Abstract

REGULATORY OVERVIEW OF POST APPROVAL CHANGES OF THERAPEUTIC PRODUCT IN SINGAPORE

Rishal Relita Mendonca* and Sumana D. R.

ABSTRACT

Post approval changes can be addressed as specific changes implemented during the product lifecycle in a stepwise approach to get better, faster and accurate results by the company as per the norms set by the regulatory agency which is based on the proposed plan and test to verify that there is no change in product quality. Singapore which is regulated by Health Sciences Authority (HSA) addresses post approval change as a variation which can be major variation or minor variation. Health Sciences Authority (HSA) has clearly defined the regulatory framework for post approval changes with appropriate guidelines and checklists. This article depicts the overview of post approval changes in Singapore which includes the classification, submission procedurewith target timelines and fees, data requirements, steps in selecting the suitable variations by the applicant.

Keywords: Post approval changes, major variation, minor variation, HSA, MAV, MIV