A new five-year corporate plan the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revealed Tuesday highlights how the agency intends to “become a real world regulator” and to “ensure a smooth EU exit under any scenario.”
By retaining the same five areas of improvement identified in the 2013–2018 plan
and turning these “into clear objectives” for 2018 through 2023, 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 UK and the EU.
According to MHRA, significant headway was made with the 2013–2018 plan, as required under its framework agreement with the Department of Health and Social Care, including strengthened global supply chains by extending international partnerships with India
and with China
The 2018–2023 plan—which was developed with both internal agency staff and external industry input over the past year—sets the stage for 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,” MHRA Chairman Sir Michael Rawlins said.
Following major efforts by regulators and industry across the world, MHRA also plans to expand its use of real-world data (RWD) to support regulatory decision making. As such, the plan involves using RWD as a base for regulations of pharmaceuticals and devices.
The 25-page document details how the five improvement areas will be tackled with different objectives for each one, and how this will be operationalized by the agency using the “specific actions, activities, and projects set out to deliver these five objectives,” MHRA said.
For example, the third objective—measuring public health benefit via proactive drug and device regulatory surveillance—is split into two goals: improving RWD use and enhancing information sharing. These are both assigned 14 different operational components, such as exploring the use of the services of Clinical Practice Research Datalink (CPRD) to improve vigilance activities.
Optimized use of CPRD data will allow MHRA “to become a real world regulator proactively monitoring medicine and medical devices safety in real time,” the agency said.
MHRA also recognizes there are remaining challenges that must be addressed as part of its five-year plans, with the ones identified for 2018 through 2023 being “no less demanding” than those dealt with in the past. Yet the remaining challenges “need to be address in circumstances of substantially increased uncertainty” over Brexit, the agency added.
The challenges to keep pace with technological and scientific advancements, such as genomics and artificial intelligence-driven products, include transforming end-of-life IT systems, as well as investing in staff recruitment and retention.
Brexit “Points of Clarity”
The agency 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.”
There may still be uncertainty at first, according to MHRA, as it moves to implement its new plan. But the “points of clarity that will help” throughout the UK’s exit process include the “clear precedents” for the regulatory work that has been done in collaboration between EU and non-EU partners, such as Switzerland and Turkey.
In the interest of public health, it also “makes sense for all parties” for regulatory network contributions from the EU to the UK and vice versa, to continue post-Brexit, due to the unique knowledge and expertise they both have to offer, according to MHRA.
Yet another point that MHRA believes speaks to future UK-EU collaborations for the purposes of regulating drugs and devices relates to “the growing importance of global standards.” Global regulatory harmonization and convergence “means that regulation of pharmaceuticals and devices is as much a globally-driven as a regional activity,” the agency said.
MHRA Corporate Plan 2018 to 2023