eCTD submission Regulatory

Taiwan Released Guidelines for Adaptation of eCTD Format

Taiwan Food and Drug Administration (TFDA) released guidelines for eCTD specification. Following countries such as the USA, EU, Japan, Australia, Canada and Switzerland, Taiwan will soon adopt the eCTD standard.
The TFDA pre-announced the eCTD validation criteria on 16th June 2020 and will follow up this with a formal announcement after they have received feedback from the stakeholders within the Taiwanese medical industry. The TFDA has made Announcement for “Guidelines for Electronic General Technical Documents for Drug Inspection and Registration” on 31st December 2020. Also provided M1 specification with tw-envelope.mod, tw-leaf.mod and tw-regional.dtd. For more detail, please refer below link: https://www.fda.gov.tw/TC/siteListContent.aspx?sid=2984&id=35652

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