Snapshot

The 150-day assessment for national applications for medicines pathway has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom.

This pathway can be used where The MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK. Applicants can apply for a marketing authorisation (MA) for new active substances and biosimilar products or existing active substances. There are different application processes but all applications should be submitted through the MHRA Submission Portal. For New active substances and biosimilar products applications, the MHRA recommends applicants to email AcceleratedandRollingReview@mhra.gov.uk before they intend to submit an application. Applicants should tell the MHRA the intended date of submission of the dossier and whether the MAA is to be submitted to UK, Great Britain (England, Scotland and Wales) only, or Northern Ireland only. If the application includes Northern Ireland, then it must comply with EU requirements. Before applicants submit their application, they should read the MHRA's guidance on Procedures for UK Paediatric Investigation Plans (PIPs) [https://www.gov.uk/guidance/procedures-for-uk-paediatric-investigation-plan-pips] A UK PIP compliance check (CC) should be completed 60 days before the applicants' intended submission. For medicinal products presented or used with a device component, applicants should read the MHRA's guidance on regulating medical devices: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk MHRA will arrange a pre-submission meeting with applicants..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The assessment process includes consultation with the CHM on fixed dates each month. The submission slots will be linked to the dates of CHM meetings. The MHRA may additionally wish to seek advice or input from therapy area experts (specialty expert groups) during the assessment process. 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. Assessment phase I will be completed 80 days after the clock starts. Issues arising or requiring clarification from the initial assessment will be raised with the applicant as a letter requesting further information (RFI) and should be addressed within the clock off period of 60 days. Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions. Applicants may contact the assessment team for discussing issues raised in the RFI letter. Assessment in phase-I will also address eligibility for grant of orphan status. Phase II assessment will commence on receipt of the applicant’s responses. Applicants are recommended to contact the MHRA Assessment Team in advance of the intended date of submission of response to align with CHM meetings. Based on the assessment, the MHRA will provide a decision on approvability of the product by day 150. For new active substances and biosimilar products the orphan status will be determined at the time of MA grant. If orphan status is not agreed and the company wishes to appeal this decision, the grant of a marketing authorisation will only be possible when the appeal process is completed. 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 proposes to refuse to grant the MA based on advice from CHM, there is an opportunity for the applicant to request a review of the 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. Conclusion of the assessment will lead to the publication of a UK Public Assessment Report for the product.