EMA welcomes the political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the reform of the EU pharmaceutical legislation, which will mark the most significant reform of the regulatory framework in the EU in over two decades. The reform was proposed by the European Commission in April 2023 and adopted by the European Parliament and by the Council of the EU in April 2024 and June 2025, respectively.
This new legislation will modernise how medicines are developed, authorised, and made available to patients across the EU and will simplify structures and procedures introduced by different pieces of legislation including:
- Regulation 726/2004 and Directive 2001/83/EC - Pharmaceutical
- Regulation 1901/2006 and Regulation 141/2000/EC - Medicines for Children and Rare Diseases
- Regulation 1394/2007 - Advanced Therapy Medicinal Products (ATMP)
A few key areas will be affected by this reform:
- A simpler regulatory environment, including the simplification of the structure of EMA's scientific committee for human medicines from five to two scientific committees (the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC)), the streamlined process that will facilitate the reduction of assessment time from 210 to 180 days, the unlimited validity period for medicine marketing authorisation, and electronic and structured formats for submitting the marketing authorisation application.
- More support and improved conditions for innovation, including extended scientific advice to HTA bodies, the establishment of a regulatory sandbox in consultation with Member States, the creation of adapted frameworks for certain non-standard medicine categories such as personalised therapies, and the improved process for studying medicines in children
- Stronger safeguards against medicine shortages, including the companies' obligations to ensure continuous supply of medicines and notify shortages and withdrawals, the commitment to monitor shortages in collaboration with national competent authorities, and the establishment of EU list of critical medicines.
- Enhanced environmental protection and focus on antimicrobial resistance, including strengthened provisions on environmental risk assessment and prudent use of antimicrobials
The political agreement is now subject to formal approval by the European Parliament and the Council. Once approved, EMA will work together with the European Commission and EU Member States, to develop relevant guidance for applicants and marketing authorisation holders to comply with the new legal framework.
Disclaimer:
This article was adapted and simplified for the reader from its original resource. Please refer to the original resource for further information.
Source:
- EMA welcomes political agreement on new EU pharmaceutical legislation: https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation
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