The World Health Organization (WHO) has designated the Global Harmonization Centre (GHC) in the Republic of Korea as a WHO collaborating centre for health products regulatory system strengthening and training.
Hosted by the National Institute of Food and Drug Safety Evaluation (NIFDS) under the Ministry of Food and Drug Safety (MFDS), the centre will help expand global regulatory capacity by supporting countries in building the expertise needed to ensure access to safe, effective and quality-assured health products.
Effective regulatory systems are fundamental to protecting public health and advancing universal health coverage, yet around 70% of WHO Member States still lack well-functioning regulatory systems. Shortages of skilled regulatory professionals remain a critical challenge, particularly in low- and middle-income countries.
At the same time, rapid scientific and technological innovation, increasingly globalized supply chains and growing demands on regulatory authorities are making continuous workforce development more important than ever.
The new collaborating centre will help WHO address these challenges by expanding access to structured, competency-based regulatory training and strengthening the regulatory workforce for medicines and vaccines across countries.
“Strong regulatory systems ultimately translate into greater confidence that the medicines and vaccines reaching people are safe, effective and quality-assured,” said Hiiti Silo, WHO Unit Head, Regulation and Safety, Regulation and Prequalification Department. “This new collaborating centre will allow us to build on the Republic of Korea’s considerable regulatory expertise and training experience to expand support to countries and strengthen regulatory capacity where it is most needed.”
The GHC operates under MFDS, a WHO-Listed Authority, reflecting the Republic of Korea’s internationally recognized regulatory system and its leadership in regulatory excellence.
The designation of the new collaborating centre builds on nearly two decades of collaboration between WHO and MFDS, spanning regulatory training programmes, support to normative work and international regulatory convergence initiatives.
This long-standing partnership now enters a new phase, providing a mechanism to translate established regulatory expertise into sustained capacity building for countries.
By combining WHO’s global mandate, standards and understanding of country needs with the expertise and training infrastructure of MFDS/NIFDS and the GHC, the partnership will help more regulatory professionals develop the skills needed to keep pace with evolving science and increasingly complex health products.
Ultimately, stronger regulatory capacity means stronger protection for people – helping countries ensure that the medicines and vaccines reaching their populations are quality-assured, safe and effective, while supporting more resilient health systems and progress towards universal health coverage.
