01 · Regulatory facts · UK
A broader programme, with defined limits.
MHRA’s 30 September update expands potential eligibility beyond healthy volunteers to certain Phase 1 studies in non-oncology patients where safety is the primary objective. It explicitly includes bioequivalence, drug–drug interaction, mass-balance and QT studies, and allows up to three active investigational medicinal products, subject to the full criteria.
The staged timetable lists an 18-calendar-day first assessment target from 28 September 2026 and a 14-day target from 28 December 2026. The assessment clock follows validation; booking capacity is limited. First-in-human trials and several other categories remain excluded. This is operational guidance, not a new general protocol standard. No consultation deadline is stated.
Source caveat: some introductory wording still refers to healthy volunteers and March 2027, while the revised table and timetable are broader and specify December 2026. Confirm uncertain cases with MHRA. Publication date, timetable stage and applicability to a particular study are separate questions.
02 · Tenvia interpretation
Make the reasoning reviewable before the handoff.
For Sponsors and CROs, the practical opportunity is to make the protocol easier to understand and challenge. A timetable does not resolve a missing rationale, an inconsistent study description or an unanswered safety question.
Check that the synopsis and detailed protocol agree on the population, primary objective, study type and investigational products.
Identify the source and version behind a design assumption. Make gaps and conflicting information visible to the people qualified to resolve them.
Keep the reviewer’s rationale with the decision, including matters that still need regulatory clarification. A recorded assumption is not confirmed eligibility.
These are discussion prompts for protocol teams, not a programme eligibility checklist. They reflect Tenvia’s focus on connected protocol reasoning; they do not announce a new product capability.
Explore the cross-functional review discussion guide →03 · Important boundaries
The accountable team makes the decision.
Tenvia does not determine eligibility for this programme, book assessment slots or guarantee approval or faster clearance. Clinical safety, regulatory interpretation and submission decisions remain with qualified professionals. This article does not establish submission readiness, compliance, regulatory endorsement or permission to start a study.
Programme criteria can change. Use the current official guidance and obtain clarification where necessary; do not use this commentary as regulatory advice.
04 · Official sources
Read the source and its update history.
MHRA publication and 30 September update record ↗
Full programme guidance, criteria and timetable ↗
Based on the MHRA material reviewed on 30 September 2026. This is independent Tenvia commentary, not an MHRA publication.