负责审核和确认产品说明书，在规定时限内提交临床试验和新药注册申请；
Verify product description; Submit data of clinical trials and new drug registry application.
第二十五条申请新药注册，应当进行临床试验或者生物等效性试验。
Article 25 for the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.
第二十五条申请新药注册，应当进行临床试验或者生物等效性试验。
Article 25 for the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.
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