REGULATORY HARMONIZATION STEERING COMMITTEE
The Life Sciences Innovation Forum (LSIF) was established by the leaders of Asia-Pacific Economic Cooperation (APEC) to lead APEC initiatives on health and health sciences innovation. It is a tripartite forum that engages representatives from the highest levels of government, industry and academia to create the right policy environment for life sciences innovation.
The Regulatory Harmonization Steering Committee (RHSC) was formed in June 2009 under the auspices of the APEC LSIF to promote a strategic approach to regulatory harmonization by undertaking activities of greatest value to regulatory authorities and regulated industries. It is a network of regulatory experts from regulatory agencies in APEC economies, industry and academia with the vision of achieving greater regulatory convergence within the APEC economies by 2020.
The RHSC does not seek to develop new guidances but is designed to play a complementary role to other regional international regulatory initiatives.
Each economy determines the level of convergence it desires and develops specific strategies to promote regulatory convergence based on a timeline in the context of its own regulatory system and socio-cultural objectives. The efforts of the RHSC are guided by the Strategic Framework which outlines a strategic multi-year approach with the vision of achieving greater regulatory convergence within the APEC economies by 2020.
The RHSC identifies Priority Work Areas (PWA) in the medical product sectors of pharmaceuticals and medical devices where member economies believe would benefit from regulatory convergence. Roadmaps for each PWA are developed by PWA Champions in consultation with member economies, industry and academia based on an understanding of the regulatory best practices already being undertaken, an assessment of ways to improve convergence and a detailed plan to fill the gaps through education and regulatory revision. Training Centers of Excellence for Regulatory Science (CoE) are then commissioned by the RHSC to meet the training needs of member economies in the Priority Work Areas.