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Drug Ministry looks to become 1st WHO-listed authority

July 28, 2022 - 15:20 By Kan Hyeong-woo
South Korea’s Minister of Food and Drug Minister Oh Yu-kyoung announces the ministry’s new approach in innovating regulations to help local firms’ globalization at the ministry on Thursday. (Ministry of Food and Drug Safety)
South Korea’s Ministry of Food and Drug Safety aims to become the first regulatory body recognized by the World Health Organization to hold globally recognized authority for granting domestic permits of new drugs by December, officials said Thursday.

Introduced earlier this year, the WHO-Listed Authority, or WLA, is the global organization’s initiative to certify a regulatory body as a globally recognized authority to replace the procurement-oriented concept of stringent regulatory authorities, according to the WHO. There are no WLAs at the moment.

In applying to become the first WLA, the Drug Ministry said it will look to secure recognition of domestic permits and support local biotechnology and health care firms to achieve exemption from extra quality certifications when exporting their products.

The Drug Ministry also announced a list of regulation changes to aid local firms developing next-generation technologies and drugs such as artificial intelligence, microbiomes, mRNA and viral vectors.

Under the current regulations, the authorities look into safety assessment standards and apply the existing restrictions only after a new product is granted an approval, delaying its market entrance.

The ministry said it will preemptively draft safety testing protocols and customized regulations before new products are approved, in order to help companies commercialize quicker than before.

The ministry vowed to cut down the number of trial and error cases by reviewing how the existing regulations can impact state-level research and development projects in the beginning stages.

As the health authority sector requires talented professionals, the ministry said the government will foster 17,000 experts in the regulatory fields for medicine, medical devices and food over the next five years.

The ministry emphasized its willingness to work with the private sector to innovate its regulations, and that it would announce a roadmap for innovating 100 regulations in August. The ministry also plans to hold a monthly meeting led by the minister of food and drug safety to go over the process of innovating regulations.

“The food and medicine industries, including bio(tech) and digital health, are future growth sectors where new technologies are expected to take the lead, and (the South Korean) industry is also facing a chance to take a leap towards global leadership,” said Oh Yu-kyoung, Minister of Food and Drug Safety, in a statement. 

“The Ministry of Food and Drug Safety will boldly innovate old regulations that cannot embrace products with a new concept so they can be on par with global standards and swiftly shift regulations to actively support the industry’s challenges and innovation.”