Broughton's Head of Regulatory Affairs, Lloyd Smart, has recently published an article with the leading sector publication, PharmTech.
The Medicines and Healthcare products Regulatory Agency (MHRA) is playing a fundamental role in ensuring that the United Kingdom remains one of the best places in the world to research and develop safe and innovative medicines. In August 2021, as part of a wider piece of work around clinical trials in the UK, MHRA launched new systems functionality to support the combined review of Clinical Trials of Investigational Medicinal Products (CTIMPs).
Highlights of selected legislative changes
In this article, Lloyd discusses the consultation on proposals for the future of UK clinical trial legislation and highlights selected legislative changes. To simplify and streamline applications, MHRA proposes a range of changes including:
- amendments in the request for information (RFI) process
- introduction of a notification scheme for low-intervention trials
- updated requirements for research ethics committees
- certain UK definitions
The article is available to read here.
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