Regulatory Database
A comprehensive database of drug regulations, guidelines, and standards in China.
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ChinaIn forceType: RegulationRelease Date: 2021-07-04Implementation Date: 2021-07-04
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In forceType: RegulationRelease Date: 2021-06-24Implementation Date: 2021-06-24
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ChinaChanges and Reporting Requirements of Listed Biological Products已上市生物制品变更事项及申报资料要求In forceType: RegulationRelease Date: 2021-06-18Implementation Date: 2021-06-18
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ChinaGood Pharmacovigilance Practice (GVP)药物警戒质量管理规范In forceType: RegulationRelease Date: 2021-05-13Implementation Date: 2021-12-01
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ChinaIn forceType: LawRelease Date: 2021-04-29Implementation Date: 2021-04-29
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ChinaRegulations on Listed Chinese Medicine Changes and Information已上市中药变更事项及申报资料要求In forceType: RegulationRelease Date: 2021-02-24Implementation Date: 2021-02-24
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ChinaIn forceType: GuidelineRelease Date: 2021-02-10Implementation Date: 2021-02-10
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ChinaTechnical Guidelines on Studies of Post-marketing CMC Changes to Chemical Drugs (Trial)已上市化学药品药学变更研究技术指导原则（试行）In forceType: GuidelineRelease Date: 2021-02-10Implementation Date: 2021-02-10
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ChinaTechnical Guidelines on Clinical Changes for Marketed Chemical Drugs and Biological Products已上市化学药品和生物制品临床变更技术指导原则In forceType: GuidelineRelease Date: 2021-02-10Implementation Date: 2021-02-10
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ChinaIn forceType: RegulationRelease Date: 2021-02-10Implementation Date: 2021-02-10
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)