UK – MHRA posts suite of post-transition guidances

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.
 
Clinical trials
 
Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial amendments to clinical trials.
 
Sponsors should continue using established international registers, including the ISRCTN registry or the US’s clinicaltrials.gov and instructions are provided for the timeframes for trial registration and registration deferral. Sponsors are also instructed to publish summaries of trial results within six months for pediatric studies and within one year for adult trials.
 
The guidance on substantial amendments explains when a substantial amendment is needed depending on the location of the trial sponsor or legal representative or when there are changes related to the certification and importation of investigational medicinal products. MHRA says it will provide details on a protocol for Northern Ireland “in due course.”…