CTD Quality Module 3 for new chemical and Generic products Chemistry, Manufacturing and Control (CMC) 23 February, 2021 Riyadh

The Pharmaceutical Development Module should describe the knowledge that establishes that the type of dosage form selected, and the formulation proposed are suitable for the intended use. This module should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process. CMC is an integral part of drug development, a regulatory submission and the on-going marketing and life cycle management of a medicinal product. As drug development of the dosage form moves from concept to commercialization, the breadth and depth of CMC documentation required in submissions increases in parallel.