The Republic of Korea has reached the highest level of the World Health Organization for the regulation of drugs and vaccines

The World Health Organization (WHO) announces that the Ministry of Food and Drug Safety of the Republic of Korea has achieved Maturity Level Four (ML4), the highest level in WHO’s classification of regulatory bodies for medical products. WHO has officially assessed regulatory authorities for medical products in 33 countries, of which only the Republic of Korea is listed as having reached this level of regulation for both locally produced and imported drugs and vaccines.

This achievement represents an important milestone for the Republic of Korea and the world, signifying that the Ministry of Food and Drug Safety (MFDS), the national drug and vaccine regulatory authority, is operating at an advanced level of performance with continuous improvement.

“This achievement by the Republic of Korea is great news for the wider region and beyond. They are the first country in the world to be assessed by WHO and recognized as having achieved the highest level of regulation for both vaccines and medicines,” said Dr Zsuzsanna Jakab, WHO Deputy Director-General and Chief Regional Officer for the Western Pacific Region. Office. “We greatly appreciate the support that the Republic of Korea has already provided to several other countries in strengthening the surveillance of vaccines and drugs. Its role during the COVID-19 pandemic in supplying countries with vaccines and in vitro diagnostics of guaranteed quality is well recognized.”

“It is a great honor to accept WHO’s confirmation that the Ministry of Food and Drug Safety is operating at the fourth maturity level for vaccine and drug regulations, 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 World Health Organization member state to reach the highest level of regulatory system maturity for both vaccines and drugs, to further contribute to global public health. The Ministry of Food and Drug Safety will continue to strengthen close cooperation with the World Health Organization (WHO) in sharing experience in establishing an advanced level of regulatory system and supply of safe and high-quality drugs and vaccines.”

Only about 30% of the world’s regulatory bodies have the capacity to ensure that medicines, vaccines and other health products are manufactured to the required standards, work as intended and do not harm patients. WHO’s benchmarking efforts identify regulatory bodies that operate at an advanced level so that they can act as a reference point for regulatory bodies that do not have the resources to perform all the necessary regulatory functions or that have not yet reached a higher level of maturity for the oversight of medicinal products.

“This is a great testament to the Republic of Korea’s commitment to providing 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 Healthcare Products. “We hope that this achievement will be sustained and help promote confidence and further reliance on national bodies to achieve this high level”.

The Republic of Korea has achieved ML4 for medicines and vaccines following a WHO benchmarking study carried out in the country in May 2022 and close cooperation with WHO to implement recommendations made by its team of international regulatory experts.

WHO’s assessment of regulatory bodies is based on “A global tool for comparative analysis” – an evaluation tool that checks regulatory functions against a set of more than 260 indicators. Indicators include a review of core regulatory functions such as product authorisation, product testing, market surveillance and the ability to detect adverse effects to determine their level of maturity and functionality.

Along with the Republic of Korea, Singapore achieved ML4 in drug regulation and 11 countries achieved ML3. Countries with ML3 and ML4 are eligible to become a WHO Listed Authority (WLA), after further performance assessment. The WLA is a new scheme for designating regulatory authorities that can be considered a reference point by other regulatory authorities for making their own decisions in the approval of medicinal products.

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Notes to editors

the results global benchmarking evaluation are presented as maturity levels on a scale of 1 to 4. More information is available here.