Your Excellency Lyonpo Tandin Wangchuk, Health Minister, Bhutan
Chair of this Assembly, Mrs. Gyem Bidha
Heads of National Regulatory Authorities
Representatives of Member States
Development Partners, and
WHO Colleagues
Good afternoon, and welcome to the annual meeting of the Assembly of the Members of the South-East Asia Regulatory Network (SEARN).
First of all, I would like to thank the Ministry of Health of Bhutan, and Mrs. Gyem Bidha, for hosting this meeting.
Bhutan has long been strongly engaged in this Member-States-led network. You have actively participated in the meetings, and in multiple drafting groups. You have also volunteered to pilot the development of the first Regional Center of Regulatory Excellence, dedicated to regulatory quality management systems.
I also applaud your strong commitment to strengthening regulatory systems. These systems are critical to ensuring all people have access to safe, effective, affordable essential medical products, and for achieving universal health coverage.
The theme selected by Bhutan for this Assembly is ‘Regulatory excellence: Achieving Balance of quality and accessibility to medical products for all.’
Since the last meeting of the Assembly in Dhaka in July 2024, SEARN has been extremely active with many meetings of the steering group, working groups, and drafting groups. Multiple surveys have been undertaken, and workshops conducted.
These efforts are bearing fruit. There is a mature SEARN memorandum of understanding between National Regulatory Authorities (or NRAs), which is under review by your governments.
National quality control laboratories now have access to a database characterizing their capacity, to enable collaboration and facilitate training.
The SEARN competency-based training catalogue platform is finally under development, and the programme of training for Good Storage and Distribution Practices inspectors has been initiated.
WG3 now benefits from the support of 15 independent experts, and the first safety signal and safety issue are under review.
SEARN safety alerts are now being shared between national regulatory authorities.
The preparedness strategy has successfully been piloted with Mpox, and NRAs have benefitted from a forum to discuss regulatory issues and centralize supporting resources.
NRAs also initiated their self-assessment with the global benchmarking tool for medical devices regulation, and SEARN is finalizing its application to the International Medical Device Regulators Forum.
I congratulate you on your efforts and achievements and encourage you to continue addressing challenges to your collaboration, particularly with information sharing.
I would like to reaffirm WHO’s continued support for this Network for as long as you require it. This commitment of ours materialised in the development of a Quality Management System to support our role as secretariat.
I would also like to commend partners from the Coalition of Interested Parties for all their support during the past workplan, which has been essential to the results achieved.
Please also join me in welcoming at this year’s Assembly, our partners and colleagues from the Asian Development Bank, the U.S. Food and Drug Administration, and the Western Pacific Regional Alliance of NRAs for Medical Products. We are looking forward to our discussions with you, and to future collaborations.
We do face challenges ahead. As we all know, resources have become scarcer and may put the sustainability of this Network at risk. To maintain and develop SEARN, we will need to find ways to mobilize financial and human resources from your NRAs and partners. I hope you will use this Assembly to explore how to do this.
Over the next two days, you will be presented with the outputs of the work that was conducted during this year, and the status of the SEARN Monitoring and Evaluation Framework. I urge you to actively participate in these discussions, to ensure that the time invested by your staff in this network benefits your own National Regulatory Authority and serves the interests of your country.
I wish you all success and look forward to being appraised of the outcomes.
I hope you enjoy your stay in beautiful Bhutan and get a chance to immerse yourselves in the unique culture and landscape around you.
Thank you.