29 Aug EU’s Clinical Trial Regulation and Brexit
In March, the UK and EU negotiating teams reached agreement on the terms of an implementation period that will start on 30 March 2019 and last until 31 December 2020. During this time, the UK will no longer be a Member State of the European Union, but market access will continue on current terms.
The EU’s new Clinical Trials Regulation (CTR) specifically is expected to be implemented during 2020 and would apply to the UK under the terms of the time-limited implementation period.
If the EU’s CTR does not come into force during the implementation period, the UK government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, in order that researchers conducting clinical trials can plan with greater certainty.
If the UK is outside of the EU network following the end of the implementation period, it will still be possible for sponsors to run multinational trials involving the UK. Sponsors would have to apply to MHRA, as well as to the EU concerned states; but MHRA would take every effort to ensure this parallel submission is as streamlined and efficient as possible (for example by using the same application dossier). MHRA would also provide an assessment outcome no later than the European timeframe.
The current regulatory approval legislation will stay in place until such time as any changes are needed, so there will be no interruption in UK clinical trials approval (whether for academic or industry-led clinical trials).
The UK government has been clear on its preference for close cooperation with the EU across all aspects of medicines regulations. It is in the interest of patients and the Life Sciences industry internationally for the UK and EU to find a way to continue cooperation in the field of clinical trials, and for continued sharing of data, even if UK precise relationship with the EU will by necessity change.
Reference: https://www.gov.uk/government/news/clinical-trials-regulation
PharmaGCP frequently publishes relevant news in clinical research – you can get these news for free by following PharmaGCP on LinkedIn; https://www.linkedin.com/company/pharmagcp/
No Comments