EMA webpage dedicated to the reform of the EU pharmaceutical legislation

19th January 2026

EMA webpage dedicated to the reform of the EU pharmaceutical legislation

Following EMA's communication last month regarding the landmark political agreement between the European Parliament and the Council of the European Union on the reform of the EU pharmaceutical legislation, they are pleased to announce that an EMA webpage dedicated to the implementation of this new legislation has now been published: Reform of the EU pharmaceutical legislation | European Medicines Agency (EMA)

This new pharmaceutical legislation represents the most significant overhaul of the regulatory framework in over two decades. It aims to modernise how medicines are developed, authorised, and made available to patients across the EU.

The newly launched webpage will serve as a central repository of information for all our stakeholders, providing up-to-date guidance and resources. It highlights the key benefits of the new pharmaceutical legislation and, once the new legislative text is adopted in 2026, it will offer detailed insights into the implementation process on specific technical and procedural aspects. The webpage will cover in particular the six activity areas overseen by EMA, namely:

• Centralised procedure and committees
• Development support
• Environmental risks
• Quality and manufacturing
• Shortages
• Regulatory and legal aspects

We encourage you to visit the new webpage regularly to stay informed about the progress.

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