Speed-to-market is the cornerstone of the 2020-2021 post-Brexit strategy for the UK Medicines and Healthcare products Regulatory Agency (MHRA), according to the agency’s business plan published 10 June 2020.
The UK left the European Union earlier this year but remains covered by its rules until the end of 2020. Unless the UK and EU agree to a delay by the end of June, the two parties will fully separate at the start of next year. Exactly how the separation happens will depend on whether a trade deal is reached; however, to some extent, MHRA will be free to plot a course as an independent regulatory agency.
In its business plan, MHRA sets out “three fundamental shifts” to how it plans to operate going forward. The first shifts is a “focus on UK patient access to highly innovative products, with oversight of safety and clinical impact from earliest (including ‘experimental’) use.”
To that end, one goal for the period is to “develop streamlined approaches to supporting innovation in medicines and medical devices, so that new products can come safely and more quickly to the UK market to the benefit of patients.” MHRA also plans to “develop a new compelling innovation offer” that encourages the development of new products for use in the UK…