EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals
In their „Horizon Scanning Report“, EMA and HMA have recommended updates to the regulatory framework to keep pace with developments in radiopharmaceuticals. Due to their unique characteristics these products require specific regulatory and scientific approaches.
A key challenge is the fragmentation between pharmaceutical and radiation protection legislation, which requires better alignment, including on terminology and dosimetry requirements. Closer collaboration with radiation protection authorities and the potential creation of an EU-wide working group are recommended.
Another major issue is the lack of harmonisation across Member States, particularly in small-scale production, leading to variable GMP compliance. Authorities therefore highlight the need for harmonisation, updated guidance, and new guidelines, especially for diagnostic radiopharmaceuticals.
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