World Acclaim for the U.K.'s Medical Technology Regulator, the MHRA
The World Health Organization (WHO) has designated the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK as a WHO-Listed Authority (WLA), placing it among an elite group of 39 global regulatory bodies recognised for meeting the highest international standards in medical product regulation. This designation is a proud moment for the MHRA and for the UK, affirming the robust and trusted regulatory system of the MHRA.
The WLA status aligns with the UK's Life Sciences Sector Plan and the 10-Year Health Plan, reinforcing the MHRA’s role in accelerating access to quality-assured medical products and enhancing innovation in healthcare. As a WLA, MHRA helps enable faster access to safe, effective, and high-quality medical products not only within the UK but also especially in low- and middle-income countries through improved global regulatory convergence and reliance frameworks.
The designation of the MHRA as a WLA confers several key benefits and important implications. It provides international recognition for regulatory excellence, supporting the UK's strategic health and life sciences goals. The recognition fosters stronger global collaboration between regulators, manufacturers, and health systems by promoting transparency and aligning regulatory assessments, which can streamline drug approvals and supply. With the MHRA’s elevated status, it can expedite regulatory reviews and prioritise approvals to ensure medicine availability and patient safety, thus contributing to a more resilient supply of medicines domestically and internationally.
Seeking this recognition is part of the MHRA's longstanding approach to position itself as a "World Class" regulator. The MHRA stands ready to support faster access to life-saving treatments worldwide while continuing to uphold the highest standards of safety and efficacy.
In addition to the WLA designation, the MHRA is planning to launch an Early Access service to expedite the adoption of innovative medical devices. A stakeholder survey has been launched by the MHRA regarding the Medicines and Medical Devices Act 2021.
The article was prepared using AI. For comments or questions, please contact [email protected]. The MHRA's designation as a WHO-Listed Authority reflects the UK's unwavering commitment to regulatory excellence, innovation, and global collaboration. The WHO's WLA framework plays a vital role in strengthening global regulatory systems, promoting convergence, and enabling reliance on trusted authorities.
References:
[1] MHRA. (2021). MHRA Becomes a World Health Organization Listed Authority. [online] Available at: https://www.mhra.gov.uk/news/mhra-becomes-world-health-organisation-listed-authority
[2] WHO. (2021). WHO-Listed Authorities. [online] Available at: https://www.who.int/medicines/regulation/prequalification/wholisteds/en/
[3] GOV.UK. (2021). Life Sciences Sector Deal. [online] Available at: https://www.gov.uk/government/publications/life-sciences-sector-deal
[4] GOV.UK. (2021). 10-Year Plan for the NHS. [online] Available at: https://www.gov.uk/government/publications/10-year-plan-for-the-nhs
[5] MHRA. (2021). MHRA's Approach to Supply Chain Resilience. [online] Available at: https://www.gov.uk/government/publications/mhra-approach-to-supply-chain-resilience/mhra-approach-to-supply-chain-resilience
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