MHRA publishes guidance on GMP and radiopharmaceutical investigational medicines in clinical trials

11th March 2026

Summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on good manufacturing practice (GMP) and the use of radiopharmaceutical investigational medicinal products (IMPs) in clinical trials. The document supports the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the 2025 regulations, which will come into force on 28th April 2026. It clarifies expectations for sponsors, investigators and manufacturing sites involved in the preparation, labelling and handling of IMPs, including those containing radioactive substances used for diagnostic or therapeutic purposes. The guidance also explains how UK GMP requirements relate to existing EU standards and outlines specific controls and processes for radiopharmaceutical products used in trials. Feedback on the draft guidance is open until 25th March 2026.

Link: https://www.gov.uk/guidance/clinical-trials-for-medicines-good-manufacturing-practice-and-radiopharmaceutical-investigational-medicinal-products

 

 

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