Developing The Harmonized CTD Module 3 Data For Australia And South Africa Markets With Europe For A Generic Drug Product Approval

Abstract

Introduction: The drive for improved regulatory systems and the establishment of a more effective regulatory framework in Australia
(AU) and South Africa (ZA) has been evident for the past two decades. Navigating through South African Health Product Regulatory
Authority (SAHPRA) and Therapeutic Goods Administration Australia (TGA) requirements poses a challenge for generic product
manufacturers while approaching market authorizations.
Objective: The present work was an attempt to understand the Australia (AU) and South Africa (ZA) specific additional data
requirement of Chemistry, Manufacturing and Control (CMC) in order to build Module 3 dossier and ensuring timely approval of
generic product in ZA and AU market.
Methodology: This research work was a mix of Applied, Conceptual and Empirical research types.
Results: With the adoption of a large number of EU regulations, it is easier to use most of the data generated for the EU market.
However, there is still extensive AU and ZA specific CMC requirements, as discussed and presented in this article, which must be
considered at the development and global dossier preparation stages to ensure swift and timely approval in AU and ZA.
Conclusion: It is imperative to identify, generate and present this additional data for AU and ZA, during global generic product
regulatory filing to save cost and timely approval of the generic products in ZA and AU. It is recommended to keep abreast with everchanging regulations in ZA and AU.