□ The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) announced on November 30 that it has reached Maturity Level 4, the highest level achievable for regulatory system evaluation against the WHO’s Global Benchmarking Tool (GBT), in both medicines and vaccines regulations.

ㅇ WHO utilizes GBT — an evaluation tool that checks 9 regulatory functions* against a total of 268 sub-indicators — to objectively assess the maturity of the regulatory system of a National Regulatory Authority (NRA) on a scale from 1 (the lowest) to 4 (the highest).

* ① National Regulatory System (RS), ② Registration and Marketing Authorization (MA), ③ Vigilance (VL), ④ Market Surveillance and Control (MC), ⑤ Licensing Establishments (LI), ⑥ Regulatory Inspection (RI), ⑦ Laboratory Testing (LT), ⑧ Clinical Trials Oversight (CT) ⑨ NRA Lot Release (LR)

ㅇ The Republic of Korea is the first* country, benchmarked by WHO to reach Maturity Level 4 for both medicines and vaccines among regulatory authorities around the world.

* Singapore reached Maturity Level 4 in medicines in February 2022.

** Four regulatory systems subject to WHO evaluation: medicines, vaccines, blood products and medical devices. Currently, WLA (WHO-Listed Authority) designation is applied only to medicines and vaccines.