FAQ
Drugs

What documents should be submitted for the registration of a generic drug?

刊登日期:2023-09-17  |  點閱次數 : 2672 次 

According to "Regulations for Registration of Medicinal Products" article 3, Please attached "Refuse to File RTF" check list (https://www.fda.gov.tw/TC/siteListContent.aspx?sid=3037&id=41522), and refer to the Appendix 4 in the "Regulations for Registration of Medicinal Products”.

(https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030057). Relevant document should be submitted to Taiwan Food and Drug Administration, Ministry of Health and Welfare.

 

 

 

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