Please refer to the Appendix 8 and 9 of the “Regulations for Registration of Medicinal Products”. Applications submitted for an API Registration are expected to be complete based on the requirements listed in the announcement no. 1101407579 entitled “API Registration Technical Dossier Checklist” issued on August 10, 2021.

https://www.fda.gov.tw/TC/siteListContent.aspx?sid=3001&id=37420

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