The European Medicines Agency (EMA) has welcomed a landmark political agreement reached by the European Commission, the European Parliament, and the Council of the European Union on the comprehensive reform of EU pharmaceutical legislation. 

 

The changes mark the most significant overhaul of the regulatory framework in over two decades.

 

“This represents a once-in-a-generation opportunity to reshape medicines regulation in the EU,” said EMA Executive Director Emer Cooke.

 

The reform is set to modernise how medicines are developed, authorised, and made available across the EU. EMA says it will allow the agency and the European medicines regulatory network to become more agile and efficient while maintaining the highest scientific standards.

 

“By simplifying procedures, embracing digitalisation and rationalising our use of scientific resources, we will be better positioned to support innovation and ensure that promising new treatments reach patients faster,” Cooke said. 

 

“The new legislation also provides us with the tools to deliver on our network strategy to 2028 and address the major public health challenges of the future, from antimicrobial resistance to emerging health threats.”

 

The reform introduces sweeping changes across EMA’s operations. Among them is simpler regulatory environment: EMA will reduce its committee structure from five to two—CHMP and PRAC—streamlining assessments from 210 to 180 days and freeing resources for pre-authorisation support. Marketing authorisations will be valid indefinitely by default, with digital submissions and e-product information becoming mandatory.

 

Stronger support for innovation is another change. The legislation allows EMA to offer extended scientific advice, establish regulatory sandboxes for experimental therapies, and create adapted frameworks for personalised medicines. It also formalises iterative paediatric investigation plans for medicines for children.

 

Under tougher safeguards against shortages,  companies will face stronger obligations to ensure continuous supply, notify shortages in advance, and cooperate with authorities. EMA and national agencies will monitor shortages and compile an EU list of critical medicines.

 

Environmental and antimicrobial protections strengthen environmental risk assessments, especially for antimicrobial resistance, and enforces prudent use of antimicrobials with compulsory prescriptions, stewardship plans, and detailed patient information.

 

“The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU,” Cooke said, noting it will consolidate decades of fragmented rules, including regulations on rare diseases, children’s medicines, and advanced therapies.

 

The political agreement now awaits formal approval by the European Parliament and Council. Once ratified, EMA will work with EU member states and the European Commission to provide guidance for applicants and ensure smooth implementation of the new legal framework.