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.
Regulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and efficacious products quickly to patients. APEC established the Regulatory Harmonization Steering Committee (RHSC) to advance this cause among member economies. This paper identifies four areas of appropriate regulatory practice in which APEC economies could converge, and explores the feasible processes of how APEC economies could cooperate in order to bring about realization of a maximum level of regulatory convergence by 2020.
Every medicines and medical device national regulatory authority operates within finite resource constraints, with smaller agencies in low-and-middle-income countries disproportionately affected. The Singapore Health Sciences Authority has been pragmatic and open to regulatory innovation, without compromising commitment to public health and science-based decision making. Its experiences and approach are described as a case study for eliciting principles that may be helpful to addressing challenges in global regulatory capacity development.