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The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually receive reference applications — applications to put a drug on the local market that has already been approved elsewhere. As a...

The technical documentation involves primary documentation which supports an NDA or ANDA in the form of a DMF/ CTD. It compiles the Chemistry, Manufacturing and Controls (CMC) information for the drug substance, as per instructions mentioned in guidance documents from the US Food and Drug Administration (FDA) or the International Conference on Harmonization (ICH). The electronic version of full DMF is submitted to the international...