UK MHRA Guidance: Get Scientific Advice from MHRA- Comprehensive Guide

Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates. The Medicines and Healthcare products Regulatory Agency (MHRA) offers scientific advice to help organizations at every stage of a medicine’s development or regulation. This guidance is essential for pharmaceutical companies, biotech firms, and researchers aiming to ensure their products meet regulatory standards and reach patients efficiently.

MHRA scientific advice is a service that provides tailored guidance on the development, regulation, and lifecycle management of medicines. Organizations can request advice in writing or through meetings, covering specific products or broader development strategies.

The advice is based on the information and questions provided by the applicant and is not legally binding for future applications.

The MHRA offers tailored scientific advice across all stages of medicine development and regulation, ranging from focused written input to in-depth meetings. These can address specific products or broader development themes. You can also opt for a combined meeting with MHRA and the National Institute for Health and Care Excellence (NICE) to align clinical trial design with health technology assessment requirements.

Key features include:

• Written advice or meetings (MHRA alone or joint with NICE)

• Applicable at any stage—from early development through post-authorization

• Advice is non-binding and reflects the information supplied at the time; future scientific or regulatory changes are not covered 

After submitting a request, the MHRA acknowledges it within 10 working days. For meetings, finalized briefing and questions are required at least 3 weeks in advance, and a written advice letter is provided within 6 weeks after the meeting.

1. Scientific Advice Meeting

• Targeted for individual products.

• Recommended at key development milestones, such as first-in-human studies, pivotal clinical trial design, CMC/biological process requirements, bioequivalence studies, and reclassification/repurposing programs.

• Meetings are structured, last up to 90 minutes, and are followed by written advice.

  
  

2. Broader Scope Advice Meeting

• Covers general or complex development issues, not limited to a single product.

• Topics include overall development plans, complex drug/device combinations, study endpoint selection, risk management, and legal reclassification.

• Less structured, up to 90 minutes, and typically no written advice is provided.

  
  

3. Joint Scientific Advice with MHRA and NICE

• Joint meetings with the National Institute for Health and Care Excellence (NICE).

• Focus on aligning clinical study designs with both regulatory and health technology assessment requirements.

• Meetings last up to 3 hours, with separate advice documents from MHRA and NICE.

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How to Ask for Scientific Advice

Requesting MHRA scientific advice involves a structured process to ensure clarity and efficiency1:

• Complete the “Ask for scientific advice” form, which guides applicants through the necessary steps.

• A complete list of questions is required before the MHRA can process the request.

• After submission, the MHRA acknowledges receipt within 10 working days.

• For meetings, a mutually agreed date is set, and all documentation must be submitted at least 3 weeks in advance.

Supporting Document Guidance

Applicants must provide comprehensive supporting documents to facilitate effective advice:

• Briefing Document: Should include all relevant presentations, labelling/artwork examples, and essential appendices (e.g., study protocols, previous advice, guidelines).

• Questions List: Focus on future development, variations, or risk management, covering quality, non-clinical, clinical, pharmacovigilance, and regulatory aspects.

Before the Meeting

• Submit the final questions list and briefing document at least 3 weeks before the meeting.

• MHRA staff review documents and may provide provisional advice or request clarification.

At the Meeting

• Meetings often begin with a 10–15 minute presentation by the applicant, summarizing key issues.

• The meeting may be recorded (for MHRA use only) to aid in preparing written advice.

• Applicants should take notes and provide them to the MHRA within 15 working days.

After the Meeting

• Submit meeting notes within 15 working days.

• For most meetings (except broader scope advice), the MHRA provides a scientific advice letter within 6 weeks.

• Clarifications can be requested, but expanding the scope or adding new questions will incur additional fees.

Limitations of MHRA Advice

• Advice is given “without prejudice” and does not override legal requirements for marketing authorizations or other applications.

• Does not affect third-party intellectual property rights

By understanding the types of meetings, documentation requirements, and process timelines, applicants can maximize the benefit of this service and streamline their path to regulatory approval. For further details and the most current guidance, refer to the official MHRA LINK.