The World Health Organization (WHO) announces that the Ministry of Food and Drug Safety of the Republic of Korea has reached maturity level four (ML4), the highest level in the classification of regulatory authorities for medical products of the WHO. The WHO has formally assessed the medical product regulatory authorities of 33 countries, of which only the Republic of Korea is listed as reaching this level of regulation for both locally produced and imported medicines and vaccines.
This achievement represents an important milestone for the Republic of Korea and the world, which means 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 Region as a whole and beyond. They are the first country in the world to be assessed by the WHO and recognized as having reached the highest level of vaccine and drug regulation,” said Dr. Zsuzsanna Jakab, WHO Deputy Director General and Officer in Charge of the Region. of the Western Pacific. Office. “We highly appreciate the support that the Republic of Korea has already provided to several other countries in strengthening their supervision of vaccines and medicines. Their 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 honor to accept confirmation from WHO that the Ministry of Food and Drug Safety is operating at maturity level four for vaccine and drug regulation, based on WHO’s recent independent and objective assessment with the Tool of global benchmarking,” 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 to have reached this higher level of maturity for a regulatory system for both vaccines and drugs, to further contribute to global public health. . The Ministry of Food and Drug Safety will continue to strengthen close collaboration with WHO to share their experience in establishing an advanced level of regulatory system and supplying high-quality and safe medicines and vaccines.”
Only about 30% of the world’s regulatory authorities have the ability to ensure that medicines, vaccines and other healthcare products are produced to required standards, work as intended and do not harm patients. WHO benchmarking efforts identify regulatory authorities that are operating at an advanced level so that they can act as a benchmark for regulatory authorities that lack the resources to perform all necessary regulatory functions, or have not yet reached higher maturity levels for monitoring medical products.
“This is a great testament to the Republic of Korea’s commitment to ensuring safe and effective medicines and vaccines, and investing in building a strong regulatory system,” said Dr. Mariângela Simão., Deputy Director General, Access to Medicines and Health Products. “We hope the achievement will stick and also help promote trust and further confidence in national authorities who achieve this high standard.”
The Republic of Korea achieved ML4 for medicines and vaccines following a WHO benchmarking conducted in the country in May 2022, and working closely with the WHO to implement the recommendations made by its team of international regulatory experts.
WHO’s assessment of regulatory authorities is based on the “Global Benchmarking Tool”, an assessment tool that compares regulatory functions against a set of more than 260 indicators. The indicators include the review of basic regulatory functions, such as product authorization, product testing, market surveillance and the ability to detect adverse effects to establish their level of maturity and functionality.
In addition to the Republic of Korea, Singapore has achieved ML4 in drug regulation and 11 countries have achieved ML3. Countries with ML3 and ML4 are eligible to become a WHO Listing Authority (WLA), following further performance assessment. The WLA is a new scheme for designating regulatory authorities that can be considered as a reference point by other regulatory authorities to make their own decisions on the approval of medical products.
Notes to editors
The results of the global benchmarking are presented as maturity levels on a scale of 1 to 4. More information is available here.