Submission and Assessment Timetables for Innovative Medicines Applications in the UK

Overview

This guidance provides timelines for submission and assessment of responses to the first Request for Information (RFI) under the UK marketing authorisation process for innovative medicines. The timetables are intended to support applicants in planning their responses and coordinating with the Commission on Human Medicines (CHM) where required.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK

MHRA Timetable Structure

The Medicines and Healthcare Products Regulatory Agency (MHRA) sets monthly submission deadlines for responses to the first RFI to help ensure consistent assessment activities and allow for CHM consultation as needed. These dates fix when the procedure restarts after a response is submitted.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK

Example Timeline Summary

The official guidance lists submission deadlines, procedure restart dates, and estimated CHM meeting and second RFI timepoints for applicants to follow. For example:

• Submission deadline: 02/01/2026 → Procedure restart: 05/01/2026 → CHM meeting: 26/02/2026 → Second RFI or CHM letter: 05/03/2026
• Submission deadline: 30/01/2026 → Procedure restart: 02/02/2026 → CHM meeting: 26/03/2026 → Second RFI: 02/04/2026
  (… and further monthly entries are provided in the timetable.)
  Source: Submission and assessment timetables for innovative medicines applications - GOV.UK

Purpose of the Timetables

The timetables help applicants understand when to submit responses to RFIs, when the regulatory clock restarts, and when key CHM interactions or follow-up information requests are expected. This enables transparency for timelines to resolve questions about quality, safety, or efficacy during the review.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK

Planning Your Response

Applicants should prepare RFI responses as eCTD sequences (electronic Common Technical Document) and submit before the relevant deadline to avoid delays. The MHRA restarts the assessment clock 3 calendar days after submission.
Source: related MHRA guidance context

Next Steps After Timetables

Once responses are assessed, the MHRA may issue a second request for information or a CHM letter if significant issues remain. Final marketing authorisation decisions may follow later in the national assessment procedure.
Source: related MHRA guidance context