Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press Release] MFDS Achieves Highest Maturity Level in Regulatory System by WHO
  • Registration Date 2022-11-30
  • Hit 10014

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.

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).

* National Regulatory System (RS), Registration and Marketing Authorization (MA), Vigilance (VL), Market Surveillance and Control (MC), Licensing Establishments (LI), Regulatory Inspection (RI), Laboratory Testing (LT), Clinical Trials Oversight (CT) NRA Lot Release (LR)

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.

Attached File
  • [22.11.30.(수) 보도자료] MFDS Achieves Highest Maturity Level in Regulatory System by WHO.pdf Download preview
  • [22.11.30.(수) 보도자료] MFDS Achieves Highest Maturity Level in Regulatory System by WHO.hwp Download preview

Division WLA (WHO-Listed Authority) Task Force

Written by Hyun Mi-young

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