Expert Advisory Pathways for Clinical Trials of Medicines in the UK

1. Purpose of expert advice

The UK clinical trials framework recognises that early and well-informed dialogue with regulators is essential for the safe and effective development of medicines. To support sponsors and investigators, the Medicines and Healthcare products Regulatory Agency (MHRA) offers expert advice services covering scientific, regulatory, and procedural aspects of clinical trials for medicines. These services aim to improve trial quality, reduce avoidable delays, and ensure participant safety. Source: Clinical trials for medicines: expert advice

2. Who can seek expert advice

Expert advice is available to a wide range of stakeholders involved in clinical development, including:

• Pharmaceutical and biotechnology companies
• Academic sponsors and investigators
• Small and medium-sized enterprises
• Contract research organisations acting on behalf of sponsors

Advice can be requested at different stages of development, from early exploratory studies to later-phase confirmatory trials. Source: Clinical trials for medicines: expert advice

3. Scope of expert advice

MHRA expert advice may cover topics such as:

• Clinical trial design, endpoints, and statistical considerations
• Use of innovative or adaptive trial methodologies
• Quality and manufacture of investigational medicinal products (IMPs)
• Non-clinical and clinical data requirements to support trial authorisation
• Safety monitoring, pharmacovigilance, and risk mitigation measures
• Interpretation of UK clinical trial legislation and guidance

The scope is flexible and tailored to the specific questions raised by the applicant. Source: Clinical trials for medicines: expert advice

4. Relationship to clinical trial authorisation

Expert advice is non-binding and does not replace the formal process for applying for a Clinical Trial Authorisation (CTA). However, it is intended to inform and strengthen CTA applications by clarifying regulatory expectations in advance. Sponsors are encouraged to reflect the outcomes of expert advice discussions when preparing their CTA submissions. Source: Clinical trials for medicines: expert advice

5. How to request expert advice

Applicants must submit a structured request outlining:

• Background information on the medicinal product and development stage
• Specific questions for which advice is sought
• Relevant supporting documentation

Requests are reviewed by MHRA, and advice may be provided through written responses, meetings, or a combination of both, depending on complexity. Source: Clinical trials for medicines: expert advice

6. Fees and timelines

Expert advice services are subject to regulatory fees, which vary according to the type and scope of advice requested. Timelines for delivery depend on the complexity of the questions and the format of advice but are defined in advance to support development planning. Source: Clinical trials for medicines: expert advice

7. Practical value for sponsors

Engaging with MHRA expert advice can:

• Reduce regulatory uncertainty
• Improve the scientific robustness of trial protocols
• Support compliance with UK clinical trial legislation
• Facilitate smoother review during CTA assessment

Early use of expert advice is particularly valuable for novel therapies, complex trial designs, or first-in-human studies. Source: Clinical trials for medicines: expert advice