Established medicines: marketing authorisation application changes

AI Summary

Effective March 1, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) introduced significant procedural changes for Marketing Authorisation Applications (MAA) regarding established chemical medicines. Operating under the Human Medicines Regulations 2012, these updates aim to improve efficiency by addressing frequent submission flaws, including bioequivalence inaccuracies, inappropriate biowaivers, and inadequate testing for impurities such as nitrosamines. Under the new framework, the MHRA will no longer process incomplete applications, which will be refused during the initial technical check. A pivotal change is the limitation to a single Request for Further Information (RFI). Applicants must provide a comprehensive response within 60 calendar days, as no extensions will be granted except under exceptional circumstances. Failure to resolve all issues within this single RFI cycle will lead to a recommendation for refusal. Required actions for applicants include submitting comparative product information and updated stability data in Microsoft Word format rather than PDF. Additionally, successful applicants must now provide a prepopulated lay summary for the UK Public Assessment Report (UKPAR). These measures shift the burden of quality onto the applicant, requiring 'right-first-time' submissions to ensure timely regulatory approval.