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What documents should be submitted for the registration of a drug substance (API)?

刊登日期：2020-07-21  |  點閱次數 : 1041 次 

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. 1021400246 entitled “API Registration Technical Dossier Checklist” issued on February 21, 2013.

 

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