WHO Taps South Korea’s Regulatory Expertise on Medicine and Vaccine Safety

The designation comes at a time when many countries still struggle to maintain regulatory systems capable of keeping pace with expanding health needs and rapidly changing technologies.

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, creating a new international platform for sharing regulatory expertise and helping countries build skilled workforces capable of overseeing medicines and vaccines. 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 regulators with structured, competency-based training designed around the increasingly complex realities of modern health products, from scientific innovation and manufacturing to global supply chains and quality assurance.

The designation comes at a time when many countries still struggle to maintain regulatory systems capable of keeping pace with expanding health needs and rapidly changing technologies. WHO estimates that around 70% of its Member States do not yet have well-functioning regulatory systems, leaving significant gaps in the ability to consistently assess the quality, safety and effectiveness of health products. A shortage of trained regulatory professionals adds another layer of pressure, particularly in low- and middle-income countries where authorities may be responsible for increasingly sophisticated products without having enough specialists, training opportunities or technical resources.

Building the Skilled Regulatory Workforce Countries Need

Medicines and vaccines pass through extensive regulatory processes before and after reaching patients, covering areas such as clinical evidence, manufacturing quality, product authorization, safety monitoring and oversight of supply chains. These responsibilities are becoming more demanding as new technologies enter healthcare and products increasingly move through international production and distribution networks, making continuous professional development essential for regulators expected to make decisions that directly affect public health.

The new WHO collaborating centre will expand access to practical regulatory education and help professionals develop competencies that can be applied within their national systems. Training will focus on strengthening the workforce responsible for medicines and vaccines, giving countries another route to build institutional knowledge rather than relying only on short-term technical assistance.

"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. Silo said the centre will allow WHO to draw on the Republic of Korea's regulatory expertise and training experience while directing greater support toward countries where regulatory capacity needs strengthening.

Korea's Regulatory Experience Becomes a Global Training Resource

The GHC operates under MFDS, which is recognized as a WHO-Listed Authority, reflecting the strength and maturity of the Republic of Korea's regulatory system. This experience provides a valuable foundation for training professionals from other countries, especially as regulators face similar challenges involving emerging technologies, increasingly complex products and interconnected supply networks that can quickly turn a national regulatory issue into an international concern.

The designation also marks a new stage in almost two decades of cooperation between WHO and MFDS. Their work has covered regulatory training programmes, contributions to WHO's normative activities and international efforts to bring regulatory approaches closer together. Establishing a collaborating centre gives that relationship a more structured mechanism for turning accumulated knowledge into sustained capacity building that can reach regulatory authorities across different regions.

Stronger Regulation Can Mean Safer Health Products for Millions

The partnership brings together WHO's global standards, international mandate and understanding of regulatory needs with the technical expertise, institutional experience and training infrastructure available through MFDS, NIFDS and the GHC. This combination can help regulators develop practical skills while keeping their knowledge current as scientific advances reshape medicines, vaccines and other health technologies.

For patients, much of this regulatory work remains invisible, yet it influences whether medicines are properly evaluated, vaccines meet quality requirements and safety problems are identified and managed. Building stronger regulatory authorities can increase confidence in the products people receive, reduce weaknesses that allow poor-quality health products to enter supply chains and give health systems a stronger foundation for responding to routine needs and future emergencies.

The GHC's new role gives WHO another way to turn established regulatory knowledge into practical skills across borders, helping countries develop professionals capable of protecting patients while supporting resilient health systems and progress toward universal health coverage.