Diagnostic radiopharmaceutical IMPs and GMP requirements

28th April 2026

Summary:
This guidance outlines the Good Manufacturing Practice (GMP) requirements for diagnostic radiopharmaceutical investigational medicinal products (IMPs) used in clinical trials. It explains how these products, often prepared and used within short timeframes, can follow a risk-proportionate approach while still meeting appropriate quality and safety standards. The document provides clarity on manufacturing, control, and documentation expectations, helping sponsors and manufacturers ensure compliance without creating unnecessary burden. It supports consistent interpretation of GMP requirements across the UK clinical trials landscape.

Link: https://www.gov.uk/government/publications/clinical-trials-for-medicines-diagnostic-radiopharmaceutical-investigation-medicinal-products-and-good-manufacturing-practice-requirements

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