The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled a new corporate plan that aims to create a faster and more predictable regulatory environment.

The plan assigns the agency’s agenda to four key strategic priorities, which are further split into multiple milestones over a three-year span. This includes a focus on public trust, improved access to safe and effective products and the pursuit of new strategic partnerships, based on the 4 July announcement.

As part of the corporate plan, the MHRA plans to create faster risk-proportionate regulatory pathways that will support innovation in areas such as artificial intelligence, cell therapy and vaccines, per a document detailing the plan.

In the first year, the MHRA aims to launch an improved regulatory management system that will streamline its services and increase the use of self-service. The agency also seeks to optimise service delivery times in priority areas in the second year. Finally, the regulator wants to change the regulation of generic medicines by building on pre-defined criteria to address new goals, such as by considering sustainable medicines through green chemistry, in the plan’s third year.

Additionally, the MHRA wants to pursue strategic partnerships to develop new regulatory practices. This will include the introduction of the MHRA Science Strategy that builds on national and international partnerships in priority areas during the plan’s first year. The agency plans to contribute to the UK’s pandemic preparedness by building on past experience from the Covid-19 pandemic between 2024 and 2025, which will also include further collaborations with international regulators on a sustainability strategy.

The plan’s emphasis on the maintenance of public trust features multiple initiatives, which include a pilot of public hearings on major safety issues that will take place in 2024 and 2025. Additionally, the MHRA aims to finish the Yellow Card biobank pilot, which was announced in May and is currently looking at two particular drug safety issues over two years. This will help in the development of a business model that will be rolled out for all medicines and vaccines to understand the role of genetics in causing adverse reactions.

The MHRA also wants to further develop its work and customer service culture as the plan’s fourth priority. This includes attracting new talent, as well as making the agency a more diverse and equal workplace.

Reference：https://www.pharmaceutical-technology.com/news/mhra-corporate-plan-drug-regulatory-uk/