Mandatory Submission of Briefing Documents for Scientific Advice Requests

Key changes

Mandatory submission of the full briefing document(s) at the point of request for scientific advice; implementation effective from September 2026.

PV impact

This change requires PV teams to finalize safety-related briefing materials—including RMPs, PASS protocols, and risk management strategies—much earlier in the development lifecycle. Regulatory and PV coordination must be intensified to ensure all safety documentation is ready for the initial submission.

Exact policy details

Submission of Briefing Document

Final briefing document(s) must be submitted at the point of request.

Applies to: Mandatory from September 2026 for all organizations requesting scientific advice.

Updated to inform organisations that they are required to submit their final briefing document(s) and questions at the point of requesting Scientific Advice, with this becoming mandatory from September 2026. · p. 1 · High · Source

Response Timeline

MHRA will provide meeting date or timeline for written advice within 10 working days of submission acknowledgment.

Applies to: All requests for scientific advice.

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. · p. 1 · High · Source

Written Advice after Meeting

Final advice letter will be sent within 30 working days after the meeting.

Applies to: Applicable for scientific advice meetings.

If offered, the MHRA will send this final advice letter within 30 working days of the meeting taking place. · p. 1 · High · Source

Fee Payment Deadline

Fees must be paid at least 15 working days before the meeting.

Applies to: All requests for scientific advice that require a fee.

You need to pay at least 15 working days before your meeting date, or your meeting may be delayed. · p. 1 · High · Source

SME Fee Exemption

UK-based SMEs with approved status do not have to pay for scientific advice.

Applies to: UK-based SMEs with approved SME status.

UK-based small and medium-sized enterprises (SMEs) with approved SME status do not have to pay for scientific advice. · p. 1 · High · Source

Workflow rule impacts

Extracted documents

• Medicines: get scientific advice from the MHRAhtmlhtml · high · 1 page
• full briefing document(s)docxdocx · high · 1 page
• Medicines: Get integrated scientific advice from the MHRA and NICEhtmlhtml · high · 1 page