Political Agreement Reached on the EU Pharmaceutical Reform Package

Authorisation and innovation

According to the Commission's factsheet on the key elements, the European Medicines Agency (EMA) will be given a more streamlined structure, and its evaluations will be shortened from 210 days to 180 days. Digital tools such as online submissions and electronic product leaflets will be introduced. The reform introduces regulatory sandboxes to test genuinely novel approaches, adapted frameworks for certain non-standard treatments such as personalised therapies, and the possibility of decentralised manufacturing at the patient's bedside.

Incentives are aimed at unmet medical needs, rare diseases and children. To tackle antimicrobial resistance, the package includes a voucher scheme for novel antibiotics, and the factsheet describes an additional year of regulatory protection for companies that deliver functioning innovative therapies against multi-drug resistant infections. The Commission estimates that simplification measures will save public authorities and businesses €300 million a year.

Generics and shortages

The reform aims to allow day-one market entry for generic and biosimilar medicines once protection periods end, including clarification of how the Bolar exemption applies. On supply, companies will face stronger obligations to prevent shortages, the EMA will have a stronger coordinating role in critical shortages, and an EU list of critical medicines will be established alongside assessments of supply chain vulnerabilities.

What happens next

The political agreement must now be formally approved by the European Parliament and the Council before the new directive and regulation are adopted and published. The reform sits alongside the proposed Critical Medicines Act, the Life Sciences Strategy, a forthcoming Biotech Act and a targeted revision of the medical devices rules. Originator companies, generic manufacturers and investors in EU life sciences will need to reassess product lifecycle and launch planning once the final texts are available.

Sources

• European Commission press corner: Commission welcomes political agreement on major reform of EU pharmaceutical rules
• European Commission: Factsheet, key elements of the EU pharmaceutical reform