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.
