课题组将从中药知母中提取的甾体皂苷制成欣舒片,取得新药证书,并进行产业化研究。
Our team prepared the timosaponin of Anemarrhena into XingShu tablets, which had been certificated and already started industrial scale researches.
对于仅持有《新药证书》,但未取得药品批准文号的新药技术转让,转让方应当为《新药证书》所有署名单位。
For drugs with new drug certificates but without drug approval numbers, the transferor shall be all the holders of the new drug certificates.
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。
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.
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