Dr Samanta Lal Sen, Minister of Health & Family Welfare, Bangladesh
Dr Rokeya Sultana, State Minister of Health & Family Welfare, Bangladesh
Mr Md Jahangir Alam, Secretary, Ministry of Health & Family Welfare
Chair of this Assembly, Major General Mohammad Yousuf,
Heads of National Regulatory Authorities,
Representatives of our Member States,
Development Partners,
Colleagues from Headquarters, Regional and Country Offices,
Good afternoon, and welcome to this 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 Bangladesh Ministry of Health & Family Welfare, and Major General Mohammad Yousuf, the Directorate General of Drug Administration (DGDA), for hosting this meeting.
The location of this Assembly meeting is not an accident as over the last years, Bangladesh has demonstrated very strong leadership in this network, chairing two of the working groups, actively participating in the meetings, and endorsing the role of rapporteur for three important action points.
Bangladesh has demonstrated its long-term commitment to strengthening its regulatory system, its will, to collaborate with other regulators, and its commitment to contribute to addressing global issues such as contaminations of oral liquid medicines. All of these are clear values underpinning the Good Regulatory Practices. I have no doubt that Bangladesh will soon become a solid and trusted Regulatory Authority, which will in turn facilitate global exports of its well-developed local industry of quality and affordable medical products.
Strong regulatory systems are a critical condition to ensure access for all people in the region to safe, effective, quality and affordable essential medical products, and achieving universal health coverage, a key aim of the 2018 Delhi Declaration on improving access to essential medical products.
Since the last meeting of the Assembly in Jakarta in July 2023, WHO has continued supporting countries in strengthening their regulatory systems. This has been through the use of the Global Benchmarking Tool for medicines and vaccines to assess the system’s performance, providing recommendations through institutional development plans, and follow-ups on the progress. It has included the development of a conceptual model to achieving effective regulation of medicines and vaccines by national regulatory authorities with very limited resources, which will soon be published. I am also pleased to know that a regional workshop is being planned to expand these efforts to the regulation of medical devices, which are as critical and essential as medicines and vaccines. I encourage you all to continue these efforts and expand the use of the global benchmarking tool to medicines, medical devices and blood products regulatory systems.
As you all well know, no single regulator, even in High-Income Countries, can fulfil all its regulatory missions without collaboration from other regulators.
This is the essence of this regional network. SEARN has become a very active network of over 100 experts from NRAs, WHO and partners, building trust and mutual understanding between regulators, and addressing common challenges. As of today, there have been three meetings of the steering group, 15 meetings of the working groups, and over 50 meetings of the drafting groups to implement the 2023-2024 workplan. I commend your efforts towards implementing global principles in our region, and developing original solutions, whenever required, to best address the needs of all of its Members.
Thanks to the responsiveness of the Network, the region has been at the forefront of the response to the outbreak of contaminated oral liquid medicines. It has adopted a dedicated strategy to ensure the integrity of excipients, organized a dedicated regional workshop in Indonesia, and a regional virtual workshop on testing methods for the contaminants in oral liquid medicines for National Regulatory Authorities in October 2023. The virtual workshop was attended by 168 participants from 20 countries, and shortly after, Maldives identified contaminated products using the presented method from the International Pharmacopoeia. This triggered the first SEARN regional safety alert, a subsequent global medical product alert, and withdrawals of products in five countries worldwide. I would like to acknowledge this success and congratulate the Network for this achievement.
I have noted that the collaboration with development partners has significantly strengthened through the establishment of a regional Coalition of Interested Parties and this close collaboration has led to promising discussions on how to pursue our common efforts in a sustainable manner. This meeting also offers an opportunity to express our gratitude to Australia’s TGA (Therapeutic Goods Administration), CEPI (Coalition for Epidemic Preparedness Innovations), MTaPS (The Medicines, Technologies, and Pharmaceutical Services) Program, the Northeastern University, and the United-States Pharmacopoeia (USP), in addition to PATH, the Uppsala Monitoring Centre, and the International Society of Pharmacovigilance (ISoP), for their support throughout the year.
Moreover, I am delighted that DGDA has decided that the theme of this year’s Assembly would be ‘Safe medicines during pregnancy’. This is an essential topic, too often neglected, which can have dramatic consequences on women, children and families. Investing in women, girls, adolescents and vulnerable populations is very close to my heart, and one of the key roadmap components in our WHO South-East Asia Regional Roadmap for Results and Resilience.
During this meeting today and tomorrow, you will be presented the outputs of the work that was conducted during this year, and it is encouraging to see that there is now a clear vision on how to build NRA staff capacities in an effective and sustainable manner. Please actively participate in the discussions to ensure that the time invested by your staff in this network benefits your own National Regulatory Authority.
While it is still early to observe the impact of the adopted strategies, as shown by the Monitoring and Evaluation Framework, you will see that the working groups have proposed for your review clear directions for the future to address critical challenges.
I cannot overstate that the main and central challenge which SEARN Members still need to resolve is information sharing. This is key for reliance, preparedness, regional work sharing on pharmacovigilance, ensuring the integrity of excipients, among other needs expressed by your NRAs. I have faith in your commitment to make this possible. If you feel it is very important to access some information, then it is very important for you to also share this information. It is only on this condition that the efforts from SEARN will be successful.
I would like to convey, once more, the intention of our WHO South-East Asia Regional Office to support this important Network. My office has initiated the development of a Quality Management System (QMS). This will allow us to formalize and institutionalize our support through the creation of a Secretariat. This will ensure continuity of support, and I should point out that the Secretariat will operate in consultation with SEARN Members. As a first step, this Assembly will discuss and adopt the quality policy, which will serve as a foundation for this QMS.
Members, participants, colleagues, and friends,
Over the course of this meeting, you will review the outputs of each of the working groups, discuss the proposed strategies, and decide on its strategic orientations for the next year.
Based on your conclusions, the drafting groups will immediately start working on the new workplan.
I urge you to fully engage and contribute to the discussions and look forward to the outcomes.
I wish you all success and reiterate WHO’s ongoing and unmitigated support to support this Network.
Thank you.