2024-10-25

真实世界数据支持药品安全性主动监测的一般原则（征求意见稿）_2024_CDR

2024-10-25

药物浓度-QTc临床研究技术指导原则（征求意见稿）_2024_CDE

2024-10-25

抗体偶联药物临床药理学研究技术指导原则（征求意见稿）_2024_CDE

2024-10-24

口服药物胃pH依赖性药物相互作用评价技术指导原则（征求意见稿）_2024_CDE

2024-10-24

关于对创新药以及经沟通交流确认可纳入优先审评审批程序和附条件批准程序的品种开展受理靠前服务的通知_2024_CDE

2024-10-24

中药复方制剂新药研发人用经验信息收集整理技术指导原则（征求意见稿）_2024_CDE

2024-10-23

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2024-10-22

氟[18F]化钠注射液仿制药药学研究技术要求（试行）_2024_CDE

2024-10-22

《生物制品分段生产试点工作方案》政策解读_2024_NMPA

2024-10-22

生物制品分段生产试点工作方案_2024_NMPA

2024-06-05

ICH HARMONISED GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS Q4B(R1) _ICH 2024

2024-05-21

ICH HARMONISED GUIDELINE DRUG INTERACTION STUDIES M12 _ICH 2024

2024-05-21

ICH HARMONISED GUIDELINE General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines M14 _ICH 2024

2024-01-31

Final Concept Paper S1B(R1) Testing for Carcinogenicity of Pharmaceuticals _ ICH 2024

2023-11-30

Final IWG Concept Paper Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin _ICH 2023

2023-11-01

ICH HARMONISED GUIDELINE VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN Q5A(R2) _ICH 2023

2023-11-01

ICH HARMONISED GUIDELINE ANALYTICAL PROCEDURE DEVELOPMENT Q14 _ICH 2023

2023-11-01

ICH HARMONISED GUIDELINE VALIDATION OF ANALYTICAL PROCEDURES Q2(R2) _ICH 2023

2023-05-19

GOOD CLINICAL PRACTICE (GCP) _ ICH 2023

2023-04-03

ICH HARMONISED GUIDELINE ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7(R2) _ICH 2023

2024-08-22

Draft guidance on Trofinetide_Solution_FDA_2024

2024-08-22

Draft guidance on Tofersen_Solution_FDA_2024

2024-08-22

Draft guidance on Teriparatide_Solution_FDA_2024

2024-08-22

Draft guidance on Tafluprost_Solution, Drops_FDA_2024

2024-08-22

Draft guidance on Sotagliflozin_Tablet_FDA_2024

2024-08-22

Draft guidance on Risperidone_For Suspension, Extended Release_FDA_2024

2024-08-22

Draft guidance on Pegcetacoplar_Solution_FDA_2024

2024-08-22

Draft guidance on Nirmatrelvir; Ritonavir_Tablet_FDA_2024

2024-08-22

Draft guidance on Nedosiran Sodium_ Solution_FDA_2024

2024-08-22

Draft guidance on Naloxone Hydrochloride _ Spray, Metered_FDA_2024