WHO’s new scheme to globally recognize regulatory authorities

The World Health Organization recently announced a list of regulatory agencies from 56 countries that will undergo rigorous assessments in the next five years. The goal: to potentially be part of a new list that recognizes national regulatory authorities with the capability to ensure quality and safe medicines and vaccines. The WHO-listed authority, or WLA, is envisioned to become the new Stringent Regulatory Authorities list, which many international organizations have long relied on for the procurement of quality-assured and safe medicines and vaccines. The SRAs are part of many international organizations’ procurement policies. The Global Fund to Fight AIDS, Tuberculosis and Malaria’s quality assurance policy, for example, requires that medical products procured using Global Fund grants should be prequalified by WHO or approved by an SRA. During the COVID-19 pandemic, the Asian Development Bank also included this as one of the criteria for countries wishing to unlock financing from its $9 billion vaccine access facility to purchase COVID-19 vaccines. However, in recent years, WHO member states have asked the agency for a change, allowing for other national regulatory authorities to also be considered in such a “gold standard” list, and to launch a comprehensive and transparent process on how to reach that level of authority. This gave birth to the WLA concept. Currently, no country is classified as a WLA, even those considered as Stringent Regulatory Authorities. But the 56 countries that make up the transitional WLA list that WHO announced last week are expected to move a step closer to reaching the WLA designation. “They will have five years until [the] 31st of March 2027 to complete the performance evaluation process [to become WLA],” Dr. Rogério Gaspar, director of regulation and prequalification at WHO, told Devex. How to become WLA Countries that want to be designated as WLA will have to go through a performance evaluation process. But first, they need to have a regulatory system that has reached maturity level 3, or ML3, which WHO defines as national regulatory authorities with “stable, well-functioning and integrated regulatory systems.” “It's all about empowering regulatory authorities to ensure that the medicines they authorize, the vaccines they authorize are up to the right standard. --— Daniela Bagozzi, senior communication manager on access to medicines, vaccines, and pharmaceuticals, WHO To be classified as ML3 for vaccines or medicines, countries need to undergo a formal process evaluating the functionality of their regulatory systems using WHO’s Global Benchmarking Tool. The tool, also known as GBT, was launched in 2016 and replaces all of WHO’s previous assessment tools related to countries’ regulatory functions. It helps determine whether a country’s regulatory system is mature enough to guarantee quality-assured and safe medical products, or needs further improvements, and where such improvements are needed. At the moment, there are only nine countries classified as having a maturity level 3, with six of them limited to vaccines, and four limited to medicines and imported vaccines. WHO last week announced Egypt has reached ML3 status for vaccines, both for locally produced and imported ones, and Nigeria for medicines and imported vaccines. “When these countries start producing vaccines, WHO will undertake [an] abridged assessment for the additional requirements and regulatory areas, e.g. testing and lot release of vaccines,” Dr. Gaspar said. Meanwhile, only Singapore has achieved maturity level 4 across the world, making it a prime candidate for the WLA designation. All countries will have to go through a performance evaluation process to be considered for WLA, including those under the SRA list, although Gaspar said for some of the SRA countries, the process may just be a “light audit.” “All of them have to go through the PEP, the performance evaluation process. Of course, the process will be different according to the pre-existing level of performance of the regulatory systems … it's not a same-model-fits-all,” he said. WHO will be conducting a pilot phase following the launch of the transitional list of WLAs, and assess whether further adjustments are needed to its performance evaluation process. Countries previously considered as “functional NRAs,” such as China for example, also need to undergo formal assessments under the GBT before they can begin the process for WLA. Gaspar said China has engaged with WHO to undergo the official evaluation under the GBT during the summer of 2022 to become ML3 for vaccines, although not yet for medicines. “Politically, China decided not to engage yet with us in terms of being ML3 for medicines, and this pertains to the fact that the regulatory system for medicines is very fragmented in the provinces, with lack of central coordination. This is a political choice [by] the member state that we have to respect,” he said. What’s the significance of being a WLA? The WLA process is voluntary, meaning countries can opt not to be evaluated or be part of it. But there are several advantages to becoming a WLA, according to Dr. Gaspar. The process for WHO prequalification of medical products is “much more streamlined” for countries whose national regulatory authorities are designated as WLA, Dr. Gaspar said. This is an attractive option for countries with manufacturing capabilities for medicines and vaccines. In addition, they can become “reference countries,” meaning their evaluations can be considered by another regulatory authority from the region or a neighboring country when making its own decisions about a medical product. Products manufactured in countries that are under this new list can also be prioritized by procurement agencies as well, although that’s not automatic and the decision will rely on individual procurement agencies. Most importantly, WHO says the WLA process helps promote confidence, trust, and reliance in national regulatory authorities and creates a pathway for countries to strengthen their regulatory systems, which is key to ensuring their citizens’ access to lifesaving medical products. This has become even more relevant in the response to COVID-19 and as the world considers ways to prepare for future pandemics. “There's this strong agenda on global health security that needs — as one of the pillars — distributed manufacturing of medicines, vaccines, diagnostic kits … medical devices and also personal [protective] equipment [or] PPEs. And in order to have that distributed manufacturing capacity, you need to have that regulatory oversight,” Dr. Gaspar said. “This whole process is capacity building,” added Daniela Bagozzi, senior communication manager on access to medicines, vaccines, and pharmaceuticals at WHO. “It's all about empowering regulatory authorities to ensure that the medicines they authorize, the vaccines they authorize are up to the right standard so that they actually treat people, prevent illness, [and] test properly … So it’s not like just WHO saying you're good [or] you’re bad,” Bagozzi said.