Highlights of Management Board: June 2021 meeting

News 18/06/2021

The Management Board heard from EMA about recent developments in response to COVID-19. Since the last update in March, a fourth vaccine (Janssen vaccine) has been granted a conditional marketing authorisation, and a rolling review has started for the Sinovac vaccine, in addition to the ongoing rolling reviews for the Curevac, Novavax and Sputnik V vaccines. EMA continues to provide rapid scientific advice to developers of vaccines and therapeutics.

To address the increasing volume of COVID-19-related assessment procedures, the Agency has implemented additional short term measures to streamline activities in the European medicines regulatory network. The situation is being continuously monitored and measures will be amended as needed.

The Board has also initiated a reflection on lessons learnt from the COVID-19 pandemic. This topic will be discussed in further detail at the October Board meeting.

Positive assessment of EMA operations in 2020

The Board welcomed the publication of EMA’s Annual Report 2020 on 14 June, following written adoption of the report by the Board in April. The report highlights the key outcomes of the work that EMA and the network achieved last year, including the rapid response to COVID-19 and the core regulatory activities to protect public and animal health in the EU. Please refer to the news announcement for more information.

The activities described in the Annual Report formed the basis of the Executive Director’s annual activity report for 2020, which the Board assessed and adopted. The Board noted that although 2020 had been another challenging year for EMA due to the COVID-19 pandemic, the Agency had managed to maintain the high quality and continuity of its core operations whilst also completing the relocation to its permanent headquarters in Amsterdam. The Board also noted the Agency’s responsiveness in managing activities to address the pandemic and mitigating its impact on the supply of medicines in the EU as well as the significant efforts of EMA’s human medicines committee (CHMP) which led to the authorisation of the first COVID-19 vaccine before the end of 2020.

Other achievements highlighted by the Board include the Agency’s activities in the global fight against antimicrobial resistance as well as the publication of the Regulatory Science Strategy to 2025 and the European Medicines Agencies Network Strategy to 2025.

The Board also noted the concerns regarding the Agency’s staffing levels in light of its continuously increasing workload, the significant responsibilities assigned to the Agency over the last few years and the possible new tasks stemming from the European Commission proposal to extend EMA’s mandate.

The annual activity report describes the implementation of the Agency’s work programme and the management and control systems in place. The report assesses whether the Agency has carried out its activities in accordance with the principles of good governance. It will be published on the EMA website shortly together with the assessment by the Board.

Progress on EU IT systems required by the Clinical Trial Regulation

The Board welcomed the progress in the development and preparations for ‘go-live’ of the Clinical Trial Information System (CTIS). Following the independent audit reported in April 2021 and the endorsement on full functionality of CTIS by the Board, the publication of the Commission decision is anticipated for 31 July 2021 in the Official Journal of the European Union and go-live is currently on track for 31 January 2022.

The development of CTIS continues as planned and EMA, together with Member States and sponsor experts, are heavily engaged in working on the agreed functionalities for the go-live version of the system.

CTIS is a cornerstone to apply the principles of the Clinical Trial Regulation. Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring. It is now vitally important that stakeholder organisations, clinical trial sponsors and authorities, prepare their staff and processes to work with CTIS to make use of the strengths that the system and the legislation will bring to their activities. 

An extensive online training programme is available and Master Trainer programmes for Member States and sponsors are also ongoing. EMA will organise a public event on 29 July to provide information that will help sponsor organisations to prepare for CTIS.

Information management governance review

The Board heard a presentation on new ways of working for IT delivery. Following a review of existing governance and decision-making practices for the development of network IT services, the Agency intends to revise the role and responsibilities of decision-making boards including the Telematics governance. In parallel, EMA will increasingly adopt more ‘Agile’ ways of working to support the delivery of network IT services that enable the European medicines regulatory network to work effectively.

The Board endorsed a pilot project to test ways of ‘Agile’ working and gather lessons learned. The pilot will begin in summer 2021. As the pilot matures, it is expected that other projects will be transitioned into the new way of working during 2022. This activity supports the implementation of the European Medicines Agencies Network Strategy to 2025, which was endorsed by the Board in July 2020 and calls for improvements to the existing IT operating model and services in order to support digital strategy and digital business transformation within the European medicines regulatory network.

Update on IT security

The Board heard from EMA that the criminal intrusion of its IT systems at the end of 2020 was contained. Defensive cybersecurity capabilities are being enhanced with further investments to protect the Agency in the future. A revision of EMA’s information security strategy is also underway, with the aim of putting into place a three-year improvement road map in line with best practices for similar organisations.

Revised fees for veterinary medicines as of 28 January 2022

The Board adopted a revision to the ‘Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency’ (Implementing Rules) introducing new or amended fees and remuneration to national competent authorities for the updated procedures related to the revised veterinary legislation (Regulation (EU) 2019/6). The amendments will come into effect as of 28 January 2022, when the revised legislation is due to come into force. Further information will be published shortly.

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