The World Health Organization (WHO) Regional Office for the Western Pacific will convene the Eleventh Meeting of the Regional Alliance of National Regulatory Authorities for Medical Products in the Western Pacific from 31 August to 1 September 2022 as a hybrid meeting in Manila, Philippines.
National regulatory systems safeguard public health by ensuring the safety, efficacy and quality of medical products, which is a cornerstone in achieving universal health coverage and the Sustainable Development Goals. National regulatory authorities (NRAs) are at the front line for ensuring the timely access and availability of critical products during public health emergencies. The Regional Alliance of NRAs of Medical Products in the Western Pacific, established in 2011, works to strengthen the individual capacity of NRAs, as well as to raise the overall level of regulation in the Region. At this stage of the coronavirus disease (COVID-19) pandemic and subsequent global economic recovery, some countries are focusing on local manufacturing of vaccines and medicines to address inequity and ensure sustainable access. This requires NRAs with the capacity to implement a full range of regulatory functions, including transitionary measures from emergency use authorizations to granting full marketing authorization of COVID-19 vaccines and therapeutics. Further strengthening is also needed for critical regulatory functions such as post-marketing surveillance to combat the rampant spread of substandard and falsified products and pharmacovigilance to assess medicines- and vaccine-related adverse events.
In the midst of these emerging issues, the Regional Alliance will gather to enhance cooperation on regulatory systems strengthening. Prior to the meeting, the Steering Committee will convene to refine the strategic objectives and plans of the Regional Alliance and propose revisions for 2023–2026 and to set the plan for committee membership renewal.
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.