跳至主要内容

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 Purposes3
2. Submission Components of Clinical Trial Data4
2.1 Study database4
2.2 Analysis database5
2.3 Data Definition File6
2.4 Annotated CRF7
2.5 Programming Code7
3. Submission Document Format and Conventions8
3.1 Portable document format8
3.2 Extensible mark-up language format8
3.3 Plain text format8
3.4 Data transport file format8
3.5 Dataset split9
3.6 Dataset name, variable name and length9
3.7 Dataset labels and variable labels10
4. Other Considerations10
4.1 Traceability of trial data10
4.2 Data files under eCTD11
4.3 Foreign language database11
4.4 Communication with regulatory agency11
References11




Guideline on the Submission of Clinical Trial Data
1. Background and Purposes

Clinical trial data is one of the important materials submitted by sponsor to regulatory agencies. It is a valuable resource for both regulatory ag…

2020.4 NDA/BLA Inspection Schedule by CFDI for NMPA

April 2020 NDA/BLA Inspection Schedule by CFDI for NMPA:

No.Acceptance numberCompanyProducts1CXSS1900005 Xinjiang Deyuan BioengineeringHuman Immunnglnhlobulin (pH4) for Intravenous Injection2CXSS1700033 Shanxi Kangbao BiologicalHuman coagulation factor Ⅷ 3CYHS1900202 Chongqing Huapont PharmAminosalicylate  Enteric-CoatedGranules4CXHS1800035 Yichang Humanwell PharmaRamimazolam Besilate for Injection 5CXSS1800029 Heibei Daan Pharma Human Immunnglnhlobulin (pH4) for Intravenous Injection6Y20190000075 Chongqing Huapont Kaisheng PharmAminosalicylate 7CYSB1800230 Beijing Kawin Technology Recombinant Human Interferon α2b Injection 8CYSB1800229 Beijing Kawin Technology Recombinant Human Interferon α2b Injection9CYSB1800228 Beijing Kawin TechnologyRecombinant Human Interferon α2b Injection10CYSB1800231 Beijing Kawin TechnologyRecombinant Human Interferon α2b Vaginal Effervescent Tablets11CXSS1900029 Heibei Daan Pharma Human Prothrombin Complex 12CXSS1800007 China Biologic Products Human coagul…