MFDS designated the world’s first WHO Collaborating Centre for regulatory capacity building

The Global Regulatory Harmonization Center (GHC) under the Ministry of Food and Drug Safety (MFDS) has been designated as the World Health Organization’s (WHO) first Collaborating Centre for capacity building and training in medical product regulatory systems.

MFDS said on the 2nd that the GHC, under the National Institute of Food and Drug Safety Evaluation, had been designated as a WHO Collaborating Centre. WHO officially announced the designation in a newsletter on the 27th of last month (local time).

The designation follows the listing of all MFDS functions in the medicines and vaccines sectors on WHO’s Listed Authorities (WLA) list. It was achieved less than 8 months after MFDS submitted a concept note for the center’s designation at the end of December last year.

The GHC will operate under the official name “WHO Collaborating Centre for Capacity Building and Training in Medical Product Regulatory Systems (CC No. KOR-116)” from July 30, 2026, through July 29, 2030.

In line with WHO priorities, the GHC will provide training to regulatory officials from member states and participate in developing training programs and methods to strengthen regulatory capacity for medicines and vaccines. In November, it plans to invite officials from WHO headquarters and the Western Pacific Regional Office to an international workshop, launching its official activities.

WHO said, “The new Collaborating Centre, GHC, will draw on the Republic of Korea’s extensive regulatory expertise and training experience to expand support to countries around the world and strengthen regulatory capacity where it is most needed.”

Yu Kyung Oh, commissioner of MFDS, said, “This designation is significant because it reaffirms MFDS’ regulatory capacity and represents WHO’s recognition that the GHC has played a major role in strengthening regulatory systems globally. We will work closely with WHO to play a pivotal role in narrowing regulatory differences between countries.”

MFDS plans to continue supporting improvements in the export competitiveness and overseas expansion of domestic industry, based on the increased confidence in Korea’s domestic regulatory system and medical products and the strengthened international standing resulting from the designation.