How to Write and Evaluate a Common Technical Document

Module Objectives

The Common Technical document was formulated by the International Commission on Harmonisation (ICH) with the intention of facilitating the submission of all the data needed for registration of a medicinal product by the Regulatory Authority of the member countries of the ICH.

The objectives of this module are to:

  1. Enable students to understand the structure of the CTD document
  2. Evaluate the difference in approach to CTDs in large markets and smaller jurisdictions

Where applicable, consider issues from an Emerging Market perspective referring to the European Medicines Agency (EMA), the US Food and Drug Agency (FDA) and the International Conference on Harmonisation (ICH) regulations and initiatives

Intended Module Learning Outcomes

Write up a CTD and evaluate the same or different CTD.

Evaluate and compare the elements that are specific to the pharmaceutical industry of South Africa with those in organisations such as ICH and then also assist applicants (for registration) in the preparation of their dossiers, which are being developed, for different types of medicines including New Chemical Entities and Generics.

Contribute to discussions of various interest groups (such as ICH members) on changes to the current CTD