While the European Medicines Agency (EMA) has already published a number of guidance documents for companies, this is the first formal UK guidance for the life sciences sector. It has been produced by the UK Department of Health and Social Care (DHSC) together with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD).
While the new guidance confirms the anticipated position rather than containing significant new information, it provides helpful reassurance that the UK authorities intend to take a pragmatic approach to issues such as authorising clinical trials and issuing UK marketing authorisations based on existing EU authorisations after the implementation period.
The published guidance includes:
- Guidance on what the implementation period means for the life science sector (link);
- Technical information on the implementation period (link); and
- An update on the new EU Clinical Trial Regulation during the implementation period (link).
What are the key points in the new guidance?
The guidance confirms that life sciences companies will continue to be able to operate as currently. In particular, during the implementation period:
- EU marketing authorisation holders and qualified persons (QP) can continue to be located in the UK;
- The EU will continue to recognise UK marketing authorisations, manufacturing and distribution licences, GMP inspections, batch release testing and QP certification (and visa versa);
- Pharmacovigilance activities of EU marketing authorisation holders can continue to be based in the UK, including the location of the qualified person for pharmacovigilance (QPPV) and of the pharmacovigilance master file (PSMF);
- Labelling requirements will remain unchanged and multi-country packs for medicinal products will continue to be valid in both the UK and EU;
- The EU will continue to recognise medical devices that have been CE marked by a manufacturer in the UK and devices that have been assessed by a UK notified body (and vice versa); and
- The UK will continue to be treated as an EU Member State for the purposes of international agreements, including Mutual Recognition Agreements.
However, although UK companies will continue to be able to use both the EU centralised and decentralised procedures for marketing authorisations, the MHRA will no longer be able to act as the lead authority (Reference Member State) for the assessment of these applications. In particular, the guidance flags that companies should consider the expected conclusion date for applications submitted through the decentralised procedure, as the EU does not currently permit transfers of the appointed Reference Member State before the conclusion of the application process.
The status of new EU Regulations
The new EU Clinical Trials Regulation is expected to come into effect during the implementation period, and will apply in the UK during this period as part of EU law. The new Regulation streamlines the application process for multi-site clinical trials in the EU and simplifies reporting procedures. If the new Regulation does not come into effect during the implementation period, the UK Government has confirmed that it still intends to implement the Regulation into UK law as far as possible. The Guidance recognises that the UK’s participation in EU clinical trial systems after the implementation period will be subject to negotiation with the EU. If the UK is unable to negotiate continued participation in this system, the guidance reassures companies that the UK will put in place a streamlined and efficient approval process for UK clinical trials.
The new EU Medical Device Regulation (MDR) will apply fully from May 2020 (i.e. during the implementation period) and so will apply directly in the UK. The new EU In-vitro Diagnostic Medical Device Regulation (IVDR) only applies fully from May 2022, i.e. after the implementation period. The guidance reminds companies that IVDs which are in conformity with the new IVDR have been permitted on the market since May 2017 under the new regime, suggesting that this will continue to be the case following the implementation period.
Authored by Julia Fraser and Jane Summerfield