[Public Voices] The Significance of KFDA’s Selection as a WHO Listed Authority

On October 26, the World Health Organization (WHO) selected the Korea Food and Drug Administration (KFDA), along with regulatory agencies from Switzerland and Singapore, as WHO Listed Authorities (WLA). Through expert on-site inspections and evaluations in the relevant fields, WHO recognized the KFDA as an international model regulatory agency. This is the world's first listing on the WHO Excellent Regulatory Authorities list, covering eight functions in the fields of pharmaceuticals and vaccines: pharmacovigilance, manufacturing and import licensing, regulatory inspections, testing and analysis, clinical trials, national lot release, marketing authorization, and market surveillance. WHO established the WLA system to strengthen global health systems and achieve universal health coverage. The WLA is a list compiled by WHO that evaluates and recognizes regulatory agencies with outstanding regulatory systems and operational capabilities in pharmaceutical regulation.

An effective pharmaceutical regulatory system is crucial for the supply of safe and high-quality medicines. WHO, together with the Global Fund, has favored initial member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in international pharmaceutical procurement for humanitarian aid. As the ICH membership expanded in 2015, WHO needed to replace the preferential criteria based on ICH membership. The existing list of excellent regulatory authorities, SRA (Stringent Regulatory Authorities), includes regulatory agencies that joined ICH before 2015; since the KFDA joined ICH in 2016, it was not included in the SRA. Currently, WHO applies quality certification exceptions to SRA countries bidding for pharmaceutical and vaccine procurement at UN agencies, granting them favorable conditions. It is expected that WHO will operate similar support measures for WLA-listed countries. WLA listing is determined through a performance evaluation conducted only for regulatory agencies that qualify by receiving a grade of 3 or higher in the Global Benchmarking Tool (GBT) assessment of pharmaceutical and vaccine regulatory systems. The KFDA has systematically prepared for WLA listing, achieving the highest GBT grade (grade 4) in both pharmaceuticals and vaccines as of last November.

WHO highly appreciates the KFDA’s efforts in preparing for and responding to the evaluation within a short period of just over two years. This resilience of the KFDA is the result of the continuous support from staff who have aspired since the establishment of the Food and Drug Safety Headquarters in 1996 to become an agency on par with the U.S. Food and Drug Administration (FDA), as well as experts with international insight who have supported this ambition. WLA listing signifies that the listed country has a world-class transparent and objective pharmaceutical regulatory system. Therefore, WHO expects increased information exchange among WLA-listed agencies and streamlined procedures for pharmaceutical approval and management. Furthermore, WHO anticipates that the KFDA’s WLA listing will significantly enhance South Korea’s accessibility in the international pharmaceutical procurement market.

WHO hopes that pharmaceutical regulatory agencies worldwide will benchmark the Korea Food and Drug Administration in the future. To this end, the KFDA should strive to ensure that domestic and international stakeholders can easily access its specialized information. Additionally, the KFDA should improve its staff’s international communication capabilities. WHO expects the KFDA to continuously develop and share international standards based on rational benefit-risk assessments throughout the entire product lifecycle through relentless regulatory innovation to enhance rapid market access and safety management of domestically developed innovative pharmaceutical products, and to continue supporting the reduction of health disparities between countries.

Jinho Shin, Medical Officer, Essential Medicines and Health Technologies, WHO Western Pacific Regional Office