01 · Regulatory facts
The briefing comes with the request.
MHRA’s updated process requires final questions and full briefing documents when requesting scientific advice from September 2026. Each question should include the organisation’s proposed approach, rationale and scientific justification. Significant later changes to the questions or scope can lead to rescheduling and a new request.
This is operational guidance, updated on 14 August 2026. No exact September start day or consultation deadline is specified. Scientific advice is not binding and does not guarantee subsequent approval. See the official guidance
02 · Tenvia interpretation
Keep the reasoning with the question.
For Sponsors and CROs, preparing for advice is also a protocol development task. The clinical question, the proposed design and the evidence behind it need to be understandable together.
Identify the protocol section, the question for discussion and the team’s proposed approach.
Keep relevant sources, assumptions, conflicting evidence and missing justification visible.
Confirm who has reviewed the position and what changed since that review.
These are Tenvia’s preparation principles, not additional MHRA requirements. They support a more focused discussion without pretending that a complete document proves the design is appropriate.
03 · Planned capability · Not currently available
Briefing preparation within Protocol Intelligence.
We have added a reviewable briefing draft to the Protocol Intelligence build plan. The intended workflow connects each question to its protocol context, proposed approach, evidence, assumptions and reviewer, then brings those elements into a controlled draft.
Delivery follows the required evidence and review foundations. Qualified people retain the decision. Export and sharing require separate authorisation; automatic MHRA submission is not part of the planned capability.
This is a product direction, not a demonstrated feature, regulatory endorsement or claim of submission readiness.
Review the current product scopeChecked 8 September 2026
UK operational guidance. Update history: 14 August 2026. Requirement applies from September 2026.