The European Medicines Agency (EMA) last week released a new concept paper for a future guideline on the clinical evaluation of therapeutic radiopharmaceuticals (tRPs) for treating cancer to address the growing number of requests for scientific advice for these products.
The proposed guideline will address regulatory and methodological aspects related to clinical trial design in the rapidly growing field of radiopharmaceuticals. It will cover implementing patient-specific dosimetry in clinical trials, which is not covered by current anticancer product guidelines.
EMA noted that radiopharmaceuticals are special types of medicinal products that are regulated by both the pharmaceutical legislation (2001/83/EC) and the radiation protection legislation (Directive 13 2013/59/Euratom). They are defined as a medicinal product which contains one or more radionuclides, radioactive isotopes, when ready for use…
