The World Health Organization (WHO) has designated government regulatory authorities in Canada, Japan, and the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national authorities that meet the highest international regulatory standards for medical products.

The recognition widens the pool of WHO-recognized authorities significantly beyond the previously recognized authorities in Europe, the United States and Singapore.

“WHO has designated national regulators in Canada, Japan and the United Kingdom as WHO-listed authorities, meaning they meet the highest international standards for regulation of medical products,” said Tedros at a briefing Thursday for Geneva UN press.

Additionally, the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) –  which had received partial WLA recognition in October 2023 – also had its listing scope expanded, so that the WHO recognition now covers all regulatory functions, Tedros said.

“Around 70% of countries worldwide still face significant challenges due to weak or inadequate regulatory systems for evaluating and authorizing medical products.  WHO-listed authorities play a pivotal role in ensuring more efficient use of limited resources, enabling faster access to quality-assured life-saving medical products to millions more people,” Tedros added saying, “This is an example of the unique role that WHO plays in strengthening national health systems.”

The WLA framework was established in 2022  to incorporate lessons leaned from the COVID-19 pandemic – where slow regulatory processes sometimes delayed approvals by low- and middle-income country regulators of vaccines or medicines that had already been cleared by stringent authorities elsewhere.  It paved the way for regulatory authorities, especially those in developing countries, to rely on the prior deliberations and decisions of other reputable regulatory agencies, in making their own decisions to approve new medicines, vaccines and medical devices. This helps facilitate more cost-effective and streamlined approval of life-saving medical products in countries with fewer resources and capacity to undertake extensive reviews, WHO says.

“The principle of reliance is central to WHO’s approach to regulatory systems strengthening and a cornerstone for effective, efficient and smart regulatory oversight of medical products,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “WHO-Listed Authorities are key enablers in promoting trust, transparency, and faster access to quality-assured medical products, especially in low- and middle-income countries.”

Effectively, the new approvals expands the base of WHO-listed authorities to which other countries can refer significantly beyond the traditional referral points of the US Food and Drug Administration (US FDA) and the European Medicines Regulatory Network, as well as Singapore (approved in 2024), to include both the UK and Canada, as well as more partners in Asia.

In parallel moves, the African Union and the African Centers for Disease Control have been supporting the operationalization of an African Medicines Agency, which could further harmonize and streamline medicines and vaccines reviews and approvals on the continent. In June, the head  of Ghana’s Food and Drugs Authority (FDA) Dr Delese Mimi Darko was appointed as the inaugural Director-General of the AMA at a Conference of State Parties (CoSP) in Rwanda.

See related AMA coverage here:

https://healthpolicy-watch.news/african-medicines-agency-countdown/

Image Credits: ©EC/ECHO/Anouk Delafortrie, Brian Otieno/ Global Fund.