Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance following the full implementation of the amended Clinical Trials Regulations on April 28, 2026. This framework, specifically the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, sets out standards for Good Manufacturing Practice (GMP) for Investigational Medicinal Products (IMPs) in the UK. A central update is Regulation 37A, which allows facilities holding a 'Manufacturer’s Specials' (MS) or standard manufacturing license to produce diagnostic radiopharmaceutical IMPs, a task previously limited to specialized MIA(IMP) sites. However, this exemption does not apply to therapeutic radiopharmaceuticals, which must still be manufactured at MIA(IMP) facilities. To maintain compliance, sponsors must list both the radiolabelling site and the facility responsible for final certification in their clinical trial applications. Furthermore, technical agreements must be established between all parties to define quality oversight. The guidance emphasizes that a Qualified Person (QP) remains responsible for batch certification and release. Organizations are also required to update labelling processes to meet 2025 standards, ensuring that MS license numbers are not included on IMP labels to avoid confusion with unlicensed medicines.