

• Pharmaceutical industry in Europe: Statistics & Facts – Statista Info Page (2024)

• European Medicine Agencies Network Strategy to 2025 – EMA & Heads of Medicines Agencies Report (December 2023)

• EII Health Annual Report – European Institute of Innovation and Technology (2023)

• Health at a Glance (Chapter 9 on Pharmaceutical Sector) – OECD Report (November 2023)

• A value-based approach to pricing – EFPIA (April 2023)

European Committee of the Regions

• CDR-5498-2023 - Addressing medicine shortages; Rapporteur: Erika Von Kalben (2024)

• CDR-5487-2020 – European Health Union: Reinforcing the EU's resilience; Rapporteur: Roberto Ciambetti (2021)