Comparison of Asia Markets – Case Study for the Landscape in Post-Approval Changes/Variations

Various Asia countries have different regulations for post approval CMC changes which can lead to customization of submissions and challenges to implementation of changes. This presentation will provide a brief update on the evolving requirements for post approval CMC changes in Asean markets as well as comparing to the requirements in Korea, India, Taiwan, and China. An example of a CMC change will illustrate the differences and challenges between the markets. Understanding the requirements and how they are evolving helps manufacturing to more effectively plan submission content and manage approval timelines. Participants will understand general expectations for submissions of post approval changes in various Asian countries and the evolving landscape and where regulators are proposing changes to expectations.