South Korea Becomes First Country to Achieve Highest Level in WHO’s Medicine And Vaccine Regulatory Assessment
01/12/2022 •
South Korea
South Korea becomes an ML4-designated country for medicines and vaccines regulations.

South Korea became the first country in the world to achieve the highest level, “maturity level 4” (ML4), in regulating medicines and vaccines. 

The Ministry of Food and Drug Safety (MFDS) in the Republic of Korea is the only national regulatory authority to be recognised by the World Health Organization (WHO) to have advanced oversight on locally produced and imported medicines and vaccines. The WHO had assessed 33 countries in total, of which only South Korea earned the highest accolade. 

WHO’s benchmarking on regulatory authorities offer a reference point on drug and vaccine regulation to countries that do not have the internal capacity to do so. Currently, only around 30% of the regulatory authorities across the world have the capacity to ensure that the medical products (drugs and vaccines) they produce meet the required standards, work as intended and do not cause harm in patients, the WHO said. 

“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,” Dr Zsuzsanna Jakab, WHO’s Deputy Director-General and Officer-in-Charge of the Western Pacific Regional Office said. 

The Republic of Korea’s regulatory authority was assessed by the WHO in 2022 and the MFDS worked closely with the agency in implementing the recommendations made by an international body of experts. 

The WHO’s assessment is based on the “global benchmarking tool”, a unified evaluation tool launched in 2019, which examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. Level 1 indicates the presence of some regulatory elements whereas level 4 indicates that the regulatory system is operating at an advanced level, with continuous improvements. 

Regulations
Global Benchmarking Tool – WHO

Apart from South Korea, Singapore is also designated at ML4 level for regulation of medicines. Ten other countries are at the ML3 level on WHO’s list. Countries at ML3 and ML4 levels are eligible to become a WHO listed authority, by which they can be considered a reference point by other countries’ regulators to decide on approving medical products. 

Image Credits: Photo by Muhammad Syafi Al – adam on Unsplash, World Health Organization.

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