Regulatory Database
A comprehensive database of drug regulations, guidelines, and standards in China.
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ChinaGuidelines on Communication About Drug Registration Application Supported by Real-world Evidence真实世界证据支持药物注册申请的沟通交流指导原则(试行)In forceType: GuidelineRelease Date: 2023-02-16Implementation Date: 2023-02-16
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ChinaTechnical Guidelines for CMC Study on Generic Chemical Ophthalmic Solution化学药品仿制药溶液型滴眼剂药学研究技术指导原则In forceType: GuidelineRelease Date: 2023-02-16Implementation Date: 2023-02-16
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ChinaIn forceType: GuidelineRelease Date: 2023-02-15Implementation Date: 2023-02-15
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ChinaTechnical Guidelines for Quality Attribute Researches on Chewable Tablets (Chemical Drugs) (Trial)咀嚼片(化学药品)质量属性研究技术指导原则(试行)In forceType: GuidelineRelease Date: 2023-02-14Implementation Date: 2023-02-14
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ChinaICH Guideline M13A: Bioequivalence for Immediate-release Solid Oral Dosage FormsM13A:口服固体速释制剂的生物等效性DraftType: GuidelineRelease Date: 2023-02-14Implementation Date: /
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ChinaIn forceType: GuidelineRelease Date: 2023-02-13Implementation Date: 2023-02-13
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ChinaIn forceType: GuidelineRelease Date: 2023-02-13Implementation Date: 2023-02-13
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ChinaTechnical Guidelines on CMC Study and Evaluation of Oncolytic Virus Products (Trial)溶瘤病毒产品药学研究与评价技术指导原则(试行)In forceType: GuidelineRelease Date: 2023-02-13Implementation Date: 2023-02-13
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ChinaIn forceType: RegulationRelease Date: 2023-02-10Implementation Date: 2023-07-01
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ChinaNotice of NMPA and NHC on Accelerating the Construction of Botulinum Toxin Type A for Injection Traceability System国家药监局综合司 国家卫生健康委办公厅关于加快推进注射用A型肉毒毒素追溯体系建设工作的通知In forceType: NoticeRelease Date: 2023-01-19Implementation Date: 2023-01-19
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)
- Provisions for Post-approval Changes of Drugs (Interim)
- Chinese Pharmacopoeia 9001 Guidelines for the Stability Testing of Drug Substances and Preparations