EU Pharma Package: EMA with single Point of Information

The European Medicines Agency EMA has created a webpage dedicated to the implementation of the reform of the EU pharmaceutical legislation. 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 EMA's 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

EMA will provide details on these activity areas following the adoption of the new legislative text in 2026.