13 March 2025
EMA/MB/45410/2025 - Adopted
Management Board
Agenda for the 127TH meeting of the Management Board
Held on 13 March 2025, Virtual (09:00 – 14:00)
Chair: Lorraine Nolan
Item Title MB action
1. Draft agenda For adoption,
EMA/MB/45410/2025*
2. Declarations of competing interests related to the current Oral report
agenda
3. Minutes from the 126th meeting, held on 11-12 December For information*,
2024, adopted by written procedure EMA/MB/580677/2024
4. Election of the Chair of the Management Board (in camera) By virtual ballot
A Points for automatic adoption/endorsement/agreement
A.1 Emergency Task Force (ETF) For information,
EMA/MB/54675/2025;
• Revised Rules of Procedure of Emergency Task Force (ETF) For agreement,
• Revised composition of the ETF for preparedness EMA/36439/2025*;
For adoption,
EMA/35247/2025*
B Points for discussion
B.1 Highlights of the Executive Director Oral report
B.2 Report from the European Commission Oral report
B.3 European Medicines Agencies Network Strategy to 2028 For information,
EMA/MB/76785/2025;
For adoption*,
EMA/376542/2024
B.4 EMA Annual Report 2024 For information,
EMA/MB/67605/2025;
For adoption,
EMA/38990/2025*
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© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.
Item Title MB action
B.5 Audit - Revised Global Internal Audit Standards: For information,
• Updated Internal Audit Charter EMA/MB/66687/2025;
• Updated Management Board’s decision establishing the For adoption,
Management Board Audits and Risks Group (MBARG) EMA/209787/2017,
EMA/MB/105013/2023
B.6 MB Decision of the EMA rules concerning the handling of For information,
declared interests of staff members and candidates before EMA/MB/59912/2025;
recruitment For adoption*,
EMA/MB/259494/2016
B.7 2024 EMA Annual Report on Independence For information,
EMA/MB/65819/2025;
For endorsement*,
EMA/573980/2024
B.8 2024 EMA Annual Report on the implementation of the EMA’s Oral Report
Anti-Fraud Strategy
B.9 African Medicines Agency Governing Board visit to EMA MB June For information,
EMA/MB/48720/2025,
EMA/592532/2024
B.10 Update on cybersecurity management at EMA Oral report
B.11 Clinical Trials in the EU For information,
• Update on CTIS and ACT-EU EMA/MB/64937/2025,
• Demo of CTIS Trial Map EMA/64938/2025
B.12 Network Data Steering Group update Oral report
C Points for information only**
C.1 Outcome of written procedures finalised during the period from For information*,
05 December 2024 to 04 March 2025 EMA/MB/587514/2024
C.2 2024 Annual Report on EudraVigilance for the European For information,
Parliament, the Council and the Commission Reporting period: 1 EMA/MB/48310/2025,
January to 31 December 2024 EMA/559856/2024*
C.3 Seventeenth six-monthly report on ex ante and retroactive For information,
evaluation of projects for the period 1 July to 31 December EMA/MB/29851/2025,
2024 EMA/29852/2025
C.4 Network Portfolio Report For information,
EMA/MB/54018/2025,
EMA/54023/2025
C.5 Summary of transfers of appropriations in budget 2024 For information,
EMA/MB/63669/2025
C.6 Annual Activity Report (AAR) 2024 For information,
EMA/MB/69904/2025,
EMA/69085/2025
C.7 ECA Annual report on EU agencies for the financial year 2023 For information
* Documents marked with a star * are intended for publication on the external website.
** Documents in Additional documents for information section are not intended for discussion unless specifically
requested.
Agenda for the 127TH meeting of the Management Board
EMA/MB/45410/2025 Page 2/2
