The drug regulatory authorities of Switzerland, the Republic of Korea and Singapore have become the first three countries to be listed as WHO-Listed Authorities (WLA) that can be used as a point of reference for other countries’ deliberations on approval of new drugs and vaccines.

The WHO’s recently established WLA framework is intended to create an evidenced-based pathway for regulatory authorities operating at an advanced level of performance to be globally recognized.

The overall aim is to provide a point of reference for other national authorities in their consideration of new drugs for approval. This can help promote faster and more robust regulatory reviews in other countries of new, and potentially significant medical products that some national authorities may not have the resources to evaluate thoroughly on their own.

Traditionally, WHO as well as many low-and middle-income countries looked to the regulatory decisions of the US Food and Drug Administration (US FDA) or the European Medicines Agency (EMA) for guidance in their own national approval of new drugs and medicines.

However, the reference to the US FDA and EMA has always been informal and relatively ad-hoc.

WLA label creates a more systematic pathway for international recognition

The newly created WLA label aims to correct this by creating a more systematic pathway to international recognition for a national regulatory agency. That should signal to other countries that the agency meets WHO and other internationally recognized regulatory standards and practices.

A technical advisory group on WHO-Listed Authorities (TAG-WLA), which met for the first time in September at WHO headquarters in Geneva, made the designations based on a set of criteria established for the WLA framework. The group’s key task is to provide independent, strategic, and technical advice to the WHO as it decides who to add to the WLA. The group has 14 members from the six WHO regions with a broad range of expertise.

Asked by Health Policy Watch why the FDA and EMA hadn’t been granted certification yet, a WHO spokesperson said, “several stringent regulatory authorities (SRA) already initiated discussions with WHO on the process towards WLA.”

But the spokesperson added, “The decision to apply for evaluation and listing as a WLA is voluntary, and no selection is conducted by WHO; rather, it is initiated by or on behalf of the regulatory authority (RA) if satisfies one of the criteria.” They are:

• The RA is on the list of transitional WLAs (tWLA).
• The RA has attained at least overall Maturity Level (ML) 3 as determined through a formal benchmarking against the WHO Global Benchmarking Tool (GBT).

“Once eligibility is confirmed, the RA must undergo a performance evaluation process,” the spokesperson added, noting that the process is further described in a new Operational Guidance.

WLA designation applies to medicines, not medical devices

The WLA framework is currently only applicable to medicines [including multisource (generics), and new medicines (new chemical entities) and/or biotherapeutics and/or similar biotherapeutic products], and vaccines. Medical devices, including in vitro diagnostics, as well as blood and blood derivatives are not in the scope of the WLA, WHO said.

The newly WHO-certified authorities include the Health Sciences Authority (HSA), Singapore; the Ministry of Food and Drug Safety (MFDS), Republic of Korea; and the Swiss Agency for Therapeutic Products (Swissmedic), Switzerland. The listing indicated that the regulatory authority has complied with all the indicators and requirements specified by WHO.

“This achievement is the result of investment by the Governments of the Republic of Korea, Singapore and Switzerland in the strengthening of their regulatory systems and reaffirms the collaboration between WHO and the three Governments in promoting confidence, trust and further reliance on authorities that have attained this global recognition, through the transparent and evidence-based pathway for designating and listing of WLAs,” said Dr Yukiko Nakatani, assistant director-general for Access to Medicines and Health Products.

Although the WLA designation will provide a pathway for other countries in deliberating regulatory decisions, the WHO spokesperson  stressed that “the ultimate responsibility and decision for using or adopting the regulatory decisions taken by a WLA resides with the users (e.g., other regulatory authorities, procurement agencies) and will depend on the specific context and scope of its intended use.”

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