Our Work – South-East Asia Regulatory Network (SEARN)

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	To finalize the development of the SEARN capacity building platform in consultation with SEARN members Continue the establishment of the Regulatory QMS RCOE, develop its curriculums and initiate trainings Continue the implementation of the SEARN GSDP training programme and initiate the development of the GSDP RCOE Develop a SEARN GMP training programme and initiate the development of the GMP RCOE Organize a webinar to disseminate the SEARN strategy for capacity building, including to HR departments and universities/relevant training providers
2	N/A	Experience sharing	Active participation in the WGs Arrange a presentation from WG4 in WG6 on the SEARN strategy for information sharing and identify actions required for traditional medical products and means of implementation Arrange a presentation from WG3 in WG6 on the SEARN strategies on vigilance, identify actions required for traditional medical products and means of implementation
5	2	Facilitate reliance	Organize a workshop with industry to finalise the SEARN convergence mechanism Pilot the SEARN convergence mechanism Continue learning from the experience of other regulatory networks Explore means to further develop the worksharing mechanism Develop and implement a survey intended for WLAs in order to continue the mapping exercise and explore possibilities to access non-public information for SEARN members Propose means to address any issue arising in the scope of this strategy
6	2	Ensure the sustainability of the network and the workplan	Document SEARN’s current challenges and opportunities Propose means to reduce costs to ensure the sustainability of the Network and its activities Propose a resource mobilization strategy to support the activities of the Network Identify means to reduce or share some of the activities from the secretariat
8	1	Improve the use and access to reference standards	To continue the engagement with the International Meetings of World Pharmacopoeias To conduct interviews with the identified reliable producers of reference standards To identify or develop risk-based approaches for prioritised tests through identifying minimum standards for screening strategies To conduct one or several workshops to better characterise the needs of SEARN members regarding biological reference standards and define the related strategy of the Network
9	1	Strengthen collaboration between National Quality Control Laboratories to develop capacity	Pilot the system to facilitate sharing and testing of samples between SEARN NQCLs Pilot the sharing of quality test results Pilot the establishment of a regional centre of excellence for laboratory testing Pilot the development of a training programme for impurity testing, including EG/DEG Continue the development of a proficiency / inter laboratory testing programme for EG/DEG
12	4	Ensure preparedness against public health emergencies	Consider the conclusions of the mpox Intra action review to strengthen the regulatory preparedness of SEARN and its members. Consider the recommendations from ICDRA 2024 in the SEARN strategy. The secretariat should develop an SOP to describe the roles, responsibilities and processes supporting its function in the scope of this strategy.
15	3	Strengthen the capacity to assess and manage risks associated with medical products	Conduct a survey to collect information about available legal provisions for managing risks Develop recommendations to support Members in managing the risks of medical products according to their capacity Develop the capacity of SEARN members in managing risks (including RMP assessment) Pilot the establishment of a regional centre of excellence for pharmacovigilance Develop a mechanism to facilitate reliance for risk management in SEARN Address any emerging issue related to this strategy
16	3	Develop a regional mechanism to detect and review safety signals	Explore the expansion of priority medicines to vaccines and biologicals Finalise the publication on mapping variables in the national ADR reporting forms Engage with policy-makers on how to strengthen pharmacovigilance in the region Pilot the establishment of a regional centre of excellence for pharmacovigilance Develop a mechanism to facilitate reliance for safety signals in SEARN Address any emerging issue related to this strategy
17	5	Capacity building for medical devices, including IVD	To support the implementation of the capacity building strategy (AP1), prioritizing the assessment of manufacturers’ QMS To pilot the development of a Regional Center of Excellence for medical devices/IVDs To organize a regional workshop on the pre marketing assessment and market surveillance of IVD, ideally in 2025 To identify or develop models of documents to support capacity building at organizational level To develop a system for information sharing on medical devices regulation activities in SEARN and beyond To support regulatory convergence and explore participation in international networks and organizations, such as MDSAP and IMDRF To organize presentations in WG5 on current issues, such as borderline products, recommissioned/refurbished medical devices, risk-based classification of Software as Medical Devices
18	5	Facilitate reliance for medical devices, including IVDs	Review the SEARN competency framework for medical devices and identify capacity building resources to support reliance Develop an information sharing mechanism to support reliance in connection with AP3 Information Sharing and AP21 RIMS Discuss and develop a proposition, as needed, to pilot convergence workshops for medical devices (including in vitro diagnostics) in connection with AP5 reliance. Develop a programme of presentations to WG5 from reference organizations on their regulatory systems and how to use their generated information for reliance
19	2	Strengthen the capacity of SEARN Members to address antimicrobial resistance	Identify an existing forum or develop a forum of discussion between policy makers and NRAs on addressing sales of antimicrobials without prescription Engage with other stakeholders to support the development of an IT tool to facilitate effective and standardized AMC data collection Organize presentations to share experience in WG2 including on effective sanctions Development communication material for pharmacists Development of examples of standard wording for antimicrobials and check list/template for considering AMR during retail store inspections Publish the results of the survey and interviews in a peer-reviewed journal
20	4	Strengthen the capacity of SEARN Members to monitor and address shortages	To conduct a survey to collect current definitions related to shortages and existing mechanisms to address these in SEARN members To develop a system to compile, analyse and share information related to shortages at SEARN level to support Members in forecasting, reducing and averting shortages/stockouts To learn from the experience and best practices of SEARN members and other regions / organizations in addressing shortages, including public procurement agencies (e.g. iCAPS) To develop collaboration with public procurement agencies to support the development and implementation of the SEARN strategy To support SEARN Members in addressing shortages through capacity building, including at the organizational level (e.g. legal provisions, clear responsibilities, tools)
21	4	Strengthen Regulatory Information Management Systems to support information sharing	Plan and initiate the development of a network of interoperable RIMS enabling collaboration and, when decided by NRAs, the automatic sharing of some information for Marketing authorizations and convergence/harmonization of related standards Develop or identify a domain in the SEARN competency framework to strengthen NRA staff IT literacy Develop and initiate the implementation of a sustainable and cooperative regional approach to the development of RIMS Publish the aggregated results of the survey in a peer-reviewed journal
22	6	Capacity building for traditional medical products	Identify/develop guideline on capacity building at organizational level for the regulation of traditional medical products Develop and implement a survey on gaps in traditional medical products regulation and identification of existing legal provisions and guidelines Initiate the development of a regional competency framework for the regulation of traditional medical products Prioritize the needs of the SEARN members in terms of capacity building Identify key stakeholders for capacity building of the regulation of traditional medical products including the WHO International Regulatory Cooperation for Herbal Medicines (IRCH) Support the implementation of the SEARN capacity building strategy (AP1)
23	6	Convergence of the regulation of traditional medical products	Identify and prioritize areas for convergence of the policies and regulation of traditional medical products Propose a work method for convergence of the policies and regulation of traditional medical products including engagement with the WHO International Regulatory Cooperation for Herbal Medicines (IRCH) Develop and implement a survey on gaps in traditional medical products regulation and identification of existing legal provisions and guidelines Optimize the participation from the region in the annual survey on the Traditional and Complementary Medicines Monitoring and Evaluation Framework