New guidance published on the 150-days national and EC decision reliance procedures

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided detailed information on submission dates and processes for the 150-days national and European Commission decision reliance procedure (ECDRP).

For high-quality marketing authorisation applications (MAAs), the MHRA will review submissions using the 150-day Assessment route. For MAAs containing new active substances, submission dates should align with meeting dates of the Commission on Human Medicines (CHM). The MHRA has provided details of this alignment schedule:

CHM meeting Submission deadline
6 and 7 May 2021 8 February 2021
27 and 28 May 2021 1 March 2021
1 and 2 July 2021 5 April 2021
5 and 6 August 2021 10 May 2021
2 and 3 September 2021 7 June 2021
30 September and 1 October 2021 5 July 2021
28 and 29 October 2021 2 August 2021
25 and 26 November 2021 30 August 2021
16 and 17 December 2021 20 September 2021
27 and 28 January 2022 1 November 2021

The ECDRP is a route in which applicants may seek a Great Britain (England, Scotland and Wales) marketing authorisation based on a decision taken by the EC for the same product via the centralised procedure. Timelines for applications using this route revolve around the Committee for Medicinal Products for Human Use (CHMP) conferring a positive opinion on an application. The applicant should submit the ECDRP MAA to the MHRA via a single eCTD sequence through MHRA submissions as soon as possible upon receipt of a positive CHMP opinion. This should include the entire dossier as reviewed by the CHMP.

When a submission is made within 5 days of a positive CHMP opinion, the date of the opinion will be designated as Day 0 for the ECDRP and the MHRA will strive to approve the application as soon as possible. However, if the submission is made more than 5 days after the positive CHMP opinion, Day 0 will be the date of MAA validation and determination may not align with the date of the EC decision.

To read the notice in full, click here.