This overview is based on MHRA webinar from 5th of May 2025.
The new UK national procedure for marketing authorisations became effective on 3 April 2025. There are differences in the guidance for new medicines and established medicines, however as a general rule the assessments are performed within 210 regulatory clock-on days. The clock-off time will be when the application is back with the applicant for response. Project Orbis applications, which cover innovative cancer drugs, will be considered, however the international recognition procedures are not in the scope of this procedure.
The new national procedure for marketing authorisations allows earlier than 210 approvals when there are minor issues. It is applicable for new active substances (chemical or biological), advanced therapy medicinal products (ATMPs), vaccines, biosimilars, new combinations of existing active substances, orphan medicinal products, applications for conditional marketing authorisation or exceptional circumstances, and line extensions for any of the above.
Innovative Medicines Procedure
The companies have to notify MHRA of the intended submission date at least 3 months in advance and provide pre-submission notification form. For new substances and biological or biosimilar products it is recommended to request pre-submission meeting. In case a paediatric compliance check is required it is recommended to submit such request at least 60 days before the application is submitted. There is a fixed submission and assessment timetable with dates until end of 2026. This information is available on MHRA website.
There is a 3 weeks validation period. Initial assessment takes 90 days which will include orphan designation if applicable. It is important to remember that the clock stops when there is a request for information (RFI) and the applicant can request clarification meeting if needed. The applicant has to respond within 6 months which then restarts the regulatory review clock. It is possible to request extension but ideally responses will be provided within 6 months. At day 150 it could be that all issues are resolved or there may be some follow up questions. If there is a second round of questions the applicant should response as soon as possible but no later than 3 months. There is a possibility for a 3rd set of questions although it was commented by the presenter that this is not common.
Established Medicines Procedure
The process for established medicines does not have fixed timetable. The validation will take 14 days. In the first phase there will be a technical completeness check, then followed by scientific assessment. If there is a request for information this should be responded within 6 months and in case of second round of questions the applicant has to respond within 3 months. The assessment will be completed within 210 days. The clock will stop when there is a request for information.
Common issues observed with the applications
Many submissions were completed in a rush with copy/paste information from Module 3. The data is not summarized well and there is no analysis.
The Quality Overall Summary (QOS) should contain relevant information on manufacturing and control methods, batch consistency and covering safety concerns. It is recommended to use tables and figures and link data across sections to make it easier for review.
Any issues should be addressed adequately. The companies should explain the issue and how they have resolved it and prevent it in the future. Addressing them is preferred over ignoring them.
Some recommendations from MHRA
Including table or list of contents for each section helps assessors to review the application quicker.
All submitted documents should be appropriately named.
Providing word documents for Module 2 could support quicker review.
Using old reference product Summary of Product Characteristics (SPCs) and Patient Information Leaflet (PILs) could raise additional questions.
It is recommended to prepare tabular comparison of the proposed and reference SPC or PIL with justifications for the changes.
It is important to explain why studies are included in the application and what is their relevance.
Published on 28 May 2025
