At its 16 June 2022 meeting in Amsterdam, the European Medicines Agency’s (EMA) Management Board elected Christelle Ratignier-Carbonneil as vice-Chair of the Board for a three-year period. Christelle Ratignier-Carbonneil replaces Lorraine Nolan, who was elected as Management Board Chair at its March 2022 meeting.
The Chair also welcomed three new civil society representatives – Virginie Hivert [link to CV], Denis Lacombe, Despoina Iatridou [link to CV]- as well as Karin Kadenbach as new representative from the European Parliament (EP) to the Board. Marco Grecowas congratulated on his re-appointment as representative of patients’ organisations and Anthony Borg as EP representative.
EMA updated the Board about the efforts made by the Agency in monitoring the impact of the war in Ukraine on the supply of medicines in the European Union (EU) and the situation deriving from the international outbreak of Monkeypox.
COVID-19
The Board heard an update on the COVID-19 products authorised since the last meeting in March. EMA reported on the current efforts to adapt the composition of the authorised COVID-19 mRNA vaccines to target Omicron variants in time for the vaccination campaigns this autumn. The first results from clinical trials are expected to become available very soon. Manufacturers are already preparing their applications for adapted vaccines. Initial packages of data have been submitted for rolling review by Biontech/Pfizer and Moderna.
EMA extended mandate
The Board heard an update about the implementation of the new EU regulation that reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. The newly established Medicines Shortages Steering Group (MSSG) had its first meeting on 11 May and is now fully operational. It has been put in place to mitigate and respond to medicine supply issues caused by major events or public health emergencies. The Emergency Task Force (ETF) , which was originally convened in March 2020 to specifically address the COVID-19 pandemic, started operating under the new rules in mid-April. The Board adopted the rules of procedure via written procedure of both entities in April.
Annual Activity Report 2021
The Board adopted the 2021 Annual Activity Report (AAR). The Board commended the achievements of the Agency, recognising that EMA has continued to fulfil its mission to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public and animal health: 92 human medicines and 12 veterinary medicines were recommended for marketing authorisation in the EU in 2021. The Board also recognised EMA’s resilience and determination to successfully support global efforts to combat the COVID-19 pandemic and acknowledged the substantial efforts made in the area of communication to provide the public with factual, up-to-date information during the crisis. The document will be published on the EMA website shortly.
Task Force on Availability of Medicines
The new composition of the Task Force on Availability of Medicines (TFAAM) was adopted by the Board. The TFAAM was set up by EMA and the Heads of Medicines Agencies (HMA) in 2016 to provide strategic support, advice for coordination and concerted approach to the Network on the availability of human and veterinary medicinal products authorised in the EU. A revised work programme and an extension of the mandate of the task force for three more years were also adopted by the Board.
Clinical Trials in the EU
EMA gave an update on recent activities on clinical trials in the EU. The Board stressed the importance of the communication efforts needed to make sponsors prepare for the approaching deadline of 31 January 2023. As of that date all applications for new trials must go directly through the Clinical Trials Information System (CTIS). EMA continues to provide support to CTIS users by updating online training materials and providing live training and support sessions. The Board was also updated on the progress of the joint EC/HMA/EMA initiative to Accelerate Clinical Trials in the EU (ACT EU). One of the first deliverables from the initiative is the publication of a set of Key Performance Indicators (KPIs) that enable monitoring the clinical trials environment in the EU, published for the first time on International Clinical Trials Day on 20 May. The KPIs will be updated monthly on the EMA website pulling information from the two existing EU clinical trials databases: EudraCT and CTIS. Another outcome from ACT EU is the publication of a guidance document on 2 June, with key considerations for the planning and conduct of complex clinical trials.
Big Data Steering Group
The Board received a progress report on the implementation of the Big Data Steering Group (BDSG) workplan. The report highlighted first ever publication of an EU list of metadata which will support the findability of real-world data sources for medicines regulation. The Board was informed of the finalisation of the European Medicines Regulatory Network’s Clusters of Excellence discussion paper that aims to embed data analytics in the daily work or medicines regulators, of preparations for the launch of the planned clinical trial raw data pilot, which will run to 2024, and the ongoing process to review the BDSG workplan. An update on DARWIN EU included progress with pilots with the EMA committees was presented and the Board noted that in the coming months the first DARWIN EU data partners will be on-boarded and pilot studies launched.
Implementation of the Veterinary Medicinal Products Regulation
The Board noted the continued efforts and collaboration between national competent authorities and EMA to finalise the upload of product data into the Union Product Database. Since the launch of the IT systems for the Veterinary Medicinal Products Regulation, national regulators and EMA have continued to complete the information on products authorised before 28 January 2022. The Board also welcomed the adoption of the European Veterinary Big Data strategy to 2027 by HMA and EMA. It outlines a vision for fostering data-driven, digital innovations in veterinary medicines in the EU, building on the Veterinary Regulation.
Information Management update
The Board heard an update on the ‘Agile’ transformation of the IT portfolio of EMA and the European medicines regulatory network. EMA expects the transition to the ‘Agile way of working’ to be complete by 2023. The new portfolio report on the status and progress of the Network portfolio was presented. The document includes updates on the recently formed ‘Agile Value Streams’ and the status of on-going programmes, projects and IT operations. The Board welcomed the Technology Capability Investment Plan (TCIP) for 2022-2025 that provides direction for human and financial resource investment for the delivery and application of EMA’s technology capabilities. The purpose of the plan is to provide insight into how EMA envisions a more interoperable and connected Network with further streamlining of interactions between the Agency and the Network.
EMA Working Parties
The Board noted the status of the implementation plan of the new operational model of the working parties of EMA. The Agency gave a presentation on the activities of the first phase. The membership of the working parties in three human domains (non-clinical, methodology and clinical) has been re-organised based on expertise. Chairs and vice-Chairs have also been elected. A pilot was launched for the new pilar in the working party model, the European Specialised Expert Community, which aims to bring together a community of experts with special knowledge in a given scientific/medical area that contribute to the European Regulatory Network. The Board was also informed on the roadmap of the implementation plan and the next steps that are expected.
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