Medicinal Products, Pharmaceuticals

Proposed partial amendments to the "Regulation on the Registration of Drug Substance; (11 page(s), in Korean)

The proposed amendments to the "Regulation on the Registration of Drug Substance" are as follows:

A. to clarify the expert in the medicine and pharmacy who reviewed translated documents for registration of drug substance and allow English translation of submitted documents written in other foreign languages. (Article 3 of the draft)

B. to simplify the requirement for registration of drug substance by replacing Good Manufacturing Practice (GMP) inspection with submission of a GMP certificate and modify the relevant provisions (Article 4 and 5 of the draft and Annex 2)