Understanding The Safety Strategies And Regulatory Considerations Of Drug Development In The JAPAC Region

By Hye Jin Choi, R. Ph., Senior Director of Regulatory Affairs and Drug Development Solutions, IQVIA Asia Pacific; and Dr. Jayawant Fuke, Senior Director of Lifecycle Safety, IQVIA

The Japan and Asia-Pacific (JAPAC) biopharma market continues to grow rapidly. Global funding for emerging biopharmas (EBPs) in China has consistently grown with a compound annual growth rate of over 20%. EBPs made up 75% of the total clinical trial volume in JAPAC in 2020, and the JAPAC contract research organization (CRO) market is forecasted to grow by more than $6 billion in the next five years. While CROs, pharma companies, and patients will benefit from this growth, it is critical to understand the market’s challenges and nuances to be successful and compliant.

Though there are several regulatory distinctions for Japan and China, with the right experts and technology on hand, integration will be seamless. ICH adoption across the region is helping to ensure that global drug programs are viable for companies and compliant for regulatory authorities. If you are considering launching a drug program in the burgeoning JAPAC market, download the full whitepaper to start familiarizing yourself with the regulatory nuances and initiatives across the region.