STUDY ON POST APPROVAL SOURCE CHANGE OF API IN THE FINISHED PRODUCT AND ITS REGULATORY REQUIREMENTS IN EU AND US:(TJPS-2020-0067.R2)

Abstract

Post approval changes are changes to any characteristic of pharmaceutical product after approval. Certificate of suitability of European Pharmacopoeia (CEP) and Drug Master File (DMF) are two mechanisms for API registration. Regulatory requirements vary for each mechanism. This study focused on regulatory requirements for post approval API source change in EU and USA; and to delve on the mechanism of post approval API source changes in USA and EU. To improve quality of the API, most of the pharmaceutical industries concentrate on CEP certified source instead of DMF as CEP assures compliance to standard and compliance to GMP as well. DMF to CEP source change is considered as minor change as it provides more assurance toward standard and quality whereas CEP to DMF source change is considered as major change because of no assurance of standard compliance in both countries. Differences observed by this study includes approval procedure, timeline and fees for approval; similarities are observed classification of variation but the terms used for each class differ. In both the countries, CEP is preferred over DMF to improve quality of the product and to assure its safety.

:TJPS-2020-0067.R2