South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official Communication Channel , Drug Approvals and other topics:
- 2020 MFDS Guide on GMP improvements for Medicinal Products
2020년도 의약품 GMP 개선사항 안내서 https://www.mfds.go.kr/brd/m_522/view.do?seq=33266
This guide contains guidance on major improvements in the drug GMP system implemented in 2020, including the revisions to the Drug Safety Rules and the Good Manufacturing Practice (GMP) Regulations for Medicinal Products, and related questions and answers (Q&As) relating to the revisions.
- 2020 MFDS FAQ on Medicinal Products/ Quasi-Drugs/Cosmetics
2020년도 자주하는 질문집 – 의약품·의약외품·화장품 https://www.mfds.go.kr/brd/m_218/view.do?seq=33351
This 160-page FAQ with 9 sections have been produced so that public, businesses and government officials can use it as a reference. It contains answers to the questions relating to drug product approval, manufacturing and quality controls, drug clinical trials, advertising and labelling, herbal medicines, biological products, narcotics, quasi-drugs, cosmetics and their applicable regulations.
- MFDS Q&A and User Manual on ‘Official Communication Channel’ for Review and Approval of Medicinal Products
- 의료제품 허가·심사「공식 소통채널」질의응답(Q&A) 및 사용자 매뉴얼 https://www.mfds.go.kr/brd/m_227/view.do?seq=33287
These MFDS questions and answers (Q&As) detail the Official Communication Channel procedures between applicants and the MFDS at key milestones of the in approval processes, which may facilitate earlier availability of safe and effective medical products in South Korea. In addition, this document has screenshots showing applicants how to request the such meetings at the MFDS website.