United Kingdom: MHRA Issues Guidance for Clinical Trials Post-Brexit Transition Period
September 1, 2020
On September 1, 2020, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) issued the following guidance documents related to clinical trials after the Brexit transition period ends on December 31, 2020:
- Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021
- Guidance on substantial amendments to a clinical trial from 1 January 2021
The ClinRegs team will review these new guidelines and update the UK profile where appropriate.
For details on all of UK's clinical research regulatory requirements, view the country profile.