Proposed revision of the "Regulation on Safety of Pharmaceuticals, etc." (10 page(s), in Korean)
1) Clarification of submission requirements for registered drug substance to receive marketing authorization for finished product (Article 4, Paragraph 1, subparagraph 7 of the Regulation) MFDS intends to clarify the scope of data on drug substances which have been already registered and don't have to be submitted out of those data on drug substances to be submitted to apply marketing authorization for finished product.
2) Preparation of the basis for delegation for new establishment of specific procedures to import pharmaceuticals including urgent introduction of pharmaceuticals(Article 57, Paragraph 3 of the Regulation) For the medicinal products which have supplied through the urgent introduction procedure because alternative medicinal products are not available, MFDS intends to improve efficiency and transparency of operating system by providing a basis for delegation for establishment of specific procedure.
3) Reinforcement of obligation and compliance for wholesalers to distribute pharmaceuticals, etc. (Appendix 6 of the Regulation)
MFDS intends to improve distribution quality by strengthening obligation and compliance for pharmaceuticals wholesalers ,more specifically, while a person who has already obtained pharmaceuticals marketing authorization, importer and wholesalers shall maintain proper temperature for the pharmaceuticals during storage and transport and shall not install temperature controller on the thermometer, they may add health functional food and cosmetics on the scope of storage list, shall also set specific self inspection interval, aside from qualified distributors, all wholesalers shall receive training from Korea Pharmaceutical Distribution Association, consignors shall manage and supervise consignees.