Korea Drug GMP Requirements and Audits

korea medical market, korea mfds

Korea is currently the 10th largest drug market in the world. While in the past, Korean drug companies mostly made generic drugs, today, they are making new chemical and biological products. Korean drug companies and foreign drug companies looking to sell their finished or API products in Korea must meet Korean GMP standards.

The Korean MFDS (FDA) regulates all drugs and GMP requirements. The first GMP regulations for drug GMP in Korea were in 1994. Since then, in 2002, the Mandatory Implementation of GMP for Active Pharmaceutical Ingredients (APIs) was issued. In 2008, a regulation was issued for the — Introduction of pre-approval GMP inspection for medicinal products, and new regulations for validation, qualification, and product quality review were also promulgated. In 2014-2015, an Ordinance was issued for harmonization with the PIC/S GMP guides, and a system for renewing a GMP certificate was issued too.

The Korean MFDS does both a pre-approval GMP assessment and a post-approval GMP assessment every 3 years or so. Sometimes, if the site has already met Korean GMP requirements, future audits can be done on paper, whereas for some products or manufacturing methods, the audit will be done in person. During the audit, MFDS officials will want to review drawings of the manufacturing site, see documents on the working areas of the factory, quality control, batch production records, validation data, etc. In 2016, Korea became a member of ICH.

In late 2020, the Korean MFDS announced 3 new Q&As with respect to Korean GMP. The first document issued was called – the 2020 MFDS Guide on GMP Improvements for Medicinal Products. The second document was called – 2020 MFDS FAQ on Medicinal Products/Quasi-Drugs/Cosmetics. Finally, the document – MFDS Q&A and User Manual on “Official Communication Channel” for Review and Approval of Medicinal Products was issued.

Please click here to read an unofficial translation of the most recent Korean GMP regulations. If you are interested in a Korean drug GMP audit, please contact us.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://www.mfds.go.kr/eng/index.do