APEC Accelerates Regulatory Convergence for Life-Saving Medical Products and Innovation

  • Issued by the APEC Life Science Innovation Forum

APEC member economies through the APEC Life Science Innovation Forum agreed to accelerate regulatory alignment for medical products over the next two decades, in a bid to protect people’s safety and make lifesaving medical products available with the endorsement the Regulatory Harmonization Steering Committee (RHSC) Vision 2030 and Strategic Framework.

Established in 2009, the Regulatory Harmonization Steering Committee is a network of regulatory experts from regulatory agencies, industry players and academics across the APEC region. The steering committee identifies their priority work areas in the medical product sectors of pharmaceuticals and medical devices where member economies believe would benefit from regulatory convergence.

“We will work together to accelerate regulatory convergence for medical products in the APEC region so that we can improve the safety of our people, ensure availability of important medical products, save public resources, attract investment, mitigate corruption and improve global standing in every APEC economy,” said Dr Michelle Limoli of the United States’ Food and Drug Administration and the co-chair of the forum’s Regulatory Harmonization Steering Committee (RHSC).

The recently endorsed vision and strategic framework will guide the steering committee over the next decade, including to facilitate cooperation among medical product regulatory authorities, build human capacity in regulatory science among medical product regulatory staff and promote a coordinated approach to regulatory convergence and reliance among policymakers in APEC.

“The endorsement of this document comes at a crucial time as members look to incorporate lessons from the COVID-19 pandemic and address a new wave of innovative medical products,” said Nobumasa Nakashima of Japan Pharmaceuticals and Medical Devices Agency, who are also the co-chair of the steering committee.

The steering committee will also work to innovate and incubate new ideas to accelerate regulatory convergence, building on past successes such as the APEC Training Centers of Excellence for Regulatory Science. There are currently 29 of these centers hosted at 20 institutions across nine APEC economies aiming to build skills and capacity for hundreds of regulators each year. The centers promote dialogue with a view toward knowledge sharing in science and best practices.

The impacts of these centers and other work done by the steering committee have been measurable. An annual evaluation exercise shows regulatory requirements for the approval of medical products are becoming more aligned among APEC economies over time.

“Regional organizations like APEC play an important role in facilitating discussion, sharing best practices and innovative regulatory approaches to emerging technologies and business models, including in medical and pharmaceutical sector,” said Dr Rebecca Sta Maria, Executive Director of the APEC Secretariat.

“In this ever-changing environment, especially with a pandemic and crisis, policymaking has to be well-coordinated, coherent and complementary,” Dr Sta Maria added. “The only way that governments can do this is by allowing different voices in the room, involving different agencies and different parts of societies at the table.”

“COVID-19 continues to show us just how important it is for regulatory authorities and industry to collaborate to accelerate regulatory convergence,” said Dr Michelle McConnell of the United States Department of Health and Human Services and the chair of the APEC Life Science Innovation Forum. “Good policy environment helps us to achieve healthy society. A healthy society contributes to a healthy economy.”

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