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药物临床试验数据监查委员会指导原则(试行)
《药品注册核查检验启动工作程序(试行)》
《药品注册生产现场核查和上市前药品生产质量管理规范检查衔接工作程序(试行)》
《药品注册核查要点与判定原则(药学研制和生产现场)(试行)》
《药品注册核查要点与判定原则(药物临床试验)(试行)》
《药品注册核查要点与判定原则(药理毒理学研究)(试行)》
《药品注册核查工作程序(试行)》
Overview of Clinical Study & GCP
药物临床试验必备文件保存指导原则
药物警戒质量管理规范
EMA Good pharmacovigilance practices
中华人民共和国人类遗传资源管理条例
药品注册管理办法
中华人民共和国疫苗管理法
中华人民共和国药品管理法
21CFR-11
药物临床试验质量管理规范
ICH-GCP (ICH E6)
药物警戒检查指导原则(2022年4月15日施行)