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MHRA releases new guidance on national medicine marketing authorisation process

Copyright © 2025 LexisNexis

Published on: 04 April 2025

Published by LNB News

LNB News 04/04/2025

Document Information

Issue Date: 04 April 2025

Published Date: 04 April 2025

Jurisdiction(s): England, Northern Ireland, Scotland and Wales

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 3 April 2025 detailing its national assessment procedure for marketing authorisation applications. The guidance introduces separate pathways for innovative and established medicines, with innovative medicines eligible for decisions within 150 days if issues are resolved in one round, while both categories have a maximum timeline of 210 days. The document implements Windsor Framework changes affecting product categorisation and outlines specific submission requirements, assessment phases and consultation procedures with the Commission on Human Medicines.

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