MHRA Updates Labelling Requirements for Investigational Medicinal Products (IMPs) in Clinical Trials

10th October 2025

MHRA Updates Labelling Requirements for Investigational Medicinal Products (IMPs) in Clinical Trials

Summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has published a revised version of its labelling requirements for Investigational Medicinal Products (IMPs) used in clinical trials. The updated guidance, effective from 1st October 2025, introduces a decision tree to assist sponsors in determining the minimum labelling requirements based on the IMP's authorisation status, intended use, and administration setting. Key updates include:

• Point-of-Care (POC) IMPs: No labelling is required if the IMP is administered in its entirety immediately after manufacture.

• Radiopharmaceuticals: Specific labelling requirements apply for IMPs used for diagnostic purposes.

• UK-Authorised IMPs: If the IMP has a UK marketing authorisation or Article 126a authorisation and is unmodified, labelling should comply with regulation 46(4) of the Clinical Trials Regulations. If not unmodified, full labelling according to regulation 46(1) is required.

• Hospital or Health Centre Use: For IMPs used exclusively within a hospital or health centre participating in the trial, labelling should adhere to Part 13 of the Human Medicines Regulations 2012, with additional information as specified in the guidance.

• EU or ICH-Authorised IMPs: If the IMP is authorised in the EU or an ICH region and is unmodified, full labelling according to regulation 46(1) of the Clinical Trials Regulations is necessary.

These updates aim to streamline labelling practices and ensure compliance with regulatory standards, facilitating the conduct of clinical trials in the UK.

Link: Labelling Requirements for IMPs in Clinical Trials – MHRA

Back to Recent News