Regulatory Database
A comprehensive database of drug regulations, guidelines, and standards in China.
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ChinaProcedures for Priority Review and Approval of Drug Marketing Authorization (Trial)药品上市许可优先审评审批工作程序(试行)In forceType: RegulationRelease Date: 2020-07-08Implementation Date: 2020-07-08
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ChinaWork Procedures for the Review of Breakthrough Therapies (Trial)突破性治疗药物审评工作程序(试行)In forceType: RegulationRelease Date: 2020-07-08Implementation Date: 2020-07-08
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ChinaWork Procedures for the Review of Drugs for Conditional Approval (Trial)药品附条件批准上市申请审评审批工作程序(试行)In forceType: RegulationRelease Date: 2020-07-08Implementation Date: 2020-07-08
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ChinaWork Procedures for the Priorty Review of Drugs for Marketing Authorization (Trial)药品上市许可优先审评审批工作程序(试行)In forceType: RegulationRelease Date: 2020-07-08Implementation Date: 2020-07-08
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ChinaAnnouncement on Implementing the 2020 Edition of the Pharmacopoeia of the People's Republic of China国家药监局关于实施2020年版《中华人民共和国药典》有关事宜的公告(2020年 第80号)In forceType: NoticeRelease Date: 2020-07-03Implementation Date: 2020-12-30
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ChinaIn forceType: GuidelineRelease Date: 2020-07-03Implementation Date: 2020-07-03
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ChinaIn forceType: GuidelineRelease Date: 2020-07-02Implementation Date: 2020-12-30
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ChinaChinese Pharmacopoeia 9011 Guidelines for In Vivo Bioavailability and Bioequivalence Studies on Drug Preparations9011 药物制剂人体生物利用度和生物等效性试验指导原则In forceType: GuidelineRelease Date: 2020-07-02Implementation Date: 2020-12-30
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ChinaIn forceType: GuidelineRelease Date: 2020-07-02Implementation Date: 2020-12-30
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ChinaIn forceType: GuidelineRelease Date: 2020-07-02Implementation Date: 2020-12-30
Most Popular
- Chinese Pharmacopoeia 2020 Edition
- Chinese Pharmacopoeia 9012 Guidelines for Validation of Quantitative Analytical Method of Biological Samples
- Drug Administration Law of the People's Republic of China (2nd Revision)
- Chinese Pharmacopoeia 9001 Guidelines for the Stability Testing of Drug Substances and Preparations
- Provisions for Post-approval Changes of Drugs (Interim)