EMA welcomes political agreement on new EU pharmaceutical legislation

15th December 2025

EMA welcomes political agreement on new EU pharmaceutical legislation

Summary: The EMA has praised a political agreement reached by the European Commission, the European Parliament and the Council of the European Union to modernise the EU’s pharmaceutical regulatory framework, marking a “historic milestone” for medicines regulation and EU patients. The reform aims to simplify regulatory procedures, strengthen patient access to safe and effective treatments, and enhance the EMA’s agility and scientific rigour. Key elements include streamlining the agency’s scientific committee structure (reducing from five to two committees), embracing digitalisation of submissions and assessments, and improving support for innovation — including frameworks for novel therapies and expanded scientific advice. The new legislation is also designed to help address major public health challenges such as antimicrobial resistance, medicines shortages and emerging threats. The political agreement must now be formally approved by the European Parliament and Council before becoming law.

Link: EMA welcomes political agreement on new EU pharmaceutical legislation

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