Assembly of the Members of SEARN

Minutes for the meeting on 3-4 July 2024, Dhaka, Bangladesh

Theme:
Safe medicines during pregnancy

Chair: Major General Muhammad Yousuf (Bangladesh)

Members: Mr Md Mohammad Mozammel Hossain Khan (Bangladesh), Mr Md Abdul Aziz (Bangladesh),

Mr Mohammad Nayeem Golder (Bangladesh), Ms Gym Bidha (Bhutan), Mr. Jigme Dorji (Bhutan), Dr.
Rajeev Singh Raghuvanshi (India, Chair of Working group 3 Vigilance), Dr Manish Kapoor (India), Dra.
Togi Junice Hutadjulu (Indonesia), Mrs. Nunning Lestin Bintari (Indonesia, Chair of Working group 5
Medical Devices), Ms. Aishath Mohamed (Maldives), Mr. Mohamed Fazeen (Maldives), Mr. Narayan
Prasad Dhakal (Nepal), Mr Pan Bahadur Kshetry (Nepal), Dr Ananda Wijewickrama (Sri Lanka), Ms
Deepika Bulathsinghala (Sri Lanka), Dr. Tharnkamol Chanprapaph (Thailand), Mrs. Sirinmas Katchamart
(Thailand), Mr Delfim Costa Xavier Ferreira (Timor-Leste), Dr Jimmi Bruno de Oliveira (Timor-Leste)
SEARN Secretariat: Dr Anil Chawla, Mrs. Naina Sethi, Dr Adrien Inoubli
Other participants: Dr Md. Harun-Or-Rashid (Chair of Working group 1 Quality), Dra. Tri Asti Isnariani (Chair of
Working group 2 Regulatory Strengthening), Mr A.T.M. Golam Kibria Khan (Chair of Working group 4 Information
Sharing), Mr Md Ashraf Hossain (Bangladesh), Dr Md Akter Hossain (Bangladesh), Dr Sarwat Jahan Pia
(Bangladesh), Ms Gulshan Jahan (Bangladesh), Mr Shaikat Kumar Kar (Bangladesh), Mr Md Razibul Habib
(Bangladesh), Ms S M Sabrina Yesmin (Bangladesh), Mr Md. Mohid Islam (Bangladesh), Mr MD Shariful Islam
(Bangladesh), Mr Mir Abdur Razzaq (Bangladesh), Mr Nahin AI Alam (Bangladesh), Dr Hamida Begum (Bangladesh),
Mr Tanvir Ahmed (Bangladesh), Mr Md Salahuddin (Bangladesh), Mr Pravin Jagtap (India), Dr Santosh Vithalrao
Indraksha (India), Mr. V. Rajappan (India), Dr Vivekanandan Kalaiselvan (India), Mrs Indah Zulhijma Wattiheluw
(Indonesia), Mrs Anggrida Saragih (Indonesia), Ms Putri Wiyana Utami (Indonesia), Ms Aishath Jaleela (Maldives),
Ms K N L Karunathilaka (Sri Lanka), Mr Kritsada Limpananont (Thailand), Mr. Wittaya Prachachalern (Thailand), Mr
Wittawat Viriyabancha (Thailand), Mr Placido Bruno dos Reis Da Costa (Timor-Leste), Dr Jeremy Shonberg (TGA),
Dr Natasha Brockwell (TGA), Mr Matthew Scotney (CEPI), Mr Vivian Rakuomi (MTaPS), Mr. Mehmood Anwar
(TGA), Mr Esakky Jeyakhandan (USP), Mrs Tabassum Munira (USP), Mrs Topha Shrestha (USP), Dr Andrea Keyter
(WHO), Mrs. Chinta Abayawardana (WHO), Ms. Liyana Rakinaturia (WHO), Dr Md Khurshid Alam Hyder (WHO), Dr.
Mohamed Mahmoud Mahmoud Amine (WHO), Mr. Paritosh Chakma (WHO), Dr Samvel Azatyan (WHO), Dr
Shanthi Narayan Pal (WHO)

3 July
Time Agenda item Lead
(Dhaka)
09:00 Opening address WR Bangladesh on
behalf of the Regional
Director (TBC)

09:10 Speech from Secretary, MOHFW, Bangladesh Md. Jahangir Alam

Assembly - Minutes of the meeting on 3-4 July 2024 Page 1 of 8

 Secretary, MOHFW

09:15 Speech from honourable State Minister, MOHFW, Dr. Rokeya Sultana
Bangladesh
Honourable State
Minister, MOHFW,
Bangladesh

09:25 Speech from honourable Minister of Health & Family Welfare, Dr. Samanta Lal Sen
Bangladesh
Honourable Minister
MOHFW, Bangladesh

09:35 Vote of Thanks Major General

Mohammad Yousuf
Director General, DGDA

09:40 Introduction of the participants, and update on countries not Chair and Secretariat
participating in this meeting

The meeting was opened by addresses from the Regional Director of WHO South-East Asia Regional
Office, Ms. Saima Wazed, read by the WHO representative in Bangladesh, Dr Bardan Jung Rana, the
Secretary of the Ministry of Health and Family Welfare (MOHFW), Mr. Md. Jahangir Alam, the
honourable State Minister, MOHFW, Dr. Rokeya Sultana, the honourable Minister of Health & Family
Welfare, Dr. Samanta Lal Sen, and a vote of thanks from Major General Mohammad Yousuf, Director
General, DGDA and Chair of the Assembly. The honourable guests welcomed the delegates of the
Assembly, and highlighted the importance of SEARN to strengthen health systems and achieve
universal health coverage through access to affordable, quality, safe and effective medical products.
The Assembly was informed by the Secretariat that:
 the government of DPR Korea was not able to nominate participants for this meeting

WHO, as secretariat of SEARN, was not able to liaise with the government of Myanmar for this
meeting.

09:50 Group photo

10:00 Latest global developments in medical products regulation WHO HQ

Dr Samvel Azatyan

The Assembly was informed about the Latest global developments in medical products regulation in a
presentation from Dr Samvel Azatyan, covering the importance of reliance, Regulatory System
Strengthening activities, and WHO Listed Authorities (WLAs).

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 10:25 19th International Conference of Drug Regulatory Authorities India and WHO HQ
(ICDRA), 14 - 18 October, 2024, in New Delhi, India
Dr Rajeev Singh
Raghuvanshi and Dr
Samvel Azatyan

Dr Rajeev Singh Raghuvanshi and Dr Samvel Azatyan informed the Assembly about the 19th
International Conference of Drug Regulatory Authorities (ICDRA) which will be held in New Delhi,
India, from 14 to 18 October 2024, and invited SEARN Members to participate.

10:30 Regulatory collaboration expectation for new vaccine WHO SEARO

introduction in the region – presentation and discussion
Dr Anil Chawla

Dr Anil Chawla described the process of introduction of a new vaccines and the challenges in the
region, and highlighted the importance of reliance, streamlining regulatory processes, and
collaboration to ensure timely access to quality, safe and effective vaccines.

11:00 Safe medicines during pregnancy – Session 1 WHO HQ

 Perspectives and actions from WHO Dr Shanthi Pal
 Perspectives from Bangladesh healthcare
Bangladesh
professionals
Dr. Farhana Dewan

Dr Shanthi Pal informed the Assembly about the global actions from WHO to strengthen safety
surveillance of maternal and perinatal health, including the establishment of background rates of
adverse events of special interest to strengthen signal detection and assessment, and the
recommendations from ACSoMP on valproic acid. The participants noted the existence of resources in
the region which could be used to study and monitor the safety of medical products during
pregnancy.
Dr. Farhana Dewan shared her knowledge about the safety of medicines during pregnancy,
highlighting the specificities of this period and its challenges, and the shared responsibilities of all
actors to counsel patients with complete, accurate and current information on the risks and benefits
of medical products.

12:00 Antimicrobial resistance: experience from Bangladesh Bangladesh

Dr. Syed Ghulam Mogni
Mowla

Dr. Syed Ghulam Mogni Mowla highlighted the criticality of addressing antimicrobial resistance, the
complexity of the challenges, and the leading role of the government of Bangladesh in this global
fight.

12:15 Lunch Break

13:00 Coalition of interested Parties (CIP): update, support CIP members and All
provided, expectations and way forward participants

The secretariat provided an overview of the current status of the SEARN CIP. CIP members presented
to the Assembly the support provided during the 2023-2024 work plan. The Assembly expressed its

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gratitude for the support received, and considered that the support provided by the CIP and other
partners had been critical in making progress in the work plan. CIP members highlighted the
importance of strengthening the network and ensuring its sustainability, invited SEARN to continue
focusing on its core missions and the implementation of the strategies already developed, and to
carefully consider the opportunity of additional activities against the resources of the Network. It was
also noted that the development of the SEARN website may include information to facilitate contacts
between NRAs and partners.
CIP members and the Assembly welcomed the commitment from the Regional Director of WHO
SEARO to continue supporting SEARN as secretariat and developing a Quality Management System
(QMS) to formalize and institutionalize WHO SEARO support as a Secretariat, in consultation with
SEARN Members and to ensure continuity of support.
CIP members noted the draft 2024-2025 Workplan and the needs of the Network for technical
support through participation in drafting groups, as well as other foreseen needs, including financial
support for an in-country Good Storage and Distribution practices (GSDP) workshop programme and
mapping their own resources against the SEARN competency framework. CIP members will further
discuss these needs in their respective organizations and confirm the possible support.

14:30 Coffee Break

15:00 Feedback from the Steering Group Chair Steering Group

The Assembly was informed that since its last meeting in July 2023, there have been three meetings
of the Steering group, 15 Meetings of the 5 Working groups (three each), and 58 meetings of the 12
drafting groups. There were also one exceptional meeting on the minimum information required for
reliance and one optional information meeting on the SEARN Competency framework. Six surveys
have been finalised.

15:15 Participation of NRAs in SEARN SEARN Secretariat

The Assembly highlighted the importance of adequate representation of NRAs in the Network to
ensure it has the power to take decisions on the issues discussed in all SEARN Members. SEARN
Members noted that relevant authorities can participate in any relevant working groups and drafting
groups, and that the secretariat can facilitate invitation to other authorities when requested by a
Member. Informed by a survey and further discussions in the Steering group on 2 July 2024 and
during the Assembly, the Assembly agreed that the following NRAs should be invited in the following
meetings of the Assembly:
 Bhutan: National Medical Product Testing Laboratory (1 representative)
 India: Indian Pharmacopoeia Commission (1 representative), State/UT Drug Control
Authorities (2 representatives to be selected by the NRA)
 Sri Lanka: Medical Research Institute (vaccines department) (1 representative)
 Thailand: Department of Medical Sciences (1 representative)

In addition, the Assembly requested the SEARN secretariat to invite the relevant authorities to
nominate representatives towards establishing a working group 6 dedicated to traditional products.

15:30 Forum between SEARN and Industry SEARN Secretariat

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The Assembly agreed on the importance of consulting with stakeholders, and invited the Secretariat
to propose meetings on a case by case basis when the need arise.

15:45 SEARN Monitoring and evaluation framework SEARN Secretariat

The Assembly adopted the results of the 2023-2024 exercise and the proposed changes in the
Monitoring and evaluation framework. While some positive impact was observed, the Assembly
noted that more time and efforts are required to achieve the goals set by the strategies.

17:30 End of the meeting

4 July
Time Agenda item Lead
(Dhaka)
09:00 Safe medicines during pregnancy – Session 2 MEB Netherlands
 Perspectives from the EU (PRAC Chair)
 Discussion, proposals, and next steps in SEARN Dr Sabine Straus
WHO SEARO
Dr Adrien Inoubli

Dr Sabine Strauss presented perspectives and experience from the European Union regarding the
safety of medicines during pregnancy, covering EU Guidance Good Vigilance Practice regarding Risk
Management Plans and risk minimisation tools and Pregnancy Prevention Plans. The presentation
highlighted the aims of the different tools, examples, as well as the challenges in implementing these
and the importance of measuring impact.
Considering the SEARN strategies and workplan, as well as the contributions made during the sessions
dedicated to safe medicines during pregnancy, the Assembly recommended that SEARN:
 Develop a domain in its competency framework to support NRAs in ensuring safe medicines
during pregnancy (AP1)
 Pilot the regional mechanism for recommendations on risk management with valproate
(AP15)
 Include pregnancy adverse events in the priority list for monitoring /detection at the regional
level (AP16)

10:00 Work plan outputs Rapporteurs and WG

Chairs
Discussion and adoption of working groups’ outputs

WG1 Quality
The Assembly adopted the proposed outputs (AP8, AP9, AP14) presented by the Chair of the working
group, and agreed on the publication of public summaries, including:
 AP8: the highlights from the Regional hybrid workshop on the optimal use of reference
standards
 AP9: the template of a practical guide to testing in a country template
 AP14: the highlights from the 3 meetings and the recommendations to WHO, SEARN
Members and the Assembly.

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The Assembly noted the importance of the vision developed for regional collaboration and the
recommendations from the Regional hybrid workshop on the optimal use of reference standards
regarding Compliance with good practices and strengthening QMS, the optimal use of reference
standards, and the coordination with other initiatives beyond SEARN.
WG2 Regulatory Strengthening
The Assembly adopted the proposed outputs (AP1, AP5) presented by the Chair of the working group,
and agreed on the publication of public summaries, including:
 AP5: the minimum information required for reliance for medicines and vaccines and the
results of the mapping of SEARN reference NRAs (EMA)

The Assembly invited SEARN Members, partners and WHO to continue their efforts in developing and
implementing reliance.

WG3 Vigilance
The Assembly adopted the proposed outputs (AP15, AP16) presented by the Chair of the working
group, and agreed on the publication of public summaries, including:
 AP16: the list of priority medicines

WG4 Information Sharing

The Assembly adopted the proposed outputs (AP3, AP4, AP12) presented by the Chair of the working
group, and agreed on the publication of public summaries, including:
 AP3: the recommendations to the Assembly
The Assembly highlighted the importance of carefully considering the best means to establish MoUs
in the region to facilitate information sharing between SEARN Members.
WG5 Medical Devices
The Assembly adopted the proposed outputs (AP17, AP18) presented by the Chair of the working
group, and agreed on the publication of public summaries, including:
 AP17: the SEARN competency framework for medical devices
 AP18: the Possible criteria for selecting a Reference Regulatory Authority and the Minimum
information required for reliance for medical devices.

12:00 2024-2025 Workplan Chair Assembly

 Discussion and adoption of the 2024-2025 Workplan
 Discussion and adoption of the Nominations of
Rapporteurs and drafting group members

The Assembly adopted the proposed 2024-2025 Workplan, and amended and adopted the proposed
rapporteurs and drafting group members.

12:30 Other decisions Secretariat

 Proposed revised ToR, Discussion and Adoption
 Framework for SEARN secretariat on the publication of
SEARN outputs on the public website – Discussion and
Adoption
 Discussion and adoption of the Draft SEARN Quality Policy

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  Host of the next SEARN meeting – Discussion and
Adoption
 Rotation members of the Steering group – Discussion and
Adoption

Proposed revised ToR

The Assembly adopted the proposed updated terms of reference 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, with one clarification regarding propositions of
additional experts by the secretariat and further emphasis on the rule that only SEARN Members may
participation in the adoption of decisions.
Framework for SEARN secretariat on the publication of SEARN outputs on the public website
The Assembly adopted the Framework for SEARN secretariat on the publication of SEARN outputs on
the public website, pending further discussion at the Assembly, with one clarification in the
background regarding the needs of clarity from SEARN Members on what would be published on the
public website.
Discussion and adoption of the Draft SEARN Quality Policy
The Assembly adopted the Draft SEARN Quality Policy, with some corrections and further emphasis
on sustainability.
Host of the next SEARN meeting and rotation members of the Steering group
The Assembly welcomed the expression of interest from Bhutan and Nepal to host the next Assembly
meeting. The Assembly of the Members of SEARN agreed that Bhutan may host the meeting of the
Assembly in 2025, and that Nepal may host the meeting of the Assembly in 2026. As a consequence,
Bhutan replaced Bangladesh in the Steering group and, as host country, became its Chair.
Steering group meetings during the Assembly
The Assembly agreed that at the time of the meetings of the Assembly, the meetings of the Steering
group and the Assembly are combined, considering that the same representatives participate in both
meetings.

13:10 Summary of the decisions made Secretariat

The secretariat provided the Assembly with a summary of the main decisions made during this
meeting.

13:20 Conclusions of the meeting Chair Assembly

The meeting was concluded by Chair of the Assembly, who thanked the speakers and attendees for
their active participation in this meeting and congratulated the Assembly for having successfully
achieved all the objectives of the meeting. The Chair appreciated the efforts from all members of the
drafting groups, working groups, Steering group, Assembly and the secretariat over the past year,
welcomed the new work plan and congratulated Bhutan and Nepal as the hosts of the next meetings
of the Assembly. The secretariat, on behalf of the Members of SEARN, thanked the Government of
Bangladesh, and especially Ministry of Health and Family Welfare and the Directorate General of Drug
Administration (DGDA), as well as the WHO country office of Bangladesh for their support and the
successful organization of the meeting.

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