Public
Regional Alliance Steering Committee and Eighth Workshop for NRAs for Medical Products in WPR
27-29 August 2019, Iino Conference Hall; afternoon of 29 August Visit to PMDA Tokyo, Japan
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.
- Posted by Socorro Escalante and Jinho Shin