Obtaining Scientific Advice from MHRA for Medicines Development

1. Overview

You can request scientific advice from the MHRA at any stage of your medicine’s development or regulation. This includes written advice only or meetings, with written summaries provided after some meetings. Advice can be specific to a single development programme or broader. Joint meetings with the MHRA and NICE are available. The advice is based on provided questions and documents, not accounting for future changes, and is not legally binding. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

2. Process and Timelines

The timeline varies by subject and expertise. Early planning is encouraged. For meetings, final questions and briefing documents must be sent 15 working days in advance, or the meeting will be delayed. Written summaries, if provided, are sent within 30 working days post-meeting. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

3. MHRA Expertise

MHRA offers expertise across the medicine lifecycle. Clear, specific questions ensure access to relevant experts. Guidance on formulating questions is in the supporting documents section. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

4. Types of Meetings

4.1 Scientific Advice Meeting

Targeted for individual products, encouraged at key stages like first-in-human studies, pivotal trials, CMC requirements, bioequivalence studies, and reclassification. Meetings last up to 90 minutes, with written advice provided afterward. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

4.2 Broader Scope Advice Meeting

For general approaches, complex plans, endpoints, etc., not product-specific. Meetings up to 90 minutes, no written advice provided. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

5. Joint Scientific Advice with MHRA and NICE

Detailed guidance on integrated service available. Access via specific portal. Collaboration aims for aligned decisions and faster patient access. Webinar link provided. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

6. Requesting Scientific Advice

Use the online form for requests. Prepare necessary documents beforehand. MHRA processes upon receiving complete questions list. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

7. Supporting Documents

Upload briefing documents and questions. Documents due 15 working days before meetings. Briefing includes presentations, labelling examples; appendices for background. Questions focus on specific issues like quality, non-clinical, clinical aspects. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

8. Before the Meeting

Send briefing documents 15 working days prior. MHRA may provide provisional advice or questions. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

9. At the Meeting

Start with short presentation. Meetings may be recorded for internal use. Provide notes within 15 working days post-meeting. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

10. After the Meeting

Send notes within 15 days. MHRA sends advice letter within 6 weeks for applicable meetings. Clarifications via email or meeting, but no scope expansion without additional fees. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

11. Limitations of Advice

Advice is without prejudice, does not override laws or affect third-party IP rights. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

12. Fees

Fees detailed in linked publication. Pay via link, 15 days before meeting. UK SMEs with status exempt. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

13. Contact

Email: scientific_advice@mhra.gov.uk https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

14. Publication and Updates

Published 29 December 2014, last updated 4 March 2026. Multiple updates listed. https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra