The Ministry of Food and Drug Safety (MFDS) will hold an annual Pharmaceutical Inspection Co-operation Scheme (PIC/S) seminar online from Tuesday to Thursday.
It is the largest annual event in the good manufacturing practice (GMP) area. According to the ministry, experts from major regulatory agencies, PIC/S members, interested countries, and the World Health Organization (WHO) gather to discuss improving the quality control of medical products.
About 320 GMP inspectors and regulators from 68 organizations in 48 countries will participate and discuss the GMP evaluation approaches in the post-Covid-19 era. PIC/S is an international organization to harmonize GMP standards and improve the quality of inspection of pharmaceutical products. It has 54 regulatory agencies and 50 countries, including Korea, the U.S., and Japan, as members.
On Tuesday, the food and drug safety ministry will host a session to share information on the status and experience of remote evaluation techniques and GMP inspection results based on mutual trust. The ministry will also share the current cooperation between Korea and the Association of Southeast Asian Nations (ASEAN) with drug regulatory authorities worldwide and prepare opportunities to build a network with inspectors from PIC/S member countries.
Korea joined PIC/S in 2014 when the ministry met GMP standards comparable to that of PIC/S. Regulator introduced a new system to issue GMP certification in the same year to improve the nation’s GMP management quality.
Swissmedic, a Swiss Agency for Therapeutic Products, and the Korean ministry agreed in 2019 to rely on each other’s GMP inspection results for medicinal products, allowing Korean pharmaceutical companies to present Korean regulator’s inspection results when in need of Switzerland’s review.
European Union (EU) authorities also gave a whitelist status to Korea, exempting it from submitting written confirmation that medicines shipped to Europe meet the local GMP standards.
“The PIC/S annual seminar is not held in automatic rotation by member countries. We believe holding the meeting this year reflects the global recognition of our capabilities in GMP inspection,” said an official at the ministry’s Pharmaceutical Safety Bureau. “The seminar will be a forum to exchange and discuss GMP measures implemented in each country amid the Covid-19 pandemic, which will further strengthen the expertise of Korea’s GMP inspectors.”
The official added that the ministry would continue to cooperate with foreign regulatory agencies to improve its capability and actively lead the international harmonization of pharmaceutical GMP.