Clinical trials for medicines: non-investigational medicinal products

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), effective April 28, 2026, outlines the requirements for using Non-Investigational Medicinal Products (NIMPs) and non-medicinal products in clinical trials. It operates under the Medicines for Human Use (Clinical Trials) Regulations 2004 and its 2025 amendments, as well as the Human Medicines Regulations 2012. As this is a general regulatory framework document rather than an enforcement report, it does not list specific company names, inspection dates, or individual violations. NIMPs are defined as products used in a trial as described in the protocol—such as rescue medications, challenge agents, or background treatments—but which are not the primary investigational drugs. Sponsors are required to prioritize the use of authorized medicinal products; any use of unauthorized NIMPs must be explicitly justified in the trial protocol based on availability or specific formulation needs. Key actions for compliance include: 1. Submitting a quality dossier for all NIMPs within the clinical trial application. 2. Ensuring all products are manufactured according to Good Manufacturing Practice (GMP) standards. 3. Adhering to specific labelling requirements, which typically follow standard pharmacy rules for authorized products but require more detailed parameters for unauthorized or non-medicinal items. 4. Reporting all serious adverse events linked to these products and including them in periodic safety updates. Investigators must remain fully aware of these standards to maintain trial integrity and participant safety.