International acclaim for the British Medical and Healthcare Regulations Authority (MHRA) in the field of MedTech regulation
The World Health Organization (WHO) has designated the UK's Medicines and Healthcare products Regulatory Agency (MHRA) as a WHO-Listed Authority (WLA), marking a significant milestone in global healthcare regulation. This recognition places MHRA among an elite group of 39 advanced regulatory authorities worldwide, such as Health Canada and Japan's MHLW/PMDA [1][2].
Seeking this recognition is part of the MHRA's longstanding approach to position itself as a "World Class" regulator. The WLA designation is in recognition of its commitment to regulatory excellence, innovation, and global collaboration [3]. This status affirms MHRA's adherence to the highest international regulatory standards, enhancing global trust and facilitating faster, broader access to quality-assured medical products, especially benefiting low- and middle-income countries [1][2][3].
The WHO's WLA initiative promotes trust, transparency, and global collaboration, enabling regulatory agencies like MHRA to contribute significantly to public health by ensuring high-quality medical products are accessible worldwide, thus advancing the WHO’s goal of accelerating access to safe and effective medicines globally [3][4].
The MHRA's Chief Executive, Lawrence Tallon, commented that this designation is a proud moment for the MHRA and the UK, reflecting their unwavering commitment to regulatory excellence, innovation, and global collaboration. 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 [5].
The WLA framework supports efficient resource use and accelerates access to quality-assured products, especially in regions where regulatory capacity is still developing [2]. This designation aligns with the UK government's strategic ambitions for life sciences innovation and healthcare transformation, supporting priorities in the Life Sciences Sector Plan and the 10-Year Health Plan for England aimed at improving patient access to safe, effective, and innovative treatments [1][2][5].
The WHO's United Nations' agency for promoting global health, has announced the MHRA as one of the newly appointed WLAs, alongside Health Canada and Japan's MHLW/PMDA [1]. The WHO's WLA framework plays a vital role in strengthening global regulatory systems, promoting convergence, and enabling reliance on trusted authorities.
[1] Medicines and Healthcare products Regulatory Agency
[2] World Health Organization
[3] WHO-Listed Authorities
[4] WHO's Goal of Accelerating Access to Safe and Effective Medicines Globally
[5] UK Government's Strategic Ambitions for Life Sciences Innovation and Healthcare Transformation
The MHRA's commitment to regulatory excellence, innovation, and global collaboration, as a WHO-Listed Authority, positions them to contribute significantly to public health by ensuring high-quality medical devices and products are accessible worldwide, in line with the WHO’s goal of accelerating access to safe and effective medicines globally. This designation supports the UK government's strategic ambitions for life sciences innovation and healthcare transformation, prioritizing improved patient access to safe, effective, and innovative treatments for various medical-conditions.
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