EMA’s recommendations (April 2025)

EMA’s Recommendations to Address Vulnerabilities in the Supply Chain of Radiopharmaceuticals

The European Medicine Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), issued recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals. EANM welcomes the publication of this document as these recommendations have the potential to increase the EU’s domestic capabilities on radiopharmaceuticals production, ultimately mitigating the impact of shortages on patients.

The recommendations are directed to European and national authorities, as well as to industry with the aim to align efforts to address these issues.

Recommendations to the European Commission

EMA invites the European Commission to consider the MSSG’s findings on radioisotope supply vulnerabilities and explore measures to boost EU manufacturing and reduce reliance on third countries. This includes supporting EU-based HALEU capacity, advancing the European Radioisotopes Valley Initiative (ERVI), addressing transport challenges, and expanding monitoring to other key isotopes beyond Mo-99/Tc-99m.

Recommendations to Member States

EMA invites Member States to assess national supply chains, support regulation, and address transport issues in line with EU efforts. They are also invited to include new radiopharmaceuticals in horizon scanning.

Recommendations to EMA

The published document is also encouraging EMA to offer regulatory support, assist Member States with horizon scanning, and coordinate related activities to ensure efficiency and avoid duplication of efforts.

Recommendations to the industry

Companies are invited to cooperate fully and share relevant information to help secure the EU supply of medical radioisotopes.

EANM’s response

The EANM welcomes EMA’s recent publication and is pleased to see such a political commitment to the supply of medical radioisotopes at the highest level. As the demand for radiopharmaceuticals grows, ensuring their consistent availability is paramount for patient care across Europe.

EANM has consistently highlighted the unique challenges associated with radiopharmaceuticals, including their short half-lives, reliance on specialized infrastructure, and the necessity for on-site preparation in many clinical settings. We are encouraged to see these specificities acknowledged in the EMA’s recommendations. Harmonised regulatory standards across EU Member States and streamlined procedures to facilitate the authorisation and distribution of radiopharmaceuticals should accompany these efforts.

The emphasis on increasing domestic production capacity, addressing transport challenges through harmonization, and fostering collaboration between regulators and industry aligns with EANM’s longstanding vision. Notably, the call to consider the inclusion of new radiopharmaceuticals in horizon scanning activities is a proactive step towards anticipating future needs.

EANM emphasises the importance of a robust supply chain infrastructure, aligning with the call for enhanced communication among all stakeholders, including healthcare professionals, wholesalers, manufacturers, and national competent authorities. Timely and transparent information exchange is crucial to minimize patient impact during shortages.

EANM calls the European Commission to act promptly to complete the European Radioisotopes Valley Initiative which has the potential to secure the supply of medical radioisotopes. Similarly, the expanding the mandate of the European Observatory of medical radioisotopes to other key isotopes beyond Mo-99/Tc-99m is a key tool.

EANM remains committed to collaborating with European and national authorities, as well as industry stakeholders, to implement these recommendations effectively. By working together, we can enhance the resilience of the radiopharmaceutical supply chain, ensuring that patients across Europe have timely access to essential diagnostic and therapeutic tools.

Read the recommendations

Published online: April 15, 2025