Republic Of Korea - Proposed amendments to the Regulation on Safety of Pharmaceuticals, etc.

Ministry of Food and Drug Safety has issued notification on proposed amendments to the Regulation on Safety of Pharmaceuticals, etc. Amendments include Good Manufacturing Practices and quality control standards reflecting properties of blood components were newly established.

A legal basis provision is newly established for indicating country of origin of raw material (herbal substances) of herbal medicinal product.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.