On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for registration of clinical trials for investigational medicinal products (IMP) and submission of substantial amendments.
From 01 Jan 2021 Sponsors will need to continue to register their trial on a publicly accessible database prior to the beginning of the study. If the trial involves both UK and EU sites, this will be possible via a record in the EU Clinical Trials Register. If it is a UK only trial, a register such as the ISRCTN registry should be used. Sponsors are also instructed to publish summaries of trial results within six months for paediatric 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, legal representative or when there are changes related to the certification and importation of investigational medicinal products. If the Sponsor of a UK trial is using IMPs imported from the approved list of EU countries, they will have 12 months from 01 Jan 2021 to ensure a GB (England, Scotland, Wales) Manufacturer/Import License (MIA) holder puts in place an assurance system to confirm each batch of IMP has been certified by a Qualified Person (QP) before it is used in the trial. Sponsors in this position will need to submit a substantial amendment to nominate a GB MIA holder to perform the supply chain oversight.
Information on importation if IMP for trials in Northern Ireland are not available yet.
For trials being conducted in the UK, the MHRA will continue to accept the Sponsor/Legal Representative being located in the UK or a country on the approved list of EU countries. For Rest of World Sponsors with a UK based Legal Representative, they must transfer this to an EU based Legal Representative if they have EU trial sites. This named position should be changed via submission of a substantial amendment to the relevant EU Competent Authorities. If the UK legal representative retains responsibility for the UK study, no amendment will need to be submitted to MHRA.
To view the guidance on registration of clinical trials, click here.
To view the guidance on substantial amendments, click here.