(1) For an API mix which is not yet included in the pharmacopoeial monographs of the top ten medically advanced nations, scientific rationale for mixing the API with the excipient should be provided. For API mixes which are included in the pharmacopoeial monographs of the top ten medically advanced nations, no additional justification is required.

(2) With regards to the common technical documents (CTD) for the API mix, in addition to the API mixing process, complete technical documents must be provided for the API or copy of the DMF approval letter or DMF no. may be provided instead.

(中文版)