Recently the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated their "150-day assessment for national applications for medicines" guidance with respect to updates to the Pre-submission meeting section.
As part of its efforts to speed up access to medicines in the UK, the MHRA provides a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs).
As part of this process, the MHRA will evaluate the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation within 150 days of receiving the application.
The 150-day assessment is available for all high-quality new MAAs submitted to MHRA and also applies for a marketing authorisation (MA) for new active substances and biosimilar products or existing active substances.
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required
Phase I is completed within 80 days after the clock starts. A 60-day clockoff period will be provided for the applicant to address any issues raised during the initial assessment.
Phase II: Assessment will begin on receipt of the applicant’s responses. Based on the assessment, the MHRA will provide an opinion on approvability of the product by day 150, and if positive, will grant the MA.
If the MHRA refuses to grant the MA-based on advice from Commission on Human Medicines (CHM), there is an opportunity for the applicant to request a review of the decision.
Click this LINK to know more about the Pre-submission meeting and detailed information on 150-day assessment for national applications for medicines.
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