Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific.

Abstract

Asia-Pacific is a region of fast growing opportunity for biomedical research and marketing of new health products by pharmaceutical and medical device companies. While national regulatory authorities have the responsibility to ensure timely access to innovative, effective, and safe therapies, many face capacity and resource constraints that limit their ability to guarantee a robust regulatory system capable of licensing and monitoring novel medicines and medical devices, and tackling substandard and falsified products. The region's regulatory landscape is also fragmented with country-specific requirements that create barriers to entry for new health products. To help address these challenges, the Duke-National University of Singapore's (Duke-NUS) Centre of Regulatory Excellence (CoRE) was established in 2014 with the strategic goals to strengthen the region's regulatory agencies through capacity development, regulatory convergence, work sharing, and nurturing networks for leadership and systems innovation. A smart and mature regulatory system in Asia-Pacific is pivotal to promote biomedical innovation and enhance equitable, sustainable access of populations to quality health products that are safe and efficacious.