Brexit has provided several challenges to the pharmaceutical industry that required robust actions and swift resolution in order to remain in compliance following the end of the transition phase.
At the ‘Brexit – Impact, Challenges, and Solutions for the Pharmaceutical Industry Conference we heard from companies expressing their need for a clear action plan to map out the activities, timings and responsibilities for these changes including those licensing activities, manufacturing, QP release and supply routes.
Focussing on the regulatory activities, the following are some of the challenges faced by companies and the steps taken by the UK Regulator, the MHRA, and the UK Department of Health and Social Care, in order to provide solutions to marketing authorisation review and access to medicines:
Following Brexit, regulatory oversight in the UK has shifted from the EMA to the MHRA, for what were European procedures, with the work of the multinational agency now falling to the MHRA. One would; therefore, question capacity and anticipate resource issues.
For companies, lack of published guidance, or guidance that is published very late, has provided issues for training, compliance and updating of internal procedures. There is a continued reliance on existing EU forms and systems, and with the separation of European procedures from Great Britain, there is a duplication of effort that stretches the capacity of the already finite regulatory resources.
This has increased the risk of potential delays to submissions and approval in Great Britain and Northern Ireland. In addition, there is the potential for a reduced supply of medicines to NI.
UK Marketing Authorisations – For Existing Products
All existing Centrally Authorised (CAP) MAs were automatically converted into UK MAs effective in Great Britain (England, Scotland and Wales only) and were issued with a new MA number on 1 January 2021 (with a format of PL GB) unless the MHRA were otherwise advised. This was a process referred to as ‘Grandfathering’.
Companies submitted initiating sequences, with baseline data, for the new GB-only grandfathered product by the end of 2021. This was a large resource burden on regulatory departments to collate these data and create a new baseline. This created a particular issue for historic products, where data may not have a readily available in CTD format, or was archived and not digitised. The MHRA took a pragmatic approach and requested companies provide as complete a dossier as possible, and that companies make all ‘reasonable endeavours’ to do so.