Regulatory Harmonization Building Skilled Human Capacity
in Regulatory Sciences

The Challenge

Regulators and industry alike recognized that a lack of skilled human capacity within regulatory authorities hinder their ability to bring life-saving and life-enhancing medical products to the people and patients who need them. In response, health officials within the Asia-Pacific Economic Cooperation (APEC) forum set out to create an institutional approach – that is inclusive and could be implemented across the region – to improve regulators’ capacity and training, promote international best practices, and ultimately drive regulatory convergence from country to country.

Why CMI?

C&M International was asked to design a self-sustaining, scalable model to build the skilled human capacity of regulatory authorities because of our experience convening stakeholders – including government officials and the companies they regulate – and our substantive healthcare policy expertise.

What We Did

C&M International worked with regulators and industry to create a joint vision for a network of Centers for Excellence (CoE) for Regulatory Science within APEC’s Regulatory Harmonization Steering Committee (RHSC) and its Life Sciences Innovation Forum (LSIF). CMI gained substantive buy-in from all stakeholders, developed and executed a successful pilot, and subsequently was the prime mover in establishing the CoE network.

The CoE network is now regarded as a vitally important tool to build regulator capacity, strengthen regulatory institutions across the Asia-Pacific region, and enable regulators to implement international standards. To assure the success of this groundbreaking, multi-stakeholder initiative, the CMI team worked with partners to:

• Design an innovative model that leverages the hosting and funding capabilities of universities, research centers, and science organizations.

• Recruit CoE host institutions, including Duke-NUS Singapore, Peking University, Northeastern University, the University of Southern California, and others.

• Create operating procedures to ensure that a common curriculum reflecting the latest international standards is deployed consistently across the CoE network.

The Outcome

There are now more than a dozen CoEs across several APEC economies, including China, Singapore, the United States, Japan, and Korea. In all, they host more than 20 workshops and reach hundreds of regulators each year. By promoting understanding and use of international standards, these efforts have improved the regulatory ecosystem and have enabled regulatory convergence across the region. 

To learn more about how C&M International crafts innovative strategies and unique public-private partnerships to drive regulatory harmonization across a range of industries and sectors, please contact Patty Wu (pwu@crowell.com), Andrew Blasi (ablasi@crowell.com) or Eric Obscherning (eobscherning@crowell.com).