UK Supports End-To-End Management Of Trials Undergoing Combined Reviews
Ongoing efforts by the UK to deliver a single decision on the ethical and regulatory approval of new clinical trial applications have reached a major milestone ahead of the 2022 mandatory deadline.
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The UK Health Research Authority (HRA) has partnered with an international clinical trials registry to make it easier for sponsors and researchers to comply with the mandatory requirement of registering their studies in an established public database within a specific time frame.
The UK says its initiative to unilaterally register clinical trials when they are given a research ethics committee approval will make it easier for trial sponsors to comply with their transparency requirements.
Having gained enough experience with the combined ethics and regulatory review of clinical trial applications, the UK will make this its only route for evaluating new drug trial applications starting next year.