The WHO announced in November that the Ministry of Food and Drug Safety (MFDS), Republic of Korea, achieved maturity level 4 (ML4) in its ranking of regulatory authorities for medical products. This is the highest level. Out of 33 countries assessed, only the Republic of Korea was listed as securing this level of regulatory recognition.  

Important milestone 

WHO described the occasion as an “important milestone” for both the Republic of Korea and the world. It signifies that the MFDS is “operating at an advanced level of performance with continuous improvement”. Dr Zsuzsanna Jakab, WHO Deputy Director-General and Office-in Charge of the Western Pacific Regional Office, received the “great news”, remarking that the Republic of Korea is the “first country in the world to be assessed by WHO and recognised as having achieved the highest level for both vaccines and medicines regulation”.  

Dr Oh Yu-Kyoung, Minister, MFDS, stated that it was a “great honour” to receive confirmation of the WHO’s recognition.  

“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.”  

The rest of the world  

WHO suggests that “only about 30%” of the regulatory authorities across the globe have the “capacity to ensure” that health products are “produced to required standards, work as intended, and do not harm patients”.  

The benchmarking efforts shine a spotlight on advanced regulatory authorities to set an example for others that “lack the resources to perform all necessary regulatory functions”. Based on the “Global Benchmarking Tool” the assessment revealed that 11 other countries have attained ML3, and Singapore has attained ML4 in medicines regulation. 

“Countries with ML3 and ML4 are eligible to become a WHO listed authority (WLA), following a further performance evaluation.” 

The WLA is a scheme for “designating regulatory authorities” as reference points for others to support them in decision-making.  

We will hear more on the various regulatory processes involved in vaccine development and distribution at the World Vaccine Congress in Washington next year. To join us, get your tickets now.