Abstract

STUDY ON REQUIREMENTS OF CHANGE IN SOURCE OF API ACROSS EUROPEAN UNION AND EMERGING MARKETS

Sita Priya Darsini Yallabandi*, Ravi Kumar Reddy Juturi and Basava Raju D.

ABSTRACT

Post-approval changes/variations is defined as changes in of any aspect of a pharmaceutical product after approval which includes but is not limited to manufacture process changes, packaging changes, labelling changes, finished product changes, API changes, excipient changes, etc. Among all these variations, this study is focusing on the impact on source change of API and its regulatory requirements in different regions/countries like Europe & Emerging markets (ASEAN, GCC, African). While changing API source, alternate Supplier selection plays a major role which includes quality assessment, audits, evaluation of the API, and compliance to regulations. Each country defined some conditions and document requirements for approval of variations which varies from country to country. The study focuses on similarities and differences for post-approval change in API source. Some similarities include classification of the type of variation, submission of the application process, the update of the dossier, etc. Differences highlighted across the type of application form, timelines, and fees for approval of the variation. A comparison table for all the countries/regions for documentation requirements is included in this study. This study aims to understand how the variations implemented in each country and how it differs from country to country.

Keywords: Variation. API, Regulations, Countries.