Regulations & EHS&S

MHRA issues 5-year post-Brexit plan

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a five-year corporate plan for 2018 to 2023 that highlights how the agency plans to address earlier outlined challenges from its last corporate plan period as well as what it labels as its most significant challenge, the UK’s exit from the European Union.

The agency says the negotiations on the UK’s exit from the EU will be a significant factor in the early stages of this newest corporate plan period. The exact nature of the agency’s relationship with EU regulators after exiting the EU will be determined through the negotiations, but it is the government’s intention to retain a close working partnership with both EU and other global regulators in the interest of ensuring patients continue to have timely access to safe medicines and medical innovations. In common with organizations throughout the UK, the agency says it will continue to prepare for all scenarios, including the very unlikely scenario in which no mutually satisfactory agreement can be reached and the UK exits without a deal.

While the agency says there will be some uncertainty in the early part of the corporate plan period, it also identified some points of clarity that it says will help as it progresses toward the operating environment after exiting the EU. These points include clear precedents for strong collaborative regulatory working between the EU and non-EU partners as well as the importance of global standards and global inspection efforts, which the agency says are core components of its contribution to public health protection.

Overall, the agency says it is setting out to build on action and achievement in the last corporate plan period (2013-2018) by retaining five areas and turning them into clear objectives. These objectives include: (1) protect public health and promote patient safety by ensuring the safety, efficacy and quality of medicines and healthcare products, including through enhanced partnerships in the UK and internationally; (2) support and enhance innovation and accelerate routes to market to benefit public health and be a magnet for the life sciences; (3) deliver robust, proactive integrated vigilance for medicines and healthcare products and improve the way the agency shares information to achieve measurable public health benefit; (4) ensure the safe production and supply of medicines and healthcare products through enhanced systems and strong international partnerships; and (5) be an exemplar of organizational excellence and efficiency.

The plan continues to list contents of the operational parts of the corporate plan and the complete detailed operational corporate plan with specific actions, activities, and projects set out to deliver the five objectives. It further breaks down the goals into 14 operational components, including exploring actions to develop processes and information-technology solutions that allow the agency to draw on information to inform market surveillance action.