The reform of the pharmaceutical legislation replaces two‑decade‑old legislation with a framework that aims to expand access and availability of medicines through streamlined, science‑based authorisation procedures and faster evaluation at the European Medicines Agency. It includes measures to cut administrative ‘red tape’ for companies and reduce overall timelines so that new treatments, particularly for unmet needs, reach patients more quickly.
The new rules introduce incentives, regulatory sandboxes and tailored frameworks for novel and non‑standard products, with the explicit goal of placing the EU at the forefront of pharmaceutical innovation. They also strengthen the conditions for generic entry by clarifying the application of the Bolar exemption, and establish an EU framework to monitor and address medicine shortages through stronger coordination and a dedicated list of critical medicines.
According to the Commission, the package will underpin a more competitive and innovative healthcare sector and aligns with wider initiatives such as the Critical Medicines Act, the EU Life Sciences Strategy and the planned Biotech Act. The political agreement now moves to formal approval by the European Parliament and the Council before the new rules can apply.
Source: European Commission
Link: Commission welcomes political agreement on major reform of EU pharmaceutical rules
Date: 11 December 2025
