EU Pharma Reform Deal Sealed

In a significant development dated 11 December 2025, the European Parliament announced a provisional agreement on the extensive reform of EU pharmaceutical legislation, aimed at enhancing innovation, competitiveness, and the availability of medicines across the European Union.

The agreement, reached early Thursday morning, outlines several key reforms including the introduction of an extended period of regulatory data protection, efforts to combat antimicrobial resistance, and structural optimizations within the European Medicines Agency (EMA). These measures are designed to streamline regulatory processes and improve the management of medicinal shortages, thus ensuring a more robust supply chain across the member states.

Under the new framework, pharmaceutical companies will receive extended market protection for products meeting specific criteria, such as addressing unmet medical needs or incorporating new active substances. The reform package also introduces a “transferable data exclusivity voucher” for priority antimicrobials, which extends data protection by 12 months, aiming to foster innovation in tackling antimicrobial resistance. This includes stricter regulations on antimicrobial prescriptions and mandatory antimicrobial stewardship plans from companies seeking marketing authorizations.

Furthermore, the restructuring of the EMA is set to expedite the handling of market authorization applications, which will now be submitted electronically and, by default, granted for an unlimited duration unless specified otherwise. The European Commission may also establish regulatory sandboxes to test and develop innovative therapies under close supervision.

This legislative milestone follows the European Commission’s proposal from April 2023 to overhaul the EU’s pharmaceutical laws, enhancing accessibility, affordability, and environmental standards of medicines. The next steps involve formal adoption by the Council and subsequent endorsement by the Parliament in a second reading.

Accompanying this announcement, a press conference is scheduled for 9:30 CET on 11 December at the Parliament’s Anna Politkovskaya press conference room in Brussels. Statements from significant parliamentary figures and additional details on the agreement are accessible online, providing comprehensive insights into the future of Europe’s pharmaceutical landscape.