You are here

CTD Module 1

3 August 2020

Book pagination

Introduction

Terminology

Regulatory activity category

Regulatory activity category is identified by a number, for example, Category 1 and Comparable Overseas Regulator (COR) report-based applications, and refers to the overall legislated time-frames for decisions about regulatory activities.

Regulatory activity type

Regulatory activity type relates to the fees associated with an application and is identified by a letter, for example, A, B or C applications.

Examples include:

  • new chemical entity
  • new indication.

Sequence

A sequence is a package of information bundled together in an electronic structure providing information to the agency. The contents of a sequence will depend on the regulatory activity type and whether it is the initial sequence of the regulatory activity or a follow-up providing additional data or changes (see also Module 1.0.2 Lifecycle tracking table).

Common technical document (CTD)

The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the TGA in 2004.

The CTD prescribes:

  • the organisation of the dossier across five modules
  • the order in which documents must appear so they are grouped logically and can be easily located.

Under the CTD format:

The format and content of Module 1 (Administrative information and prescribing information for Australia) are described in this document.

The electronic Common Technical Document (eCTD) is the electronic version of the CTD and is described by the following documents:

Book pagination