What is eCTD compliance?
eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically.
What is eCTD in pharma?
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.
What is eCTD dossier?
The eCTD dossier is the collection of files, data and information that are required to be contained in an eCTD drug submission by a regulatory body. An eCTD dossier is more commonly called a new drug application (NDA) in the U.S. and a marketing authorization application (MAA) in the European Union and other countries.
Why is eCTD important?
Advantages of the eCTD Structure Local affiliates can review updates in real-time. FDA reviewers can review faster and more efficiently, shortening time to approval. Handling, managing, and archiving trial and document-essential information is less time-consuming. Documents are easily accessible via search and tracking.
When did eCTD become mandatory?
National procedure (NP): eCTD mandatory from 1.7. 2018 for new MAA and from 1.1. 2019 for all submissions.
What is dossier publishing?
Core Capabilities. CTD, eCTD, NeeS, VNeeS and eCopy support. Dossier life cycle management. eCTD sequence and metadata management. Robust hyperlinking and bookmarking.
When does FDA begin to use eCTD validation?
FDA plans to implement eCTD validation checks when submissions contain content under modules 4 and 5 beginning September 15, 2021. Submissions which fail this validation will be subject to rejection. Please see the Technical Rejection Criteria for Study Data and the eCTD Validation Criteria (error code 1734, 1735, 1736, 1789) for details.
When did mandatory ECTD format come into force?
In accordance with the eSubmission Roadmap, Mandatory eCTD format is also stepwise introduced for National Procedures. eCTD validation criteria v7.1 and Release notes – 02.03.2018. Entered into force on 1st of September 2018.
What are the important notices related to eCTD?
A list of important notices related to eCTD submissions. This collection includes forms for applications and submissions, reports and accountability, certifications, and inspections. Technical Rejection Criteria for Study Data (PDF – 92KB) New!
Which is the eCTD standard for the EU?
More information about the standard can be found at the ICH eCTD webpage. For eCTD submissions within EU, the EU Module 1 eCTD Specification (see link below) should be used. The eCTD format is mandatory to use for all submission types related to Marketing Authorisation for products within all EU procedures (i.e.