The notification scheme stems from the agency’s overhaul of rules announced in March, with the aim of making it “faster and easier” to gain approval and to run clinical trials in the UK – and elevate the country’s position in the global clinical research sector.
The new objective is to approve the lowest-risk phase 3 and 4 trials in less than 14 days, rather than the current statutory limit of 30 days, provided the sponsor can meet various criteria. For now, it does not apply to first-in-human, phase 1 and 2 studies, or amendments to an existing application.
