What is Module 1 of an eCTD compliant submission?

What is Module 1 of an eCTD compliant submission?

Module 1 contains administrative, labeling, and promotional material documents. The subject matter for each document should be assigned to the lowest level of the hierarchy outlined in the associated FDA technical specification Comprehensive Table of Contents Headings and Hierarchy available on our eCTD website.

How many modules are there in ICH CTD structure?

five modules
The CTD is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guidance should ensure that Modules 2 through 5 are provided in a format acceptable to the regulatory authorities.

What countries use eCTD?

The countries which are accepting eCTD submissions are:

  • US FDA.
  • European Medicines Agency (EMA)
  • Japan.
  • Health Canada.
  • Swissmedic.
  • China eCTD adoption.

Does FDA accept paper submissions?

Non-commercial IND submissions (including investigator-sponsored INDs and expanded access INDs) are exempt. After these deadlines, paper submissions or electronic submissions that are NOT in eCTD format will NOT be filed or received unless exempt from the requirement.

When did eCTD become mandatory?

Is the eCTD Format Mandatory? One question you may have is whether or not the eCTD format is mandatory….

Submission Type Compliance Date
NDAs, ANDAs, BLAs May 5, 2017
Commercial INDs, Master Files May 5, 2018

What is the eCTD specification?

The eCTD specification lists the criteria that will make an electronic submission technically valid. The focus of the specification is to provide the ability to transfer the registration application electronically from industry to a regulatory authority. Industry to industry and agency to agency transfer is not addressed. Background

What does eCTD stand for?

This guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities (hereafter referredto as NCAs) and the European Medicines Agency (hereafter referred to as EMA).

What version of eCTD do I need for electronic submissions?

Electronic submissions must use the version of eCTD currently supported by FDA, which is specified in the FDA Data Standards Catalog on the Study Data Standards Resources page. Updates to the standard will be announced on the FDA website and published in the Federal Register.


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