Insights

UK's Regulator Announces Its Top Priorities in the Lead Up to Brexit

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's pharmaceutical and medical devices regulator, has recently released its 2017-2018 business plan. Of the 10 key priorities identified by the MHRA, life sciences companies will be particularly interested in the regulator's proposed strategy in the lead up to Brexit as well as how it intends to approach the regulation of medicines and medical devices in the UK in the interim period. In this respect, it is encouraging that the UK regulator's priorities emphasize the need for ongoing cooperation with EU regulatory procedures as well as developing, in parallel, an innovative world class, financially stable, regulatory offer based around more rapid and agile assessments. The MHRA plays a central role in medicines approvals for Europe (in 2015-2016, it was the reference EU Member State authority responsible for 43 percent of all decentralized MA applications in which applicants sought a UK authorization) and so its continuing involvement in this area is welcome.

The MHRA also announced a series of measures aimed at supporting innovation and improved access. These include implementing the recommendations of the Accelerated Access Review, a recent UK government initiative aimed at providing patients quicker access to innovative new diagnostic tools, treatments, and medical technologies, as well as supporting the Early Access to Medicines Scheme which provides expedited access to medicines that address unmet medical need. The MHRA also plans to expand its work on Big Data including further developing the Clinical Practice Research Datalink, an observational data and interventional research service, as well as working more closely with the U.S. FDA on the evaluation of real world evidence under the 21st Century Cures Act. There are also a number of proposals regarding improved vigilance activities, with particular emphasis on using digital technologies.

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