The MFDS announced on the 11th that it will partially revise the Regulation on Drug Product Authorization, Declaration, & Review to secure the quality reliability of generics in accordance with international standards.

The revision includes improving the management of manufacturing methods such as Rx drugs manufacturing processes, deleting some submission data exemption regulations upon approval based on foreign drugs, process documents, and specifications, establishing standards for packaging disposable eye drops, and listing active ingredients in the product name.

Accordingly, from November 12 next year, when licensing Rx drugs, it will be improved to describe in detail according to CTD