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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第三十二条临床研究用药物，应当在符合《药品生产质量管理规范》条件的车间制备。

Article 32 Drugs for use in clinical study shall be prepared in workshops meeting the conditions provided for in the Criterions for the Quality Control of Drug Manufacturing.

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结果通过对药库科学化、规范化的管理，使药品的质量安全得到了保障，确保临床用药安全有效。

Results drug Storehouse through scientific and standardized management, so that quality and safety of drugs are guaranteed to ensure the safe and effective clinical treatment.

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