Guidance

Clinical trials for medicines: Diagnostic Radiopharmaceutical Investigation Medicinal Products and Good Manufacturing Practice requirements

Further explanatory guidance for Diagnostic Radiopharmaceutical (RP) Investigation Medicinal Products (IMPs) and Good Manufacturing Practice (GMP) requirements.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 28 April 2026

Documents

Clinical trials for medicines: Diagnostic Radiopharmaceutical Investigation Medicinal Products and Good Manufacturing Practice requirements

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This document clarifies the basis of the requirements defined in the “Clinical trials for medicines: Good Manufacturing Practice and Radiopharmaceutical Investigational Medicinal Products Guidance” (“GMP and RP guidance”) document, published via the clinical trials hub.

Published 28 April 2026