Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: 150-day National Procedure

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on new assessment procedures that will be available from 1 January 2021, after the end of the transition period. In the first of a series of publications, Nasos Kipentzoglou takes an in-depth look at the procedure and the possible implications for manufacturers.

150-day National Procedure

Summary

Guidance on 150-day assessment for national applications for medicines describes a new national accelerated assessment route for Marketing Authorisations (MAs) in the UK. Under this process, the MHRA will evaluate a UK MA application and reach an opinion within 150-days after submission of the application. The application route is available for new active substances, biosimilars and existing active substances.

Timetable

The assessment includes two phases totalling 150 days with a 60-day cool-down period if needed.

Phase I

Assessment phase I will be completed within 80 days after the successful submission of the application. During that assessment stage, any issues arising will be communicated to applicants in a letter requesting further information (RFI letter). These issues should be addressed within the cool-down period (60 days). Applicants will be able to request an extension of that period, for additional 60 days, but the extension will be granted only to exceptional circumstances. Additionally, in that stage, the eligibility for granting an orphan status will be assessed.

Phase II

Assessment phase II will commence once the applicant has resolved the raised issues and the responses have been received. The MHRA will initiate a process of a ‘fixed submission date’ to facilitate consultation with the Commission on Human Medicines (CHM).

Application process

For new active substances, biosimilars and existing active substances, the guidance provides a description of the content and format of the documents that will lead to successful applications/dossier submission. These guidelines include common technical modules 2-5 (CTD) and a UK specific CTD module 1, the summary of product characteristics, patient information leaflet and active substance master file if applicable. Applications must also include a cover letter. The cover letter should detail any further intentions to seek orphan status or an MA under exceptional circumstances, as applicable. Applications should be submitted via the MHRA Submission Portal.

For new active substances and biosimilar products, the guidance advises:

• Applicants to communicate with MHRA prior to submission, informing the MHRA of the intended date of dossier submission. Additionally, should state if the application is intended to UK or GB only or NI only.
• Applicants should inform the MHRA of the pre-submission meeting and issues that they would like to raise during the meeting. The pre-submission meeting offers the opportunity to discuss UK compliance checks for the Paediatric Investigation Plan (PIP) and crucially may offer the opportunity to enhance joint discussions with the National Institute for Health and Care Excellence (NICE)

For existing active substances, applicants should refer to the MHRA guidance on Reference Medicinal Products for applications made only to GB. They are also advised to consult any MHRA product-specific bioequivalence guidance for applications made only to GB.

Appeals

The applicant can request a review of a negative decision. The procedure for such review is set out in Schedule 5, and paragraph 11 of Schedule 11, to the Human Medicines Regulations. The MHRA decision letter will detail the appeal process and timelines.

The orphan status will be determined at the time of marketing authorisation. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a MA will only be possible when the appeal process is completed.

Implications for manufacturers

In a post Brexit era, the MHRA is aiming to ensure that the UK is, and will be, a top-priority market for launching new medicinal products. The structure of the 150-day National Procedure will offer the chance for manufacturers to engage earlier with the MHRA and resolve any potential arising issues. The MHRA will operate on predefined dates with CHM and applicants, ensuring an opinion is reached within the timelines. Crucially, for new active substances and biosimilars, the process enables an opportunity to run parallel advice and enhance early dialogue with NICE. This is a critical step to maximise the opportunity to successfully navigate potential technology assessments with NICE and accelerate access for new and innovative medicines.

Article published 9 March 2021.