Global Regulatory Harmonization Center of the Ministry of Food and Drug Safety Designated as WHO Collaborating Centre: "Strengthening Regulatory Capabilities for Medical Products"

[Financial News] The Global Regulatory Harmonization Center (GHC) under the National Institute of Food and Drug Safety Evaluation of the Ministry of Food and Drug Safety has been designated as a World Health Organization (WHO) Collaborating Centre. This is the first time in the world that a WHO Collaborating Centre has been designated in the field of capacity building and training for medical product regulatory systems.
The Ministry of Food and Drug Safety announced on the 2nd that the Global Regulatory Harmonization Center had been designated by the WHO as a 'WHO Collaborating Centre for Capacity Building and Training in Medical Product Regulatory Systems.'
A WHO Collaborating Centre is a system through which the WHO selects and operates specialized institutions in various fields to carry out international health programs.
The designation was influenced by the Ministry of Food and Drug Safety's listing in the WHO Listed Authorities (WLA) for all functions in the pharmaceutical and vaccine sectors, as well as its experience accumulated in the field of international regulation. The achievements of the GHC, which was launched in January last year, in strengthening regulatory capabilities in the medical product sector and contributing to international regulatory harmonization were also recognized.
The GHC will operate under the official name 'WHO Collaborating Centre for Capacity Building and Training in Regulatory Systems for Medical Products.' The designation period runs from July 30, 2026, to July 29, 2030.
The GHC will provide training for regulatory officials from WHO member states and support efforts to strengthen regulatory capabilities. It will also participate in developing training programs and methods to enhance regulatory capabilities for medicines and vaccines.
The GHC plans to invite officials from WHO headquarters and the WHO Regional Office for the Western Pacific to an international workshop this November to discuss areas of cooperation with the WHO.
Regarding the designation, the WHO said, "Building on the Republic of Korea's extensive regulatory expertise and training experience, the centre will help expand support to countries around the world and contribute to strengthening regulatory capabilities."
"The designation as a WHO Collaborating Centre is highly significant because it recognizes the Ministry of Food and Drug Safety's regulatory capabilities and the GHC's activities to strengthen global regulatory system capabilities," said Oh Yu-kyung, Minister of Food and Drug Safety. "We will work with the WHO to narrow regulatory differences between countries and play a pivotal role in regulatory harmonization."
The Ministry of Food and Drug Safety plans to use the designation as an opportunity to enhance international confidence in Korea's medical product regulatory system and help strengthen the export competitiveness of domestic pharmaceutical and biotechnology companies and support their expansion overseas.

[email protected] Jeong Sang-hee Reporter