2019年8月20日,美国食品药品监督管理局(FDA)向中国浙江某非处方药(OTC)制造商发出了一封警告信,内容涉及CGMP数据记录造假,数据可靠性等违规行为。在警告信中,FDA代理局长Ned Sharpless博士说:“确保(药物)这些产品的质量和安全性是FDA作为公共卫生机构的最大责任之一。近年来,FDA已将额外的资源集中用于预防、发现和...
eCTD, Nees and CTD submissions and its life cycle management solution suite by ensuring compliance with regulatory guidelines and regional specifications.
USFDA eCTD v4.0 Implementation Package History v1.1 美国FDA eCTD v4.0 实施包历史 v1.1 USFDA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.1 美国FDA 模块1 eCTD v4.0 实施指南 v1.1 2017.2.20 This document only includes the specification information for eCTD v4....
The electronic Common Technical Document (eCTD) is currently the standard format for submission of regulatory applications, amendments, data, and reports to the FDA. The FDA is also requiring that electronic data from some nonclinical studies be submitted with applications. The data submission must ...
21 CFR Part 11, the U.S. Food and Drug Administration (FDA) Annex 11, computer guidelines for the EU's Good Manufacturing Practices. Good Laboratory Practices. Good Manufacturing Practices 2. PFSB 040122, the Japanese guideline. International Standards Organization (ISO) 9001. ...
eCTD is “highly recommended” by the FDA Single application format for all applications Required by EMEAfor centralized procedures Easier decision-making process Increaseddocument granularity eCTD is the only acceptable format for new electronic submissions to CDER and DBER. ...
21 CFR Part 11, the U.S. Food and Drug Administration (FDA) Annex 11, computer guidelines for the EU's Good Manufacturing Practices. Good Laboratory Practices. Good Manufacturing Practices 2. PFSB 040122, the Japanese guideline. International Standards Organization (ISO) 9001. ...
21 CFR Part 11, the U.S. Food and Drug Administration (FDA) Annex 11, computer guidelines for the EU's Good Manufacturing Practices. Good Laboratory Practices. Good Manufacturing Practices 2. PFSB 040122, the Japanese guideline. International Standards Organization (ISO) 9001. ...
For complete details on how to meet the eCTD requirement, refer to the FDA’s eCTD Guidance. Where can I learn more about the actual eCTD dossier submission process? For a list of resources and a breakdown of the individual steps reviewers will need to follow for an eCTD dossier submission...
The Thai FDA’s application review timeline will also likely be shortened. Thailand’s eCTD program is based on International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), European Union and Canadian specifications and gu...