June 25, 2021

APEC accelerates medical product regulatory convergence

Through the APEC Life Science Innovation Forum, member countries of the Asia-Pacific Economic Cooperation (APEC) have agreed to accelerate regulatory harmonization for medical goods over the next two decades.

According to a statement issued by the APEC Life Science Innovation Forum and received here on Wednesday, the effort to expedite matters was made in order to protect people’s safety and make life-saving medical products available, with the endorsement of the Regulatory Harmonization Steering Committee (RHSC) Vision 2030 and Strategic Framework.

The Regulatory Harmonization Steering Committee, which was established in 2009, is a network of regulatory professionals from throughout the APEC area, including regulatory agencies, industry actors, and academics.

The steering group selects priority work areas in the pharmaceutical and medical device industries where member countries think regulatory convergence would benefit them.

“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 corruption, and improve global standing in every APEC economy,” said Michelle Limoli of the US Food and Drug Administration, who is also the co-chair of the APEC Medical Products Working Group.

The steering committee will be guided by the recently approved vision and strategic framework for the next decade, which includes facilitating cooperation among medical product regulatory authorities, developing human capacity in regulatory science among medical product regulatory staff, and promoting a coordinated approach to regulatory convergence and reliance among policymakers in the APEC region.

“The adoption of this document comes at a critical moment as members seek to integrate lessons from the Covid-19 (coronavirus disease 2019) pandemic and confront a new generation of innovative medical goods,” said Nobumasa Nakashima, co-chair of the steering group.

Building on previous achievements, such as the APEC Training Centers of Excellence for Regulatory Science, the steering group will also seek to develop and incubate new concepts to drive regulatory convergence.

Currently, 29 of these centers are housed in 20 institutions in nine APEC countries, with the goal of improving the skills and capacity of hundreds of regulators each year.

The centers encourage discussion in the quest of scientific knowledge and best practices.

The effect of these centers, as well as the steering committee’s other efforts, has been quantifiable.

The regulatory criteria for the licensing of medical goods are getting increasingly harmonized across APEC countries over time, according to an annual assessment exercise.

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

“In this ever-changing context, policies must be well-coordinated, logical, and complementary, particularly in the face of a pandemic or crisis. Governments can only accomplish this by allowing various voices in the room, as well as engaging other agencies and sections of society at the table “she said.

Michelle McConnell, chair of the APEC Life Science Innovation Forum, said the Covid-19 epidemic continues to demonstrate the need of regulatory agencies and industry working together to promote regulatory convergence.

“A healthy society leads to a strong economy,” McConnel added.

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