Introduction

The timely availability of in-vitro diagnostics (IVDs) is a critical component of health services, enabling healthcare professionals to identify and diagnose conditions correctly and optimise treatments. Poor quality diagnostics and the lack of access to these health products directly impact the quality of health services and potentially increase the costs of national healthcare spending due to the ineffective management of diseases. 

As observed from the COVID-19 pandemic, differences in the health outcomes were linked to the equitable access to the needful health products including the IVD. There were calls to focus on local and regional manufacturing as well as improving the efficiency of regulatory approvals. The exponential growth of the medical technology sector in China, India, South Korea and Southeast Asia provides a viable option for many countries to fulfil their need for IVD and support the development of their health systems, particularly the low and middle income countries (LMICs).

The advantage of the Asia and pacific region’s population, intellectual resources, vast mass market, and integrated supply chain, make this area an ideal market for large volume and affordable innovation that can benefit the global health market. However, manufacturers in this area might not have aligned with the global regulatory requirements, therefore hindering the process of regulatory approvals and market access challenges. In addition, there are opportunities to further explore regulatory reliance approaches in improving the time for market approvals of health products.

With a focus on facilitating innovations for Asia and Pacific region, the Centre of Regulatory Excellence (CoRE) and Duke Kunshan University have partnered with the Gates Foundation and embarking on a newly established project "The CREATInG Initiative" This initiative will convene global and regional thought leaders across academic, developers and manufacturers to discuss regulatory and non-regulatory barriers for market access as well as develop executive thought leadership and regulatory functional skills among the IVD manufacturers entering global markets.

Global Health Impact

• Contribute to regulatory systems strengthening in the region
• Accelerate market access of essential IVDs to LMICs 
• Enhance quality of health services and management of diseases, which will lead to reduce healthcare spending