Bridging The Gap: Breaking APAC Into The US FDA Market

By Jonathan Helfgott, MS, Co-founder, Healthcare Innovation Catalysts, Former Associate Director for Risk Science, US FDA, CDER; Mathew Thomas, MBBS, Ph.D., Senior Regulatory and Clinical Advisor, Healthcare Innovation Catalysts, Former Director of US FDA India Office, Senior Policy Advisor US FDA, CDER.

Clinical research opportunities in the Asia-Pacific (APAC) region have experienced significant growth, with over 50% of global clinical trials now being conducted in this region. Countries like Japan, South Korea, Singapore, and Taiwan offer several advantages, including a large and diverse population, technological expertise, cost-effectiveness, and higher engagement in recruitment and retention efforts. However, there is still untapped potential in the APAC region for the development of novel therapeutics and medical devices.

For APAC countries to successfully enter the U.S. biopharma market, they must navigate the regulatory processes and adhere to the established standards of care. Whether they are developing a new product for the U.S. market or launching an existing product, APAC companies need to have a comprehensive strategy and access to the right expertise to ensure success.

One key aspect for APAC companies is finding the right partners and prioritizing due diligence. By partnering with experienced organizations and conducting thorough research, APAC companies can avoid delays in clinical trials and product launches.

Although the APAC region presents significant opportunities for clinical research and the development of innovative therapeutics and medical devices, with a better understanding, see how APAC companies can successfully enter the U.S. biopharma market and achieve their goals.