|The Life Sciences Innovation Forum – Regulatory Harmonisation Steering Committee Meeting at APEC’s Third Senior Officials Meeting (SOM-3) held on August 18 in HCM City was attended by 74 delegates from 18 APEC economies. . VNS Photo Hoàng Nam|
HCM CITY – Greater convergence among APEC members’regulatory systems for medical products is expected to improve public safety and patient access to life-enhancing medical products, experts said at a forum at the APEC Senior Officials Meeting (SOM-3) held in HCM City on Friday.
The co-chair of the forum, Toshiyoshi Tominaga, who is associate executive director for the Pharmaceuticals and Medical Devices Agency’s International Programs and Asian Training Centre, said the Regulatory Harmonisation Steering Committee (RHSC) aimed to promote regulatory convergence and drug innovation in the APEC region.
“We have discussed reports from our representatives and on our priority work areas and supply chains. The committee has made good progress but we need to evaluate the progress of the convergence, which has not been easy to measure,” he said.
A strategic framework for regulatory convergence for medical products by 2020 is expected to achieve greater uniformity within APEC.
It would facilitate exchange of information among regulators to improve safety and efficacy of medical products, create more efficient regulatory processes, and align regulatory requirements to promote public health and innovation.
Adopted in 2010 by the RHSC and the Life Science Innovation Forum in Japan, the framework provides the basic proposal and rationale for achieving regulatory convergence for medical products within the APEC bloc by 2020.
Its aim is to outline a strategic multi-year approach to meet the objective in support of the broader objectives of improved public health and economic development.
Each economy will determine the level of convergence it desires, develop specific strategies to promote regulatory convergence, and set a timetable in the context of its own regulatory system and socio-cultural objectives.
While each economy may adopt each phase in its own timeframe, the ultimate aim is for APEC economies to achieve maximum regulatory convergence by 2020.
The forum was attended by 74 delegates from 18 APEC economies. -- VNS