Submission and assessment timetables for innovative medicines applications

AI Summary

This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the national assessment procedure for Marketing Authorisation (MA) applications for innovative medicines. The regulatory framework applies to pharmaceutical companies seeking to market new active substances, biological products, vaccines, biosimilars, and orphan medicinal products. The guidance establishes a structured assessment timetable to facilitate consultation with the Commission on Human Medicines (CHM). Key required actions include the submission of a pre-submission notification form at least three months prior to the intended application date. For companies developing new active substances or biological products, the MHRA strongly recommends holding pre-submission meetings. All application dossiers and responses to the first Request for Information (RFI) must be submitted electronically via the MHRA submissions portal. The document provides detailed deadlines for procedures starting between November 2025 and September 2028. As this is a guidance document rather than an enforcement action, there are no specific company violations or inspection dates listed; however, it clarifies that applications failing validation by the procedure start date will be deferred to the next cycle. This framework ensures a predictable and rigorous review process for innovative treatments within the UK market.