Taiwan FDA Issues eCTD Specifications and Validation Criterion

In order to promote Taiwan’s adoption of ICH Electronic Common Technical Document (eCTD) format of , applicants will be able to use the registration platform (ExPress)  to submit eCTD documents, Taiwan FDA has formulated the following guidelines in November/December 2020:

– eCTD Guidelines containing eCTD specifications, recommendations and principles for the submission of documents for new drug, biological drug, and generic drug registration and post-market changes.Other than describing Modules 2 to 5 in accordance with  ICH eCTD Specification V3.2.2, this guideline also defines Module 1 information that complies with Taiwan’s regulatory framework, providing applicants on how to establish submission data, life cycle management and other necessary transmission information.  Based on this guideline, the applicant can perform these activities for required documents: publishing, validation and submission, and TFDA will perform validation and review after receiving the submission.

– eCTD Validation Criterion,  to validate that the submitted documents are according to eCTD guidelines. This guidelines is for industry to use standardized eCTD format to prepare documents and submission for drug registration, complying with the relevant specifications of ICH eCTD Specification V3.2.2. For all eCTD submission documents, they must be validated in accordance with these guidelines before they can be completed on the Taiwan FDA’s drug registration platform (ExPress).

藥品查驗登記電子通用技術文件指引 (eCTD文件指引)中華民國109年12月31日 https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2984&id=35652
藥品查驗登記電子通用技術文件驗證指引 , 中華民國109 年11 月

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