Building capacity of national regulatory functions for medical products
Sharing information, expertise and best practices
Partnership and resource mobilization to support resource-limited NRAs
Strengthening medicines and vaccines' regulations
The Thirteenth Meeting of the Regional Alliance of National Regulatory Authorities for Medical Products in the Western Pacific was held in Manila, the Philippines from 13 to 15 August 2024.
National regulatory authorities (NRAs) for medical products are crucial for protecting public health by ensuring the quality, safety and efficacy of medical products. Access to quality medical products is fundamental to achieving universal health coverage (UHC) and other health-related Sustainable Development Goal (SDG) targets. NRAs are dealing with new regulatory challenges due to the evolving coronavirus disease (COVID-19) pandemic and the increasing presence of substandard and falsified medical products (SFMPs). These global challenges require coordinated actions by NRAs.
The Regional Alliance of National Regulatory Authorities for Medical Products in the Western Pacific
Region aims to promote and support strategies to strengthen the capacities of NRAs by promoting
cooperation, reliance and effective regulation. The twelfth meeting of the Regional Alliance served as
a forum for NRAs to develop a strategic plan for 2023–2026 to address the identified priorities and
respond to emerging regulatory issues and challenges.
The Regional Alliance Steering Committee and Eighth Workshop for NRAs were convened in Tokyo, Japan from 27 to 29 August, hosted by the MHLW and PMDA of Japan. A total of 21 countries and areas as well as development and technical partners represented the workshop. WPRO's Operational Shifts were introduced as framework and guidance for discussions towards levelling up the performance maturity of regulatory systems in countries. The meeting closed with convening the Regional Alliance General Assembly (RAGA) which unanimously agreed on the following:
Countries to submit expression of interest for membership in the Regional Alliance's Technical Working Groups (TWGs) which would cover: a) marketing authorization and regulatory inspections; b) quality control laboratory capacity; c) pharmacovigilance and post-marketing surveillance; d) regulatory preparedness for public health emergencies;
Develop protocol for reliance between/among NRAs;
Define pathways for medical products for emergencies;
Share information and collaborate on alerts and recalls for substandard and falsified medical products;
Work together for a common framing for regulatory policy for local pharmaceutical production.
