- The UK government has published updated guidance for applying for clinical trial approval under the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. These updated requirements will come into force on 28 April 2026.
- Under the revised regulations, investigators, sponsors, and any organizations delegated with trial-related responsibilities must have regard to all relevant guidance when commencing and conducting a clinical trial.
What Is Considered a Clinical Trial?
- According to Regulation 2 of the Clinical Trials Regulations, a clinical trial is any investigation in human participants — other than a non-interventional study — intended to:
- Discover or verify the clinical or pharmacological effects of medicinal products;
- Identify adverse reactions;
- Study absorption, distribution, metabolism, and excretion (ADME) of medicinal products.
Approval Required Before Starting a Clinical Trial
- Under Regulation 12, a clinical trial cannot begin without joint clinical trial approval, which includes:
- A favourable opinion from a Research Ethics Committee (REC);
- Authorization from the Medicines and Healthcare products Regulatory Agency (MHRA).
Single Combined Application Process
- Applications must be submitted through the Integrated Research Application System (IRAS) using a combined review process, where both the MHRA and ethics committee review the application in parallel.
Key Timelines
- Validation checks: Completed within 7 calendar days of submission;
- Initial review decision: Issued within 30 calendar days after validation;
- Requests for further information: Sponsors have 60 calendar days to respond through IRAS;
- Reconsideration decision: Issued within 10 calendar days after submission of additional information.
For applications involving consultation with specialist groups or advanced therapy medicinal products (ATMPs), review timelines may extend up to 120 calendar days.
Approval With Conditions
- If approval is granted with conditions, sponsors must fulfill all specified requirements before the clinical trial can proceed. The trial is considered approved only once all conditions are satisfied.
Appeals Process
- Under Schedule 5 of the Clinical Trials Regulations, applicants may appeal decisions through the Commission on Human Medicines (CHM). Sponsors are generally given 6 months to provide written or oral representations and supporting documentation, with possible extensions up to 12 months.
Key Application Documents
The application package must include a detailed cover letter containing:
- Trial title and protocol number;
- IRAS ID and global identifiers;
- Summary of trial design, including adaptive or novel elements;
- Safety concerns related to the investigational medicinal product (IMP);
- Confirmation that the Investigator’s Brochure (IB) or equivalent documentation has been included.
The updated UK framework aims to streamline clinical trial approvals while strengthening regulatory oversight, participant safety, and data reliability.
