In this 'Brexit News' close-up our Regulatory Intelligence team will provide a commentary and updates on recent British Government briefing around Brexit implication on medicines, devices and clinical trials. Also, will be analysed the early implication of EMA Phase 3 implementation business continuity plan in preparation of Brexit.
Government updates: ‘no deal’ Brexit regulatory advice on medicines, devices and clinical trials
Whilst the UK Government remains ever hopeful of a negotiated deal including a transitional period following the UK’s exit from the EU on 29-Mar-2019, they have released two updated guidelines providing greater clarity and advice on what will happen if there is no Brexit deal on:
- submitting regulatory information on medical products; and
- how medicines, medical devices and clinical trials will be regulated
These guidelines detail the how the Medicines and Healthcare products Regulatory Agency (MHRA) would continue to work with MAHs on the registration and surveillance of medicines, devices and clinical trials, and includes information on pharmacovigilance aspects such as the submission to the MHRA of UK and foreign Individual Case Safety Reports (ICSRs), submission of Periodic Safety Update Reports (PSURs) and reinstatement of sending Anonymised Single Patient Reports (ASPRs) to MAHs, all of which is now largely centralised through EMA systems. Of note, this guidance mentions that there would be a need to register a Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File directly with the MHRA so continuing to the spirit of the European framework for pharmacovigilance and Good Pharmacovigilance Practices (GVP) requirements even if the UK remains outside its remit. Finally, the guidance states that new systems and processes will be in place to facilitate such activities as mentioned above and more information would be made available prior to Mar-2019.
We continue to watch developments in Brussels for any indication of whether these UK contingency plans will be necessary in a post-Brexit Europe
EMA initiates Phase 3 implementation of its Business Continuity Plan
The European Medicines Agency (EMA) has initiated the Phase 3 implementation plan of its Business Continuity Plan (BCP). This is in response to preparations for Brexit and a larger than initially anticipated loss of staff when its headquarters relocates to Amsterdam next year. What this means in practice is that the EMA will be further scaling back of its activities to focus primarily on the more important ‘Category 1’ activities from 01-Nov-2018 until 30-Jun-2019.
One area impacted by this scaling back is work of developing all EMA and international guidelines, except where these are deemed urgent due to public health need or in the context of Brexit / legislative preparations. One notable exception is the development of a Good Pharmacovigilance Practice guidance document on Pregnancy and Breast-feeding where work continues, and the release of this guidance is anticipated in Q4-2018.
- UK Government’s advice for submitting regulatory information on medical products if there’s no Brexit deal
UK Government’s advice on how medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
- EMA’s BCP Phase 3 Implementation Plan