Medicines: get scientific advice from the MHRA

From September 2026, organisations should provide the full briefing document(s) at the point of submission of a Scientific Advice request.

Scientific Advice is an advisory function from the MHRA to aid product development.

You can ask the MHRA for scientific advice at any stage of your medicine’s development or regulatory lifecycle. You can ask for specific advice on a single development programme or product lifecycle, or broader advice not limited to a single development program or product lifecycle.

Advice is requested through the online form (see the Ask for scientific advice). You can request written advice only, or a meeting followed by a written summary of advice (see the Types of meeting section for more information on written advice provided after meetings). If written advice is requested, the MHRA will decide if it is appropriate to do so or whether a meeting is required.

You can ask for a meeting with the MHRA only through the link Request MHRA Scientific Advice, or a joint meeting with the MHRA and the National Institute for Health and Care Excellence (NICE) (see the Integrated Scientific Advice section).

The  advice provided by the MHRA will be based on the questions and documents you provide (see Supporting Documents Guidance). The advice cannot account for future changes in scientific knowledge or regulatory requirements.

Scientific advice from the MHRA is not legally binding for future applications of the discussed product. You should not consider the advice as an indication of a future agreed position.

Process and timelines

The time it takes to get written advice or advice via a meeting depends on the subject matter and expertise needed. We strongly encourage early planning and sending of advice requests with a final list of questions and briefing document(s) at the point of submission.

For requests, you must send your final questions list and briefing document (s) should be provided at the point of submission to the MHRA.

A contact person from the MHRA will offer a meeting date (or for written advice, provide a timeline of when the advice letter will be sent) within 10 working days of the acknowledgment of the submission, provided the request is in scope.

After most meetings the MHRA will provide a written summary of advice (see the Types of meeting section). If offered, the MHRA will send this final advice letter within 30 working days of the meeting taking place.

MHRA expertise on offer

The MHRA has extensive experience and expertise to answer questions on your medicine’s lifecycle. To get the best advice and access the most relevant experts, the questions you send in advance should be clear and specific.

For advice on writing questions, go to the Supporting document guidance section.

Types of meeting

Scientific advice meeting

The MHRA primary advice service is targeted scientific advice for individual products.