UK MHRA Guidance on Clinical Trials: Labelling, Non-Investigational Medicinal Products, Trial Modifications, IVD Use, and Expert Advice
- Sharan Murugan
- 2 hours ago
- 3 min read
Clinical trials play a critical role in evaluating the safety and effectiveness of medicines before they are made available to patients. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance to help sponsors and researchers comply with regulatory requirements for clinical trials involving medicinal products.
This article provides a consolidated overview of MHRA guidance covering several key areas of clinical trial regulation, including labelling of investigational medicines, use of non-investigational medicinal products (NIMPs), modification of approved trials, trials involving in vitro diagnostic devices (IVDs), and access to expert regulatory advice.
Labelling of investigational medicinal products (IMPs) is an important regulatory requirement in clinical trials. Proper labelling ensures that investigational products are correctly identified, handled safely, and administered appropriately during a clinical study.
The label must provide essential information that supports safe use of the medicine within the trial. This typically includes identification of the clinical trial, product details, storage instructions, expiry date, and a statement indicating that the medicine is for clinical trial use.
In certain cases, simplified labelling requirements may apply, particularly when authorised medicines are used according to their existing marketing authorisation. The MHRA guidance explains these requirements to help sponsors ensure that investigational products are labelled in a manner that protects trial participants and supports proper study conduct.
Non-Investigational Medicinal Products (NIMPs) are medicines used during a clinical trial that are not the investigational product being studied but are necessary for the proper conduct of the trial.
Examples of NIMPs include background therapies, rescue medications, or medicines used to manage conditions related to the study treatment. Even though they are not the primary investigational medicine, they may influence the results of the trial and must therefore be properly managed.
The MHRA guidance explains how sponsors should ensure that NIMPs meet appropriate quality standards and are clearly described in the clinical trial protocol. Where possible, authorised medicines should be used, and their use should align with their approved indications. Sponsors must also evaluate the role of NIMPs in the study design to ensure they do not introduce additional risks to participants or affect the reliability of the study data.
After a clinical trial has been approved, sponsors may need to make changes to the protocol or other aspects of the trial. The MHRA guidance explains how such modifications should be managed. Changes to approved trials are generally classified as substantial amendments or non-substantial amendments.
Substantial amendments are significant changes that may affect participant safety, the scientific value of the trial, or the conduct of the study. These changes require approval from the MHRA and the relevant research ethics committee before they are implemented.
Non-substantial amendments are minor administrative changes that do not significantly affect the safety or integrity of the trial. Although they do not require prior approval, they should still be documented by the sponsor. This process ensures that any important changes to the trial are reviewed and approved before implementation.
Some clinical trials involving medicines also include the use of in vitro diagnostic devices (IVDs). These devices are used to analyse biological samples and may help identify eligible participants, monitor biomarkers, or support personalised treatment strategies. The MHRA guidance explains the regulatory considerations when IVDs are used as part of a clinical trial. Sponsors must ensure that these devices comply with applicable medical device regulations and are appropriate for their intended use in the study.
Depending on how the device is used, additional regulatory approvals or requirements may apply. Proper validation and regulatory compliance are necessary to ensure that the use of the diagnostic device does not compromise participant safety or the reliability of trial results.
The MHRA offers an expert advice service that allows sponsors and developers to seek regulatory guidance during the planning and development of clinical trials. This service helps sponsors design studies that align with regulatory expectations and avoid potential issues during trial approval. Sponsors can obtain advice on topics such as clinical trial design, regulatory requirements, safety considerations, and development strategies.
Engaging with regulatory experts early in the development process can improve the efficiency of clinical trial planning and support smoother regulatory interactions.
Conclusion
MHRA guidance provides an important framework for conducting safe and compliant clinical trials in the UK.
By following these guidelines, sponsors can ensure that clinical trials maintain high standards of safety, regulatory compliance, and scientific integrity while supporting the development of new medicines.
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