The Asia-Pacific regulatory systems are diverse and can be challenging to navigate without insights on recent developments and an understanding of the regulations to determine the most efficient strategy to obtain approval from each regulatory body. This session will focus on the key markets of Australia and India and provide an overview of recent regulatory agency developments to enhance efficiencies and provide flexibility including the introduction of new pathways, RA CMC regulatory requirements, collaborative initiatives with international regulators, exemptions, and clinical trial reform to speed up the drug approval processes for prescription and orphan-designated medicines. The session will include industry data and real-life case studies to showcase decision making to determine the optimal registration strategy.
Learning Objectives:
Describe the recent regulatory reforms that have occurred in Australia and India to expedite the drug development and approval processes
Determine which pathways to utilize to optimize registration of prescription medicines in Australia.
Understand the meaning of unmet medical needs and consider India as one of the major markets for launching medicines for serious and life-threatening diseases.