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Position statement on radiopharmaceutical production for clinical trials
EJNMMI Radiopharmacy and Chemistry
|March 6, 2018
Summary
EU Regulation 536/2014 facilitates diagnostic radiopharmaceutical use but faces national restrictions hindering its application. Full implementation requires addressing these conflicts and considering therapeutic radiopharmaceuticals for nuclear medicine advancement.
Area of Science:
- Nuclear Medicine
- Radiopharmaceutical Research
- EU Regulatory Affairs
Background:
- EU Regulation 536/2014 governs the use of diagnostic radiopharmaceuticals.
- Good Manufacturing Practice (GMP) requirements are a key focus of the regulation.
- Implementation across EU countries is mandated.
Purpose of the Study:
- To assess the current application status of EU Regulation 536/2014.
- To identify barriers to the regulation's full implementation.
- To propose recommendations for advancing nuclear medicine.
Main Methods:
- Survey of current practices and regulatory adherence.
- Analysis of national restrictions conflicting with EU Regulation 536/2014.
- Review of regulatory frameworks for radiopharmaceutical use.
Main Results:
- Significant discrepancies exist between the EU regulation and national implementations.
- National restrictions impede the seamless experimental use of diagnostic radiopharmaceuticals.
- Nuclear medicine centers face challenges in regulatory compliance due to conflicting national rules.
Conclusions:
- Full application of EU Regulation 536/2014 is not yet achieved due to national restrictions.
- National authorities must actively work towards harmonizing regulations.
- Updating the regulation to include therapeutic radiopharmaceuticals is recommended for nuclear medicine's progress.
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