Republic of Korea - Proposed amendments to the "Regulation on Good Manufacturing Practice for Medicinal Products"

Ministry of Food and Drug Safety has issued notification proposing amendments to the "Regulation on Good Manufacturing Practice for Medicinal Products".

Detailed guidelines and principles of good manufacturing practice for medicinal product are defined and mandated. Annex 17 to this Regulation is equivalent to the PIC/S GMP Guide Part IStipulate PIC/S GMP Guide Part I as annex 17 to this Regulation.

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.