The latest guidance for investigational medicinal products details information pertaining to the registration of clinical trials, publishing trial results and future requirements if Brexit occurs.
Set to apply from exit day subject to the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 being passed, the guidance follows on from the further guidance note that was published on 3 January this year.
UK aims to align transparency provisions with those currently operating in the EU to eliminate the need for companies to duplicate efforts.
MHRA said in a statement: “In the short term, you should continue to use existing and established international registers such as EudraCT (EU), ISRCTN (International Standard Randomised Controlled Trial Number) register (UK), and ClinicalTrials.gov (USA) to ensure that UK patients are aware of your trial.”
The guidance further added that any approval by a research ethics committee in the UK is subject to the condition that all trials must be registered on a publicly accessible database within a period of six weeks from the recruitment of the first participant.
All clinical trials are expected to be registered, however, in exceptional circumstances, non-registration may be permissible with prior agreement from the Health Research Authority (HRA).
MHRA said that the UK will continue to make information about trials being conducted available to the public, patients, researchers and clinicians through the HRA website and UK Clinical Trials Gateway.
The summary of results needs to be posted within six months for paediatric clinical trials or within one year for non-paediatric clinical trials, at the end of the trial.