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

这是中央存放报告可疑不良反应相关的药品批准在欧洲经济区和药物正在研究在临床试验。

These are the central repositories for reports of suspected adverse reactions related to medicines authorised in the European Economic Area and medicines being studied in clinical trials.

youdao