The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) released further guidance on the regulation of medicines, medical devices and clinical trials if there is no Brexit deal. The scenario of a so called “Hard Brexit” (U.K. to leave the EU with no deal*) is still a possibility and people need to think about this and make the necessary preparations.
As a response to the recent EU exit no-deal legislative proposals, the MHRA has issued an updated guidance defining some proposed arrangements if the U.K. will leave the EU on 29 March 2019 with no deal.
For Clinical Trials of investigational medicinal products (IMPs), some of the key arrangements include:
- European regulatory network: The MHRA would take on the responsibilities for the UK that are currently undertaken through the EU system for clinical trials and will continue to recognize existing approvals – both for regulatory and ethics approvals (no need to re-apply).
- Sponsor or legal representative: The UK would require sponsors or legal representatives to be in the UK or country on an approved country list which would initially include EU/EEA countries (for clinical trials in the UK).
- Regulatory framework: The new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU at the time that the UK exits the EU. So, it will not be incorporated into UK law on exit day. However, the UK Government issued a clear commitment to align where possible with the CTR without delay when it does come into force in the EU.
- Testing and certification of IMPs: For IMPs coming into the UK, the UK will recognize QP certification done in an approved country (which would initially include all EU/EEA countries). No additional QP certification (re-certification) in the UK will be required for IMPs coming from these (approved) countries.
- Import licensing: Importers of IMPs into the UK will require a Manufacturers Licence (MIA). For IMPs coming from countries on the approved country list the MIA(IMP) holder will be required to put in place an assurance system to check these IMPs have been QP certified in the EU or EEA. This assurance system must be overseen by a QP. IMPs coming from other countries would require QP certification in the UK by the MIA(IMP) holder. Sponsors will have 12 months after EU Exit to comply with this.
- Safety reporting: Sponsors will be required to submit all UK relevant suspected unexpected serious adverse reactions (SUSARs) reports to the MHRA. These would need to be submitted via UK based IT systems (as the option to report via EMA systems will no longer exist).
- Clinical trials applications: UK clinical trial applications would continue to be authorized by the MHRA / ethics committees – the UK ability to participate in multinational trials will not change.
- Publishing trial results: By the time the EU’s new portal goes live (as part of the new CTR), the UK will have its own specific hub that would give both the UK patients and researchers a single reference point for all UK trials.
*UK would leave not only the EU but also the EU’s Single Market (of which non-EU countries are also members) and the EU Customs Union (of which non-EU countries are also members).