When should the reference drug be used for the identification of traditional Chinese materia medica?

在中成药及中药材的薄层色谱鉴别中何时采用对照药材法？

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Article 22 In case clinical trials are necessary deemed by CDE, the reference drug shall be the marketed products manufactured by the transferor.

第二十二条经审评需要进行临床试验的，其对照药品应当为转让方药品生产企业原有生产的、已上市销售的产品。

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In case the transferor did not obtain a drug approval number, the reference drug shall be selected in accordance with the drug Registration Regulation and relevant technical guidelines.

转让方仅获得《新药证书》的，对照药品的选择应当按照《药品注册管理办法》的规定及有关技术指导原则执行。

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You must contact the sponsor of the reference listed drug for your ANDA, Reckitt Benckiser Pharmaceuticals Inc.

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