FDA eCTD TECHNICAL CONFORMANCE GUIDE
标准简介
eCTD TECHNICAL CONFORMANCE GUIDE[附网盘链接]由FDA于过去发布，适用于US。标准截图
![eCTD TECHNICAL CONFORMANCE GUIDE[附网盘链接]](/img/20210914103736xdcvl.jpg)
标准文档说明
标准文档类型为eCTD TECHNICAL CONFORMANCE GUIDE[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
eCTD TECHNICAL CONFORMANCE GUIDE This technical specifications document represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for implementing this specifications document by email at esub@fda.hhs.gov or esubprep@fda.hhs.gov. 1. Introduction 1.1 Background This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The Guide supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product 1
Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance). The eCTD Guidance implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain investigational new drug applications (INDs); new drug applications (NDAs); abbreviated new drug applications (ANDAs); certain biologics license applications (BLAs); and master files submitted to CDER or CBER. These submissions may apply to combination products with CDER or CBER as the lead 2
center. 1.2 Purpose This Guide provides technical recommendations to sponsors and applicants for the standardized electronic submission format of INDs, NDAs, ANDAs, BLAs, and master files. The Guide is intended to complement and promote interactions between sponsors and applicants and FDA’s electronic submission support staff. However, it is not intended to replace the need for sponsors and applicants to communicate directly with support staff regarding implementation approaches or issues relating to electronic submissions. Because of the inherent variability across studies and applications, it is difficult to identify all issues that may occur related to the preparation and transmission of electronic submissions. Therefore, prior to submission, sponsors and applicants should discuss questions with the appropriate center’s electronic submission support staff within the appropriate center — CDER: esub@fda.hhs.gov or CBER: esubprep@fda.hhs.gov. 1
A link to this document can be found on the FDA eCTD website (https://www.fda.gov/ectd) 2
See 21 CFR Pa rt 3. Combination products a re comprised of a ny combination of a drug a nd a medical device; a medical device a nd a biological product; a biological product a nd a drug; or a drug, a medical device, a nd a biological product. Combination products a re a ssigned to a lea d center for review; see 21 CFR 3.4.
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