APEC Accelerates Regulatory Convergence for Life-Saving Medicines and Innovation


  • Published by the APEC Life Sciences Innovation Forum

APEC member economies, through the APEC Life Sciences Innovation Forum, have agreed to accelerate regulatory alignment of medical products over the next two decades, with the aim of protect the safety of people and make life-saving medical products available with the approval of the Vision 2030 and Strategic Framework of the Regulatory Harmonization Steering Committee (RHSC).

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

“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 the availability of important medical products, save public resources, attract investment, mitigate the corruption and improve the global position in each APEC. economy, ”said Dr. Michelle Limoli of the US Food and Drug Administration and forum co-chair Regulatory Harmonization Steering Committee (RHSC).

The recently approved vision and strategic framework will guide the steering committee over the next decade, including facilitating cooperation among medical product regulatory authorities, building human capacity in regulatory science among medical product regulatory staff, and promoting a coordinated approach to regulatory convergence and confidence among decision makers. at APEC.

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

The Steering Committee will also strive 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 such centers housed in 20 institutions in nine APEC economies aimed at building the skills and capacities of hundreds of regulators each year. The centers promote dialogue with a view to sharing scientific knowledge and best practices.

The impacts of these centers and other work carried out by the steering committee have been measurable. An annual review exercise shows that regulatory requirements for medical product approval are increasingly aligned across APEC economies over time.

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

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

“COVID-19 continues to show us how important it is for regulators and industry to work together to accelerate regulatory convergence,” said Dr. Michelle McConnell of the U.S. Department of Health and Human Services and chair of the APEC Life Sciences Innovation Forum. “A good political environment helps us to create a healthy society. A healthy society contributes to a healthy economy.

/ Public distribution. This material is from the original organization and may be ad hoc in nature, edited for clarity, style and length. See it in full here.


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