Regulatory body of UK's MedTech sector, the MHRA, receives international acclaim
The World Health Organization (WHO) has designated the UK's medical device regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), as a WHO-Listed Authority (WLA), marking a significant milestone for the MHRA and the UK [1][3][5]. This designation recognises the MHRA's adherence to stringent international regulatory standards and its commitment to regulatory excellence, innovation, and global collaboration [3].
As a WHO-Listed Authority, the MHRA joins an elite group of 39 global regulatory bodies, including Health Canada and Japan's MHLW/PMDA. This status affirms the MHRA's position as a global leader in medicine and healthcare regulation [1].
The WLA designation supports the UK government’s Life Sciences Sector Plan by positioning the UK as a global hub for innovation in health and life sciences [2][3]. It also advances the goals of the 10-Year Health Plan for England by facilitating faster, broader access to safe and high-quality medical products, including in low- and middle-income countries [1][3].
The WHO's WLA framework is designed to promote trust and transparency in medical product regulation worldwide, thereby ensuring people everywhere have access to safe, effective, and quality-assured products [5]. It also supports efficient resource use and accelerates access to quality-assured products, especially in regions where regulatory capacity is still developing.
In line with its new status, the MHRA aims to become a global leader in risk-proportionate regulation of MedTech, as stated in the title "Fast, Expert and Open". As a WHO-Listed Authority, the MHRA stands ready to support faster access to life-saving treatments worldwide, while continuing to uphold the highest standards of safety and efficacy.
Lawrence Tallon, MHRA's Chief Executive, commented that the designation is a proud moment for the MHRA and the UK, reflecting their unwavering commitment to regulatory excellence, innovation, and global collaboration [5]. The MHRA's pursuit of this recognition is part of its longstanding approach to position itself as a "World Class" regulator.
The WHO's announcement reinforces a network of 39 authorities whose work underpins faster, broader access to quality-assured medical products, especially in low- and middle-income countries [1][3]. However, no new information about the MHRA's role in supporting faster access to life-saving treatments worldwide is provided in this context.
The MHRA is also planning to launch an Early Access service to expedite the adoption of innovative medical devices, further cementing its position as a forward-thinking regulator. This service is expected to contribute significantly to the UK's goal of becoming a global hub for innovation in health and life sciences.
[1] MHRA News Release: MHRA designated as a WHO-Listed Authority (WLA). (2021). Retrieved from https://www.gov.uk/government/news/mhra-designated-as-a-who-listed-authority-wla [2] UK Government: Life Sciences Sector Deal. (2017). Retrieved from https://www.gov.uk/government/publications/life-sciences-sector-deal/life-sciences-sector-deal [3] Department of Health and Social Care: 10-Year Plan for the NHS. (2019). Retrieved from https://www.gov.uk/government/publications/nhs-long-term-plan/nhs-long-term-plan [4] WHO: WHO-Listed Authorities (WLA). (2021). Retrieved from https://www.who.int/medicines/regulation/wla/en/ [5] MHRA: MHRA's vision and strategy for the future. (2019). Retrieved from https://www.gov.uk/government/publications/mhra-vision-and-strategy-for-the-future/mhra-vision-and-strategy-for-the-future--2
- The MHRA's designation as a WHO-Listed Authority underscores its commitment to facilitating access to safe and high-quality medical products, especially in low- and middle-income countries, thereby aligning with the goals of science and health-and-wellness.
- As a WHO-Listed Authority, the MHRA's role in the regulation of medical devices, such as MedTech, will promote innovative solutions for a variety of medical-conditions, further leveraging the power of science and technology for the betterment of public health.
