South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics

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:

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.

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

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.

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