KR Südkorea
  • 11 - Medizintechnik


A partial amendment to Regulation for Pharmaceutical Approvals, Notifications and Reviews (15 page(s), in Korean)

The Ministry of Food and Drug Safety (MFDS-) of the Republic of Korea is issuing the proposed amendments to the MFDS Notice "Regulation for Pharmaceutical Approvals, Notifications and Reviews" as follows:

-           The scope of pharmaceuticals that are required to submit Common Technical Document (CTD) for review under Article 6 would be expanded to include preparations for which specialty dosage forms are authorized (such as extended release products) and the drugs requiring safety and efficacy assessment such as injections, ophthalmic solutions and otic solutions whose excipients are different from those of the previously approved drug. 

-           When drugs are outsourced for manufacturing in the manufacturing sites drugs manufactured from which have gone through bio equivalence (BE) test, they are newly required under Article 28 to submit BE test data for review.