Shall batch analyses enclosed in the submitted dossier of imported drugs be performed domestically?

刊登日期：2019-11-13 | 點閱次數 : 1240 次

No. Manufacturers of imported drugs do not need to perform batch analyses domestically. Please refer to Article 9 & 10 of Regulations for Registration of Medicinal Products for the regulations of certificate of analysis.

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Shall batch analyses enclosed in the submitted dossier of imported drugs be performed domestically?

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