欧盟理事会通过 Pharma Package，法规与指令仍待欧洲议会正式通过

The Council of the European Union has adopted the so-called Pharma Package, a new set of rules intended to increase patients' access to medicines and make the EU pharmaceutical sector fairer and more competitive. In December 2025, the EU co-legislators reached a provisional agreement to reform the EU's pharmaceutical legislation. The reform aims to strengthen competitiveness, innovation and security of supply, while improving the availability, accessibility and affordability of medicines. It also seeks to strengthen environmental standards and enhance the competitiveness of the EU pharmaceutical industry. Key elements include: regulatory protection; availability of medicines; the "Bolar exemption"; antimicrobial resistance; and orphan medicinal products.The reform also introduces changes relevant to GMP, including provisions on decentralised manufacturing, Qualified Person (QP) qualifications and expectations regarding shortages affecting MAIH (Manufacturing and Importation Authorisation Holder). The regulation and directive forming the Pharma Package must now be formally adopted by the European Parliament. They will then enter into force following their publication in the Official Journal of the European Union. The directive will subsequently need to be transposed into national law. Source: Council of the European Union press release