The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its comprehensive guidance on the national assessment procedure for marketing authorisation applications. This policy paper, originally effective from 3 April 2025, establishes a clear distinction between 'innovative medicines'—such as new active substances and biologicals—and 'established medicines'. The October 2025 revision further clarifies the procedural expectations for applicants to ensure high-quality submissions and predictable regulatory timelines.
A core component of the updated procedure is the implementation of fixed assessment timetables. For innovative products, the MHRA aims to reach a decision within 150 clock-on days, provided the applicant resolves all queries within a single round of questions. If further review is necessary, the timeline extends to a final decision by Day 210. Established medicines are generally assessed within a 210-day window, though simpler applications may be granted sooner.
The agency has significantly tightened its initial validation phase. Technical completeness checks are now performed immediately; if the required data are found to be missing or non-compliant with the Human Medicines Regulations, the MHRA will refuse the application at the outset. For established medicines, the regulator typically issues only one request for information. Applicants must respond to these queries within six months to avoid automatic refusal, ensuring that the regulatory clock restarts only when the submission is fully addressed.
Current next steps for developers include submitting a mandatory pre-submission notification form at least three months before an intended application date for innovative products. The MHRA also strongly recommends pre-submission meetings for biological substances to ensure technical robustness.
The impact of these changes is a more rigid but highly predictable path to market. By adhering to fixed milestones and stricter validation criteria, the regulator minimizes the risk of backlogs. Those responsible for securing market entry can now forecast approval dates with greater precision, provided their initial dossiers are technically complete from the point of submission.
Source: National assessment procedure for medicines
Date: 23 October 2025
