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博文

目前显示的是标签为“NMPA”的博文

Guideline on the Submission of Clinical Trial Data in China (2020.5 Draft for Public Review)

Guideline on the Submission of Clinical Trial Data (Draft for Public Review) Center for Drug Evaluation, NMPA May, 2020 Table of Contents 1. Background and Purposes 3 2. Submission Components of Clinical Trial Data 4 2.1 Study database 4 2.2 Analysis database 5 2.3 Data Definition File 6 2.4 Annotated CRF 7 2.5 Programming Code 7 3. Submission Document Format and Conventions 8 3.1 Portable document format 8 3.2 Extensible mark-up language format 8 3.3 Plain text format 8 3.4 Data transport file format 8 3.5 Dataset split 9 3.6 Dataset name, variable name and length 9 3.7 Dataset labels and variable labels 10 4. Other Considerations 10 4.1 Traceability of trial data 10 4.2 Data files under eCTD 11 4.3 Foreign language database 11 4.4 Communication with regulatory agency 11 References 11 Guideline on the Submission of Clinical Trial Data 1. Background and Purposes Clinical trial data is one of the important mate

2020.4 NDA/BLA Inspection Schedule by CFDI for NMPA

 April 2020 NDA/BLA Inspection Schedule by CFDI for NMPA: No. Acceptance number Company Products 1 CXSS1900005  Xinjiang Deyuan Bioengineering Human Immunnglnhlobulin (pH4) for Intravenous Injection 2 CXSS1700033  Shanxi Kangbao Biological Human coagulation factor Ⅷ  3 CYHS1900202  Chongqing Huapont Pharm Aminosalicylate  Enteric-CoatedGranules 4 CXHS1800035  Yichang Humanwell Pharma Ramimazolam Besilate for Injection  5 CXSS1800029  Heibei Daan Pharma  Human Immunnglnhlobulin (pH4) for Intravenous Injection 6 Y20190000075  Chongqing Huapont Kaisheng Pharm Aminosalicylate  7 CYSB1800230  Beijing Kawin Technology  Recombinant Human Interferon α2b Injection  8 CYSB1800229  Beijing Kawin Technology  Recombinant Human Interferon α2b Injection 9 CYSB1800228  Beijing Kawin Technology Recombinant Human Interferon α2b Injection 10 CYSB1800231  Beijing Kawin Technology Recombinant Human Interferon α2b  Vaginal Effervescent Tablets 11 CXSS1900029  Heibei Daan Pharma  Human Prothr