International acknowledgment for the UK's medical devices authority, the MHRA
The World Health Organization (WHO) has designated the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) as a WHO-Listed Authority (WLA), signifying that the MHRA meets the highest international regulatory standards for medical product regulation. This recognition places the MHRA among an elite group of 39 global agencies that are trusted to ensure faster and broader access to safe, effective, and quality-assured medical products worldwide.
The WLA designation is a significant milestone for the MHRA, reinforcing its commitment to regulatory excellence, transparency, and innovation. The status replaces the older Stringent Regulatory Authority (SRA) system with a more transparent and evidence-based framework designed by WHO to facilitate regulatory convergence and reliance among countries.
The MHRA's WLA designation plays a crucial role in strengthening global regulatory systems, promoting efficiency, and accelerating access to quality-assured products. It supports the global health effort to speed up access to quality-assured medical products and helps maintain continuity and stability in international procurement processes.
The WLA framework supports efficient resource use and accelerates access to quality-assured products, especially in regions where regulatory capacity is still developing. The MHRA's WLA status, therefore, is particularly significant in low- and middle-income countries, where it can help improve access to life-saving treatments.
The MHRA's pursuit of WHO recognition is rooted in its longstanding strategy to establish itself as a "World Class" regulator. The agency's Chief Executive, Lawrence Tallon, commented that the designation is a proud moment for the MHRA and the UK.
With the MHRA's inclusion, the WHO's WLA framework continues to foster a network of trusted authorities, promoting global collaboration and regulatory excellence. The MHRA now stands alongside Health Canada and Japan's MHLW/PMDA as newly appointed WLAs. This designation positions the MHRA alongside respected authorities in the global medical device regulatory landscape.
The WHO's designation reinforces a network of 39 authorities, facilitating faster, broader access to quality-assured medical products worldwide. The MHRA, as a WLA, stands ready to support faster access to life-saving treatments worldwide while maintaining the highest standards of safety and efficacy. The designation is a testament to the MHRA's dedication to global regulatory systems, promoting convergence, and enabling reliance on trusted authorities.
Science plays a vital role in the MHRA's commitment to regulatory excellence, as it continually strives to innovate and upgrade its standards in line with the latest medical-conditions research. The MHRA's WLA designation, by fostering regulatory convergence and reliance among countries, can facilitate the faster and broader access to quality-assured health-and-wellness products worldwide, particularly in regions where regulatory capacity is still developing.
