In accordance with its strategy (AP12) on preparedness, SEARN triggered for the first time its coordinated response mechanism to a situation of concern or a public health emergency, in response to mpox.

During its meeting on 28 August 2024, the extended Steering group of SEARN considered that a coordinated response from the Network was required to address mpox and requested the creation of a dedicated working group to ensure the preparedness of the Network.

SEARN Members indicated that potential areas where the ad hoc working group may support include information sharing, authorisation of vaccines, medicines, and diagnostics, clinical trials, pharmacovigilance, communication, and laboratory reagents.

The ad hoc working group is planned to have its first meeting in the upcoming weeks.

Outputs from the 2023-2024 workplan

During this meeting, the Assembly adopted the outputs from the 12 action points of the 2023-2024 workplan, including:

WG1 Quality

• SEARN defined its vision for collaborative testing in the region, which will be piloted for testing for ethylene glycol / diethylene glycol (EG/DEG) - link

WG2 Regulatory Strengthening

• SEARN defined its vision to support a sustainable capacity building strategy aligned with the global competency framework, which will start to be implemented during the 2024-2025 workplan, including a pilot programme of in-country Good Storage and Distribution Practices (GSDP) workshops - link
• SEARN agreed on the minimum information required for reliance, which will be made available by NRAs within two years - link

WG3 Vigilance

• SEARN established a regional mechanism for monitoring priority medicines and providing recommendations to SEARN Members on safety issues

WG4 Information Sharing

• SEARN noted with satisfaction that the system for sharing ad hoc urgent information is now functional, and 3 alerts were shared in the past workplan - link
• SEARN Members will develop national strategies to address obstacles to information sharing and regularly discuss the progress in SEARN - link
• SEARN may now trigger a coordinated response to a situation of concern or a public health emergency, complementing the international health regulation - link

WG5 Medical Devices

• SEARN developed a competency framework for medical devices (pre-marketing) - link
• SEARN agreed on the minimum information required for reliance, which will be made available by NRAs within two years, and on the possible criteria for selecting a Reference Regulatory Authority - link

Safe medicines during pregnancy

In line with the theme selected by Bangladesh for this Assembly, and informed by two dedicated sessions, the Assembly decided that SEARN will:

• Develop a domain in its competency framework to support NRAs in ensuring safe medicines during pregnancy
• Pilot the regional mechanism for recommendations on risk management with valproate
• Include pregnancy adverse events in the priority list for monitoring /detection at the regional level

Other decisions from the Assembly   

• Bhutan will host the next meeting of the Assembly in 2025, and Nepal in 2026
• Adoption of the results of the monitoring and evaluation framework for the 2023-2024 exercise, and the recommended changes in the framework. The Assembly noted some positive impact, but more time and efforts are required to achieve the goals set by the strategies
• Adoption of the SEARN 2024-2025 workplan (please refer to Our work and the Working Groups for more information), including three new action points dedicated to:
  • Antimicrobial resistance
  • Shortages
  • Regulatory Information Management Systems
• SEARN adopted a quality policy to initiate its quality management system and ensure continuity and sustainability of the Network
• SEARN agreed to initiate work towards the establishment of a dedicated working group on traditional products
• Adoption of the revised Terms of reference (v7) to enable participations of experts external to NRAs to support scientific / technical recommendations from WGs, and to allow for a gradation of responses to public health emergencies.

The meeting of the Assembly of the Members of the South-East Asia Regulatory Network (SEARN) was held in Jakarta, Indonesia from 26-27 July 2023, and preceded by meetings of all working groups and the Steering group on 24-25 July 2023.

During this meeting, the Assembly decided on:

1. The adoption of the outputs from the 14 action points of the 2022-2023 workplan. The public summaries of these outputs can be accessed through the table included in the Our work section.
2. The establishment of a Coalition of Interested Parties (CIP) at the regional level to further support the activities of the Network through close collaboration with the development partners.
3. The adoption of the SEARN 2023-2024 workplan (please refer to Our work and the Working Groups for more information)
4. Updating the SEARN terms of reference (v.6) including a specific section to ensure the preparedness of the Network in case of public health emergency
5. Setting up a Monitoring and evaluation framework to verify the impact of the actions from SEARN
6. Bangladesh to host the next meeting of the Assembly in 2024;
7. Sri Lanka to join the Steering group in replacement of the Maldives.

More information can be found here about the work of the Assembly.

Among the 14 outputs from the 2022-2023 workplan, the Assembly adopted a strategy to strengthen information sharing. This strategy specifically includes:

1. A declaration from the Members of SEARN to facilitate information sharing (please see below) and reaffirm their commitment to strengthening information sharing.
2. A customizable template of Confidential Disclosure Agreement to facilitate bilateral sharing of confidential information.
3. Guidelines to SEARN members on Information Sharing.

More information can be found in the public summary: Action Point 3: Strategy to facilitate information sharing.

We, the Members of the South-East Asia Regulatory Network (SEARN) participating in the 2023 Assembly of the Members of SEARN in Jakarta, Indonesia

Recalling the 2018 Delhi declaration on improving access to essential medical products in the South-East Asia Region and beyond, in which the Ministers of health of the 11 Members States from the WHO South-East Asia Region agreed on the proposed mandate to ‘Continue the momentum to strengthen regulatory cooperation and collaboration to improve the availability, quality and safety of essential medical products through the South-East Asia Regulatory Network (SEARN)’.

Recalling the Network’s first objective as stated in the Terms of Reference (version 5, June 2022) to share information through creating ‘an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities between NRAs in the region’.

Acknowledging that all Members benefit from accessing information from other Members, which is a pre-requisite for reliance, building trust, and facilitating international trade, and is in urgent cases an ethical duty to protect public health.

Considering that information sharing can also be a means to support capacity building in the region and to monitor progress in strengthening regulatory systems for all medical products.

Concerned that, despite the objectives of the Network, the information shared between the Members has remained insufficient, which may lead to sub-optimal regulatory decisions and use of the limited resources of our National Regulatory Authorities (NRAs).

Reaffirming our commitment to create an enabling environment to enhance communication and information sharing between NRAs in the region.

 

HEREBY agree to the following:

1. Reaffirm our commitment to facilitate information sharing between the Members of the Network.
2. Communicate to other Members urgent information required to protect public health and facilitate access to such information from authorities not directly involved in SEARN as needed.
3. Develop and implement Guidelines to SEARN Members to facilitate information sharing, including establishing channels of communication and processes between SEARN members.
4. Encourage SEARN Members to share confidential information through any appropriate means to be defined by the parties, including through the establishment of bilateral Confidential Disclosure Agreements (CDA).
5. Encourage SEARN Members to publish non-confidential information required by other Members to implement reliance.
6. Promote exchange of information related to WHO global benchmarking and WLA assessment among SEARN members to support capacity building, reliance, and to monitor progress in strengthening regulatory systems for all medical products.
7. Request the Steering group, Working groups, and secretariat to propose means and conditions to the Assembly to implement the aforementioned actions and measure the impact.
8. Promote the implementation of the agreed actions in the internal Quality Management System and processes by adequate communication to the staff and with other authorities in the country.
9. Review the progress of the implementation of the agreed actions to promote information sharing during the next Assembly of the Members of SEARN.

Adopted by the Members in Jakarta, Indonesia, on 27 July 2023.