Broughton's Chief Commercial Officer, Andy Mooney, discusses the latest synthetic nicotine legislation and what this means for ENDS manufacturers.
Pharmaceuticals
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.
To identify your next steps, contact us to book a meeting with our regulatory services team. If you’d like to learn more about regulatory pathways and how they create new business opportunities for forward-looking companies then read our recent Regulatory Digest below:
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