World Health Organization (WHO) announces that the Ministry of Food and Drug Safety, Republic of Korea, has achieved maturity level four (ML4), the highest level in WHO’s classification of regulatory authorities for medical products. WHO has formally assessed the medical product regulatory authorities of 33 countries, of which only the Republic of Korea is listed as attaining this level in regulation for both locally produced as well as imported medicines and vaccines.
This achievement represents an important milestone for the Republic of Korea and for the world, signifying that the Ministry of Food and Drug Safety (MFDS), the national regulatory authority for medicines and vaccines, is operating at an advanced level of performance with continuous improvement.
“This achievement by the Republic of Korea is great news for the broader Region and beyond. They are the first country in the world to be assessed by WHO and recognized as having achieved the highest level for both vaccines and medicines regulation,” said Dr Zsuzsanna Jakab, WHO Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office. “We highly appreciate the support already provided by the Republic of Korea to several other countries in strengthening their oversight of vaccines and medicines. Its role during the COVID-19 pandemic in supplying countries with quality assured vaccines and in vitro diagnostics has been well recognized.”
“It is a great honour to accept WHO’s confirmation that the Ministry of Food and Drug Safety is operating at maturity level four for vaccines and medicine regulation, based on WHO’s recent independent and objective assessment with the Global Benchmarking Tool,” said Dr Oh Yu-Kyoung, Minister, Ministry of Food and Drug Safety, Republic of Korea. “This achievement is a significant milestone for the Republic of Korea, as the first WHO Member State which has reached this highest maturity level for a regulatory system in both vaccines and medicines, to further contribute to the global public health. The Ministry of Food and Drug Safety will continue to strengthen close collaborations with the WHO in sharing its experience of establishing advanced level of regulatory system and supplying safe and high-quality medicines and vaccines.”
Only about 30% of the world’s regulatory authorities have the capacity to ensure medicines, vaccines and other health products are produced to required standards, work as intended and do not harm patients. WHO’s benchmarking efforts identify regulatory authorities that are operating at an advanced level so that they can act as a reference point for regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight.
“This is a great testament for Republic of Korea’s commitment for ensuring safe and effective medicines and vaccines, and investing in building a strong regulatory system,” said Dr Mariângela Simão, Assistant Director-General, Access to Medicines and Health Products. “We hope the achievement will be sustained and also help promote confidence, trust and further reliance on national authorities attaining this high level”.
Republic of Korea achieved ML4 for medicines and vaccines following a WHO benchmarking conducted in the country in May 2022, and working closely with WHO to implement the recommendations made by the its team of international regulatory experts.
WHO’s assessment of regulatory authorities is based on the “Global Benchmarking Tool” – an evaluation tool that checks regulatory functions against a set of more than 260 indicators. The indicators include review of core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse effects in order to establish their level of maturity and functionality.
In addition to the Republic of Korea, Singapore has attained ML4 in medicines regulation and 11 countries have attained ML3. Countries with ML3 and ML4 are eligible to become a WHO listed authority (WLA), following a further performance evaluation. The WLA is a new scheme for designating regulatory authorities that may be considered as a reference point by other regulatory authorities for reaching own decisions in approving medical products.
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