药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。

Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.

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药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。

Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.

youdao