Our Work – South-East Asia Regulatory Network

Action point	Lead WG	Need	Actions
1	2	Capacity building to support Members in achieving their objectives of Maturity Level using the Global Benchmarking Tool and/or WLA status	Continue the development of a sustainable capacity building offer in the prioritised domains of competency in relation with the countries’ tailored goals, including RCOEs Support the development of a capacity building platform for SEARN Support the finalisation and implementation of the expansion of the composition of WG2 (as needed) to support listing of training providers and a pool of trainers Pilot the development and implementation of a regional programme of GSDP workshops Organize a webinar to disseminate the SEARN strategy for capacity building, including to HR departments and universities/relevant training providers Develop a domain in the competency framework to support NRAs in ensuring safe medicines during pregnancy
2	N/A	Experience sharing	Active participation in the WG
3	4	Facilitate information Sharing	To set up a system for monitoring the progress on the national strategies to facilitate information sharing. Develop an MoU on sharing information with the target of signing it during the next meeting of the Assembly Address any challenge arising from the implementation of the outputs of action point 3
5	2	Facilitate reliance	Develop a strategy for reliance on marketing authorization of priority products Continue the mapping of reference NRAs Explore how to further consider WLAs in this strategy Propose means to address any issue arising in the scope of this strategy
8	1	Improve the use and access to reference standards	Support the development and implementation of a system to facilitate sharing and testing of samples between the SEARN NQCLs Support the finalisation and implementation of the expansion of the composition of WG1 (as needed) to support listing of suppliers of references standards and, if needed, their assessment To develop a strategy to ensure alignment between NQCL needs for primary reference standards and certified reference materials (CRM) and established regional and international producers and pharmacopoeias, collect and share information about official reference standards access programmes, and support convergence on the definitions of the different categories of reference standards To support Members in their risk-based approaches through identifying minimum standards for screening strategies To further develop the strategy for biological references standards
9	1	Strengthen collaboration between National Quality Control Laboratories to develop capacity	Develop an MoU to be signed during the next meeting of the Assembly Develop a sustainable training strategy (in coordination with AP1) Develop and implement a database on the capacity of SEARN NQCLs Develop a Regional list of reference Quality Control Laboratories Develop and pilot the system for collaborative testing of samples (including draft bilateral MoUs/contracts) and proficiency / inter laboratory testing with EG/DEG
12	4	Ensure preparedness against public health emergencies	Develop guidelines to NRAs to facilitate the implementation of the strategy. Support on any matter related to ensuring the preparedness of the Network.
15	3	Strengthen the capacity to assess and manage risks associated with medical products	Deepen the analysis of the survey on risk management and propose recommendations to SEARN, including engagement with stakeholders and capacity building Support the finalisation and implementation of the regional mechanism for risk assessment (including reliance) and the expansion of the composition of WG3 to support risk assessment (including the dedicated terms of reference, the nomination of additional experts, and the creation of an experts database) Pilot the regional mechanism for risk assessment with valproate
16	3	Develop a regional mechanism to detect and review safety signals	Initiate the regional monitoring of priority medicines by 1^st August 2024 Explore the expansion of priority medicines to vaccines and biologicals Support the finalisation and implementation of the expansion of the composition of WG3 to support signal assessment (including the dedicated terms of reference, the nomination of additional experts, and the creation of an experts database) Identify or develop trainings, guidelines and templates to support signal validation and assessment Deepen the description of the variables in the national ADR reporting forms’ and publish the results in a scientific paper Organize an in-person workshop with key stakeholders for in-depth discussions on how to strengthen pharmacovigilance in the region
17	5	Capacity building for medical devices, including IVD	Conduct a regional workshop on strengthening medical devices regulation To expand the competency framework To support the implementation of the capacity building strategy To support regulatory convergence and explore participation in international networks
18	5	Facilitate reliance for medical devices, including IVDs	Worksharing on identifying and mapping reference authorities and organisations for prioritised regulatory decisions for medical devices and where to find the information. Conducting a workshop on reliance for medical devices Any other action to support the implementation of reliance by SEARN Members
19	2	Strengthen the capacity of SEARN Members to address antimicrobial resistance	To develop a strategy to strengthen the capacity of SEARN Members to address antimicrobial resistance
20	4	Strengthen the capacity of SEARN Members to monitor and address shortages	To develop a strategy to strengthen the capacity of SEARN Members to monitor and address shortages
21	4	Strengthen Regulatory Information Management Systems to support information sharing	To develop a strategy to strengthen Regulatory Information Management Systems to support information sharing