Through the new collaborating centre, WHO will expand access to structured, competency-based regulatory training and support the development of a stronger workforce capable of regulating medicines and vaccines.
**SOUTH KOREA—**The World Health Organization (WHO) has designated the Global Harmonization Centre (GHC) in the Republic of Korea as a WHO collaborating centre for strengthening health product regulatory systems 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 support countries in developing the skills and expertise needed to regulate medicines and vaccines and ensure access to safe, effective and quality assured health products.
Expanding regulatory capacity
WHO said effective regulatory systems are essential to protect public health and advance universal health coverage.
However, about 70% of its Member States still lack well-functioning regulatory systems, while shortages of skilled regulatory professionals remain a major challenge, particularly in low- and middle-income countries.
Meanwhile, rapid advances in science and technology, increasingly complex global supply chains and growing demands on regulatory authorities have increased the need for continuous workforce development.
Through the new collaborating centre, WHO will expand access to structured, competency-based regulatory training and support the development of a stronger workforce capable of regulating medicines and vaccines.
“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,” he added.
Building on long term cooperation
The GHC operates under MFDS, which WHO recognizes as a WHO Listed Authority.
The designation therefore builds on the Republic of Korea’s established regulatory expertise and international role in promoting regulatory excellence.
WHO and MFDS have collaborated for nearly two decades through regulatory training programmes, support for normative work and initiatives aimed at promoting international regulatory convergence.
The new designation will provide a framework for expanding this cooperation and turning established regulatory expertise into sustained capacity building for countries.
WHO will combine its global mandate, regulatory standards and knowledge of country needs with the training infrastructure and technical expertise of MFDS, NIFDS and the GHC.
The partnership will focus on helping regulatory professionals develop the skills required to respond to advances in science and increasingly complex health products.
The initiative will cover regulatory capacity building for medicines and vaccines, with training designed to help national authorities strengthen their ability to assess and oversee health products and protect public health.
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