The European Medicines Agency (EMA) has welcomed the 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. This represents the most significant update to the EU medicines regulatory framework in over 20 years and a once-in-a-generation opportunity to modernize medicines regulation across Europe.
The reform will enable EMA and the European medicines regulatory network to operate more efficiently and flexibly while maintaining high scientific standards. By simplifying procedures, advancing digitalization, and optimizing scientific resources, the new framework aims to accelerate patient access to innovative treatments and strengthen Europe’s readiness to address major public health challenges, including antimicrobial resistance and emerging health threats.
The legislation modernizes how medicines are developed, authorized, and made available across the EU. It streamlines and consolidates existing pharmaceutical laws, including those governing human medicines, pediatric and orphan drugs, and advanced therapy medicinal products (ATMPs). Some of the Key Changes that took place was:
Simpler Regulation and Faster Reviews: EMA’s committee structure will be streamlined from five to two scientific committees for human medicines: the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), supported by broader expert, patient, and healthcare professional input. Assessment timelines will be reduced from 210 to 180 days, and marketing authorizations will be granted for an unlimited duration by default unless safety concerns arise. The reform also mandates fully electronic submissions and digital product information (ePI).
Stronger Support for Innovation: The legislation strengthens innovation support through extended scientific advice with health technology assessment bodies, enhanced PRIME support, and the potential establishment of regulatory sandboxes to test adapted requirements for breakthrough medicines. It also introduces tailored frameworks for non-standard and personalized therapies and improves efficiency in pediatric medicine development through formalized iterative Pediatric Investigation Plans.
Improved Medicine Supply Security: New obligations will require companies to ensure continuous medicine supply, notify shortages and withdrawals in advance, and implement shortage prevention plans. EMA and national authorities will jointly monitor shortages, supported by a new EU list of critical medicines subject to supply chain vulnerability assessments.
Environmental Protection and Antimicrobial Stewardship: The reform strengthens environmental risk assessments, including evaluating antimicrobial resistance risks from manufacturing. It also reinforces the prudent use of antimicrobials through mandatory prescriptions, enhanced patient information, awareness tools, and antimicrobial stewardship plans.
The agreement now awaits formal approval by the European Parliament and the Council. Following adoption, EMA will work with the European Commission and Member States to develop guidance and ensure smooth implementation, supported by a dedicated information hub for stakeholders.
Learn more: EMA welcomes political agreement on new EU pharmaceutical legislation
