WHO Expands List of Trusted Regulatory Agencies to 36, including US FDA and European Medicines Agency
World’s leading medicine agencies, including US Food and Drug Agency and European Medicine Agency have gained official WHO recognition as Listed Agencies

WHO has expanded its list of trusted national regulatory authorities from three to 36 agencies – including the United States Food and Drug Adminstration (FDA), the European Medicines Agency (EMA) as well as the European Medicines Regulatory Network (EMRN), composed of the European Commission, and thirty national regulatory agencies.

The WHO Listed Authorities (WLAs) are intended to reflect agencies that follow the highest level of regulatory standards and practices, for reviewing medicines and vaccines quality, safety and efficiency – and therefore can be used as guideposts for other countries to follow.

“With leading regulatory authorities joining our list, we are stronger and more united to improve access to quality, safe and effective medicines and vaccines for millions more people,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press briefing on Tuesday. 

He noted that the approval “covers all regulatory functions, including generics, new medicines, biotherapeutics and vaccines.”

The three previous agencies on the WLA included the Ministry of Food and Drug Safety of the Republic of Korea, the Swiss Agency for Therapeutic Products (Swissmedic) and Singapore’s Health Sciences Authority. The latter received a WHO sign of approval for an “expanded scope” of work “including all regulatory functions” in the recent round – the same level as the other 35 WLAs, Tedros said.

The initiative to create a register of WHO Listed Authorities was launched  in 2021 during the COVID pandemic when time-consuming regulatory reviews slowed some countries’ approvals of critical medicines and vaccines – particularly in low- and middle income countries. Earmarking the WLAs aimed to formalise the process whereby countries with fewer resources could follow the lead of other reputable drug agencies in their deliberations on the approval of new medicines and vaccines . 

The  first agencies – from Switzerland, Korea and Singapore – were granted the WHO WLA designation in late October 2023, as Health Policy Watch reported

WLAs Criteria and competences

To attain  the WLA designation, agencies need to apply to  the WHO-Listed Authorities Technical Advisory Group (TAG-WLA).

Applicants must already be listed as a Transitional WHO Listed Authority, reaching a maturity level 3 as per a set of Global Benchmarking Tools and other criteria. Next, the advisory group evaluates the agency’s  qualifications for a more advanced designation.

On the list itself, there is also a hierarchy of status. For instance, Singapore’s Health Sciences Authority (HSA) was designated as a WLA for some regulatory functions in the initial list of October 2023. But in the recent review,  it received WLA designation for an expanded scope of functions, including market surveillance and control. 

“As WLAs, these agencies can be relied on to reassure quality and safety of medicines and vaccines to streamline processes, optimize resources, and expedite access to medicines and vaccines,” Dr Yukiko Nakatani, WHO’s Assistant Director-General stated in a press release.

Attaining the WLA designation also means a commitment to continuous improvement and excellence in regulatory oversight: a quality the working group says EMRN, HSA and US FDA demonstrate, WHO said.

Meanwhile, the list of 36 agencies representing 34 countries may expand further, with several stringent regulatory authorities now pending evaluations, WHO said.

Image Credits: DNDi.

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