The Taiwanese Food and Drug Administration (TFDA) announced that its registration and market approval documentation requirements will align with the Common Technical Document (CTD) format for e-submission.
Use of the CTD format should reduce costs, labor, and time required for new drug applications inside and outside Taiwan. The TFDA anticipates that e-submission of documents will speed the approval process by granting much faster access to reviewers. The CTD format and its electronic counterpart were developed by the International Conference on Harmonization (ICH). Like the US, Europe, and Japan, Taiwan uses a slightly modified version of the CTD format for its own documents.