National assessment procedure for medicines

AI Summary

This guidance outlines the Medicines and Healthcare products Regulatory Agency’s (MHRA) updated national assessment procedure for Marketing Authorisation (MA) applications. Effective immediately, with specific process updates for established medicines as of March 1, 2024, the framework is governed by the Human Medicines Regulations 2012 and the Windsor Framework. The Windsor Framework requires products to be assigned to specific categories to ensure licensing across the entire United Kingdom. The procedure differentiates between innovative medicines, such as new active substances and biologicals, and established medicines. The MHRA aims for a final decision within 150 to 210 days. Primary issues that may lead to delays or refusal include 'major objections' regarding a medicine's safety, quality, or efficacy, as well as technical incompleteness of the application. Required actions for companies include submitting a pre-submission notification three months in advance, ensuring UK Paediatric Investigation Plan compliance 60 days before applying, and using the MHRA Submission Portal for all electronic Common Technical Document (eCTD) filings. If the MHRA identifies deficiencies, applicants must respond to Requests for Information (RFI) within six months. Failure to meet these deadlines or resolve major objections raised by the Commission on Human Medicines (CHM) may result in the rejection of the application. The guidance also promotes the Access Consortium for applicants seeking simultaneous work-sharing reviews across multiple international markets.