SUB04

Preparing Submissions in the Common Technical Document (CTD) Format

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European Economic Area, required for prescription drugs in Japan and elsewhere, and accepted by a growing number of other national regulators. Use of the electronic version of the CTD is mandatory for applications for marketing approval and all subsequent submissions in the USA. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

Approved by the Royal Society of Chemistry for purposes of continuing professional development.

Approximate Course Time: 1.5 hours

Level: Introductory/Intemediate

CPD Points: 1.5

Audience: Regulatory

Category: Regulatory Submissions

Region: USA, Europe, Other

Who will benefit from this module?

Regulatory affairs and compliance staff, and all those involved in drug development and who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool. Specialists in data handling, knowledge management or documentation will also wish to familiarise themselves with its contents.

Learning objectives

  • Explain the rationale for the CTD, and describe the ways in which it is used.
  • Identify regional differences in regulatory requirements for information in a CTD-formatted submission.
  • Describe the structure of the CTD.
  • Access guidance on detailed structure and content of the CTD.
  • Outline formatting requirements for a CTD dossier.
  • Convert EU NTA and US NDA section codes and headings to their CTD equivalents.

Module outline

Introduction – This session introduces you to the nature of the Common Technical Document (CTD), a global standard designed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The composition of a regulatory submission team is outlined. 

High-level structure – In this session you will become more familiar with the five modules of the CTD. 

Fine structure and format – You will be given access to guidelines that specify in detail the structure of each module of the CTD and the relationship between their sections and the documents that make up a dossier. Recommendations are also given on how to segregate and paginate documents and how to format pages, tables of contents and cross-references. 

Using the CTD – Different ways in which you can use the CTD in practice are described. Production of a CTD dossier in both paper and electronic format is outlined.

Conversion tools – Two tools allow you to convert section headings in the old EU NTA format or the US NDA format to their equivalents in the CTD.

Assessment – Multiple-choice mastery assessment.

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