Political agreement on EU Pharmaceutical Legislation (Dec. 2025)

EANM welcomes political agreement on EU Pharmaceutical Legislation: A step forward for patient access and innovation

EANM welcomes the political agreement reached on December 11, 2025 on the revision of the EU Pharmaceutical Legislation, a landmark reform that will shape the future of medicines regulation across Europe. The agreement represents the most significant update to EU pharmaceutical rules in over 20 years, aiming to:

• Improve patient access to safe, effective, and affordable medicines across all Member States
• Foster innovation in areas of unmet medical need, including rare diseases and advanced therapies
• Strengthen supply chain resilience and reduce medicine shortages
• Accelerate regulatory pathways for breakthrough treatments while maintaining high safety standards

More information is available on the European Commission’s website.

The provisional agreement has not yet been made publicly available. Once published, EANM will thoroughly review both the regulation and the directive and promptly share clear, detailed information with the nuclear medicine community on the regulatory changes affecting radiopharmaceuticals.

The resulting compromise, i.e., provisional agreement will now need to be approved by the European Parliament, at the Committee and plenary levels, and the Member State Ambassadors and Ministers of the Council resulting in an early second-reading agreement. Once adopted, the Directive would then be published in the EU Official Journal before entering into force.

The revision of the EU Pharmaceutical Legislation is a welcome step toward improving patient care, yet it reflects the compromises of a complex political process. EANM remains committed to playing an active role in the next phase: supporting effective implementation and contributing to broader pharmaceutical policy discussions. Our focus will be on ensuring fair and timely access to radiopharmaceuticals, reinforcing health resilience, and collaborating with healthcare systems and partners to advance nuclear medicine as an essential pillar of public health across Europe.

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Published online: December 15, 2025.