APEC Strengthens Regulatory Convergence to Accelerate Medical Product Access in Asia-Pacific
SDG 3: Good Health and Well-being | SDG 9: Industry, Innovation, and Infrastructure
Institutions: Ministry of Commerce and Industry | Ministry of Health and Family Welfare
APEC economies have achieved measurable progress in regulatory convergence for medical products, as confirmed by new Key Performance Indicators endorsed by the Regulatory Harmonization Steering Committee (RHSC). This cooperation aims to streamline drug and device approval processes, reduce redundant reviews, and significantly lower costs across the Asia-Pacific region. Officials noted the progress accelerates patient access to safe, high-quality products and strengthens international confidence in regulatory systems by minimizing duplication and corruption opportunities. The RHSC is now refining its indicators and promoting expanded multi-regional clinical trials to enhance the availability of new therapies, including orphan drugs for rare diseases.
For India, participation in regional and global harmonization efforts led by groups like APEC is crucial to boosting its pharmaceutical exports to the Asia-Pacific. Aligning domestic regulations with international best practices strengthens the credibility of the Central Drugs Standard Control Organisation (CDSCO) and can expedite the entry of innovative global therapies into the Indian market.
What is Regulatory Convergence? β This is the process by which different countries and regional blocs, like APEC, align their technical regulations and procedures for approving products such as medicines and medical devices. The goal is to establish mutual acceptance and reliance on other trusted regulatorsβ assessments, speeding up market entry while strictly maintaining public safety and quality standards.
What is the Regulatory Harmonization Steering Committee (RHSC)? β The RHSC is a committee under the Asia-Pacific Economic Cooperationβs (APEC) Life Sciences Innovation Forum, established to promote regulatory convergence for medical products, including pharmaceuticals and medical devices, across APEC economies. Its mandate is to facilitate trade and accelerate patient access by building regulatory capacity through Centers of Excellence (CoEs) and encouraging mutual recognition of standards among regional authorities
Relevant Question for Policy Stakeholders: How can India leverage its ongoing Free Trade Agreement negotiations with APEC economies to formalize mutual recognition agreements for medical products?
Follow the full news here: https://www.apec.org/press/news-releases/2025/apec-advances-regulatory-convergence-for-medical-products