The Ministry of Food and Drug Safety has joined a joint evaluation team to gauge the suitability of a foreign regulatory body for membership in the Pharmaceutical Inspection Co-operation Scheme, a first for the ministry since it joined the international organization in 2014. (Yonhap News)

By Jeong Euiseok

For the first time since joining the Switzerland-based organization Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014, the Ministry of Food and Drug Safety is taking part in a joint assessment team for evaluating the suitability of another country's regulatory authority for PIC/S membership.

The ministry on Nov. 12 said its participation is the first of its kind since Korea entered the PIC/S.

With 53 member countries, PIC/S leads the global standardization of good manufacturing practices (GMP) and related inspections.

The team's focus is on China’s National Medical Products Administration and its key local government authorities. Korea is part of an on-site assessment team spanning the regulators of 12 other nations like the U.S. Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.

Kim Jung Yeon, director of the ministry's Pharmaceutical Quality Division and a GMP expert, from Nov. 17-19 will visit a pharmaceutical plant in China's Jiangsu Province in coordination with Beijing. She plans to conduct an evaluation of the adequacy of China's pharmaceutical GMP system and management of its GMP inspectors.

The ministry said its participation in this team is a testament to global recognition of Korea's standards in pharmaceutical quality control and regulatory capabilities, adding that it hopes this raises the country's international standing within the PIC/S framework.

innocence@korea.kr