The regulatory authorities are leveraging the Pharmaceutical Inspection Co-operation Scheme (PIC/S) re-certification to build a pharmaceutical trust network with key Asian countries, including Japan, Singapore, and Taiwan. Discussions are also underway to exempt inspections for pharmaceutical imports and exports among these nations.

Jung-yeon Kim, head of the Pharmaceutical Quality Division at the Ministry of Food and Drug Safety (MFDS), stated during a press briefing on November 26th, “With the PIC/S re-certification, trust in Korea’s GMP documentation has significantly improved. This has led to an increasing number of instances where manufacturing site inspections for pharmaceutical exports are replaced with document reviews.”

Kim highlighted that this year marks the 10th anniversary of Korea’s PIC/S membership. “We successfully passed the periodic re-evaluation, meeting all criteria with high standards, further solidifying Korea’s standing as a PIC/S member internationally. Foreign authorities have also acknowledged Korea’s enhanced GMP standards following this evaluation,” he added.

Kim emphasized the growing trust in the MFDS, noting, “Foreign authorities increasingly request Korea’s inspection reports instead of conducting separate inspections during pharmaceutical export processes. This trust is expected to positively impact Korea’s pharmaceutical exports.”

Japan, with its strong ties to Korea’s pharmaceutical industry, has drawn attention by actively seeking discussions on inspection exemptions. The MFDS also revealed plans to explore a broader pharmaceutical trust framework with PIC/S member countries in Asia, including Singapore and Taiwan.

Kim remarked, “Several countries have expressed interest in discussing inspection exemptions, with Japan showing the most active engagement. Japan has proposed forming a core group in the Asian region alongside Korea, Singapore, and Taiwan to enhance pharmaceutical collaboration and increase exchanges.”

The MFDS aims to leverage the PIC/S re-evaluation to help Korean pharmaceutical companies overcome regulatory barriers abroad. Kim acknowledged existing challenges, especially in non-MRA (Mutual Recognition Agreement) countries, but emphasized that enhanced trust in Korea’s regulatory framework provides opportunities for document-based reviews.

He concluded, “The MFDS will continue efforts to minimize regulatory barriers and support the global expansion of Korea’s pharmaceutical industry. We also aim to maintain Korea’s inclusion in the WLA (WHO Listed Authority) and the EU White List.”