KR South Korea
  • 71 - Chemical technology


Regulation on Safety of Pharmaceuticals, etc. (95 page(s), in Korean)

Article 4: Reinforcement on product license application requirements for pharmaceuticals

MFDS intends to expand objectives to submit standard, test method data and bioequivalence test data into prescription drug, where pharmaceutical manufacturer applies for product approval.

MFDS intends to reinforce the safety management system by requesting them to submit the materials, without exception, where a person who intends to apply for approval of pharmaceuticals marketing has been already granted approval for products which are same ingredient name and specification with the product for the application, where the person asks contract manufacturer to produce the pharmaceuticals under the same process as the said manufacturer, it was possible for the applicant to apply for the approval without submission of evaluation materials.

Article 4, 48: Expansion of targets for Good Manufacturing Practice application

MFDS intends to improve the regulation by applying pharmaceuticals not directly applied to human such as disinfectant, which was excluded from it before, to comply with Good manufacturing Practice.(provided that the pharmaceuticals such as high pressure medical gas, which was notified by the prime minister of Ministry of Food and Drug Safety, shall be excluded).

Article 48, 48(2): Recommendation of compliance with quasi-drug GMP and issuance of certificate of determination of conformance

MFDS intends to create legal ground to recommend manufacturer to comply with manufacturing of quasi-drug and GMP and issue certificate of determination of conformance for the manufacturer which complies with the quasi-drug GMP.

Article 62(4): Expansion of target for disclosing information on notified pharmaceuticals (Article 62 (4)) MFDS intends to provide more efficient information on the notified pharmaceuticals by adding the name of registered pharmaceuticals, which are references of safety and efficacy for the information on the website.