The Medicines and Healthcare Products Regulatory Agency (MHRA) has released a corporate plan for 2018 to 2023, which outlines the agency’s strategic direction over the next five years, including how to ensure a smooth European Union (EU) exit under any scenario.
The MHRA intends to use the new plan to address the uncertainty surrounding Brexit negotiations to reach a “deal” or “no deal” agreement on continuing relations between the United Kingdom (UK) and the European Union (EU). The new plan has retained the same five areas of improvement identified in the 2013-2018 plan, and the MHRA have subsequently turned these into objectives for 2018 through 2023.
The 2018 – 2023 plan, which was developed with internal agency staff and external industry input, aims to demonstrate how the agency will “take on the challenges which lie ahead of regulating new and innovative products and production methods as scientific advantages take use into new areas in medicines and medical devices, and of providing real-time benefit risk information”.
The 25-page document details how the five improvement areas will be addressed with different objectives for each one, and how this will be operationalised by the agency using the specific actions, activities, and projects set out to deliver the five objectives. The MHRA also plans to expand its use of real-world data (RWD) to support regulatory decision making therefore, the plan includes using RWD as a base for regulations of pharmaceuticals and devices.
With regards to Brexit, the MHRA is preparing for all scenarios, including the “very unlikely scenario in which no mutually satisfactory agreement can be reached and the UK exits without a deal.” The MHRA states that there may still be uncertainty at first as they move to implement their new plan. However, the “points of clarity that will help” throughout the UK’s exit process include the precedents for the regulatory work that has been done in collaboration between EU and non-EU partners, such as Switzerland and Turkey.
The MHRA states that in the interest of public health, it makes sense for regulatory network contributions from the EU to the UK and vice versa, to continue post-Brexit. Furthermore, a point that the MHRA believes speaks to future UK-EU collaborations for the intention of regulating drugs and devices relates to “the growing importance of global standards.” The agency states that global regulatory harmonisation and convergence “means that regulation of pharmaceuticals and devices is as much a globally-driven as a regional activity”.
To read the MHRA’s corporate plan for 2018 to 2023, please click here.