Our Work – South-East Asia Regulatory Network

Action point	Lead WG	Need	Actions (2023-2024 work plan)	Summary of the outputs from the previous work plans
1	2	Capacity building to support Members in achieving their objectives of Maturity Level using the Global Benchmarking Tool and/or WLA status	Pilot the development of a sustainable capacity building offer in the prioritised domains of competency in relation with the countries’ tailored goals. Map capacity building actions conducted by the Network.	Strategy to support capacity building for SEARN members (July 2023)
2	N/A	Experience sharing	Active participation in the WG
3	4	Facilitate information Sharing	Define the minimal information required for routine administrative information. Propose a format for sharing ad hoc urgent information between Members. Address any challenge arising from the implementation of the outputs of action point 3 of the 2022-2023 work plan.	Strategy to facilitate information sharing, including establishing channels of communication and processes (July 2023)
4	4	Define the needs that the public website and internal platform should address	Provide feedback and recommendations on the deployment and development of the internal platform.	N/A
5	2	Facilitate reliance	Converge on the minimum information required for each decision for reliance. Worksharing on identifying and mapping reference authorities and organisations for prioritised regulatory decisions for medicines and vaccines and where to find the information. Initiate work on reliance for market control and surveillance for medicines and vaccines.	Strategy to facilitate reliance, especially in the region (July 2023)
6	2	Ensure the sustainability of the network and the workplan	Action point concluded during the 2022-2023 work plan.	Strategy to review possible funding sources in order to ensure the sustainability of the network and support the workplan (July 2023)
7	1 2 3 4 5	Share lessons from the COVID-19 experience in the region	Address the gaps identified in this work through the action points already proposed in the 2023-2024 workplan including dedicated sessions in the relevant working group to share good practices with other countries, and complement the summary published on the SEARN website with this experience	Document compiling and reviewing the COVID-19 experience of NRAs to improve regulatory preparedness (July 2023)
8	1	Facilitate the identification needed and sharing of reference material/chemical reference standard, including for COVID-19 medicines	Organisation of a regional workshop dedicated to building capacity on the optimal use of reference standards. Develop a regional mechanism to facilitate the evaluation of suppliers of reference standards. Develop a system to facilitate sharing and testing of samples between the SEARN NCLs Conduct a feasibility study on developing the production of secondary pharmaceutical reference standards.	Strategy to improve access and use of reference standards (July 2023)
9	1	Facilitate the comparison of laboratories in the region to improve performances	Develop and pilot a regional collaborative capacity development programme between NCLs, including capacity building for the supporting NCL and identification of funding mechanisms Develop and pilot a worksharing mechanism on establishing a list of reliable laboratories	Strategy to Improve the Quality Management System of National Quality Control Laboratories (July 2023)
10	3	Increasing the number of reports	Action point concluded during the 2022-2023 work plan.	Strategy to stimulate reporting in the region, including technical solutions (July 2023)
11	3	Support integration for vigilance	Action point concluded during the 2022-2023 work plan.	Strategy to support integration for vigilance (July 2023)
12	4	Regulatory intelligence and sharing of key information and standards in times of public health emergency	Develop guidelines to NRAs to facilitate the implementation of the strategy. Prepare a map of sources of information in times of public health Ensure the preparedness of the SEARN secretariat	Strategy to support regulatory intelligence in times of public health emergency, including adequate considerations for resources (July 2023)
13	5	Facilitate the assessment of gaps in medical devices regulation in the Member States	Action point concluded during the 2022-2023 work plan.	Review of the gaps in medical device regulation (July 2023)
14	1	To ensure the integrity of excipients and healthcare products throughout the supply chain	Implement the strategy agreed during the 2022-2023 workplan	Strategy to ensure the integrity of excipients (July 2023)
15	3	Develop the capacity to assess risk management plans	Draft a strategy to strengthen the capacity to assess risk management plans at the regional level
16	3	Optimize the use of the vigilance reports collected	Develop a regional mechanism to detect and review safety signals, including through collating and analysing reports from different countries
17	5	Capacity building for medical devices, including IVD	Draft a strategy to support capacity building to regulate medical devices, including IVDs
18	5	Facilitate reliance for medical devices, including IVDs	Draft a strategy to facilitate reliance for medical devices, including IVDs