South Korea's Ministry of Food and Drug Safety met with Thai regulators alongside 10 domestic pharmaceutical companies to relay the difficulties they face in winning drug approvals and registrations in the country. The ministry discussed reliance-based regulatory frameworks and procedures for recognizing reference agencies with the Thai Food and Drug Administration, while the companies held talks with local firms and buyers on exports, distribution and technology cooperation.
The ministry said on the 16th that it hosted a Korea-Thailand pharmaceutical forum in Bangkok on the 14th together with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the Korea Trade-Investment Promotion Agency (KOTRA). A total of 28 people took part, including officials from the ministry and the association and representatives of 10 Korean drugmakers seeking to enter the Thai market, as part of the ministry's public-private delegation program for pharmaceutical market entry.
Thailand is the third-largest pharmaceutical market in Southeast Asia and a country where Korean drugmakers see strong demand for market entry. The ministry began the program in Vietnam in 2023 and sent public-private delegations to Indonesia in 2024 and again this year, and to Japan last year. Thailand was chosen as this year's target country.
About 120 officials from regulatory agencies, governments and the pharmaceutical industry in both countries attended the forum. Participants shared information on drug approval systems, trends in the pharmaceutical and biotech industries, and opportunities for investment and research cooperation. Korean companies discussed their experience in the Thai market and the latest industry technology trends with local health authorities and industry officials.
The two sides also discussed ways to reduce the regulatory burden of the local approval process. Ministry officials met with senior officials from Thailand's Ministry of Public Health and its Food and Drug Administration to share information on drug review systems and regulatory issues. In particular, the ministry requested an exchange of information on reliance frameworks, under which regulators use review results and data from other countries to reduce duplicate assessments, and on the requirements and procedures for recognizing foreign regulators as reference agencies. Drawing on its experience of being listed among the World Health Organization's WHO-Listed Authorities (WLA), the ministry also proposed cooperation on strengthening the capabilities of regulatory specialists.
The ministry also directly conveyed the difficulties Korean companies face in the Thai drug approval and registration process. After gathering the companies' regulatory concerns through a preliminary meeting, the ministry asked the Thai Food and Drug Administration to provide information on detailed approval procedures and requirements and to communicate more smoothly with companies.
On the 15th, Korean companies held one-on-one business meetings with local Thai firms and buyers, linked to a Korea-Thailand bio-health partnership event organized by KOTRA. The meetings were aimed at identifying concrete business opportunities in exports and distribution as well as technology cooperation.
"We plan to continue expanding cooperation channels with regulatory authorities in major countries and to take up the regulatory difficulties that Korean pharmaceutical and biotech companies face in overseas markets as agenda items for cooperation between regulators, supporting their market entry," the ministry said.
