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UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines

Earlier today (05 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "150-day assessment for national applications for medicines" that pro guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.


What is the 150-Day Assessment Period?

When a pharmaceutical company seeks to market a new medicine in the UK, it must submit a marketing authorization application to the MHRA.

For national applications (i.e., those not covered by the centralized European Medicines Agency (EMA) procedure), the MHRA follows a 150-day assessment period to review the application and make a decision on whether to grant the marketing authorization.


The MHRA provides a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming to speed up access to medicines for UK patients.


New active substances and biosimilar products as well as existing active substances will undergo assessment after the application has been validated. A valid application/dossier should contain common technical modules (CTD modules 2-5), as well as an appropriate Risk Management Plan (RMP), UK PIP CC, and/or compliance with UK Orphan Medicines requirements, when applicable.


The major update of this guidance is the inclusion of the Fees Calculator which will help to identify what the fee for your submission will be.


Phase I of the assessment process will last 80 days after the clock begins, followed by phase II of the assessment process lasting 150 days. If necessary, there will be a clock-off between phases I and II.


As part of the assessment process, the MHRA will seek advice from CHMs and/or therapy area experts (specialty expert groups), as required. Based on the assessment, it will provide an opinion on approvability by day 150, and if positive, it will grant the MA.



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