EMA Management Board: highlights of June 2023 meeting

9 June 2023

EMA’s Management Board met on 7-8 June in Amsterdam.

The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the EU regulatory framework fit for innovative medicines, support greater access to medicines for patients and better address major public health challenges of the future.

The Board was updated on EMA’s response to COVID-19. Following the end of the public health emergencies of international concern (PHEIC) being declared by WHO for COVID-19 and mpox in May 2023, some of the activities that EMA implemented during the pandemic are being rolled back to focus on preparedness for future crises. The COVID-19 business continuity plans for EMA and the European medicines regulatory network were also lifted on 10 May (see news announcement here).

The Board acknowledged the crucial role EMA and the European medicines regulatory network played during the pandemic and the transformation the Agency underwent during that period in terms of its regulatory responsibilities.

The Board also noted that EMA remains fully committed to supporting the EU response to the COVID-19 threat and ensuring the timely regulatory review of new or adapted vaccines and therapeutics. EMA’s Emergency Task Force will conclude ongoing COVID-19 related reviews and the composition of the group will be revised to ensure that it can respond swiftly and effectively to future pandemics, including provision of scientific advice. Rolling reviews for COVID-19 products will be discontinued, however some COVID-19 related procedures, such as vaccine strain updates, will still be accelerated.

EMA’s Medicine Shortages Steering Group, or MSSG, which was set up during the crisis to ensure a robust response to medicines supply in public health emergencies, will continue to monitor activities for shortage-related issues, although the forecasting of demand and supply of critical COVID-19 medicines will end.

Positive assessment of EMA activities in 2022

The Board assessed and adopted the Executive Director’s annual activity report for 2022. The annual activity report describes the implementation of the Agency’s work programme and the management and control systems in place. The Board recognised that although 2022 was another challenging year for EMA due to the COVID-19 pandemic, the Agency had managed to maintain the high quality of its core operations and to further develop, adapt and streamline its regulatory processes.

Other achievements highlighted by the Board include EMA’s activities in the global fight against antimicrobial resistance and its contributions to the EU’s Beating Cancer Plan. The report will be published on the EMA website shortly, together with the assessment by the Board.

Human medicines – achievements and challenges

Harald Enzmann, chair of EMA's Human Medicines Committee (CHMP), presented recent achievements and ongoing challenges in the area of human health. In particular, Dr Enzmann reflected on the work of the CHMP during the COVID-19 pandemic. “The pandemic put a great deal of stress on the entire medicines regulatory system, but overall was a success story for EMA, the CHMP and the system,” he said. “We faced unprecedented scientific and procedural challenges which we overcame with our three great successes - the scientific quality of our opinions, the speed of our procedures and professional communication, and were able to recommend approval for treatments and vaccines that played a crucial role in the global fight against COVID-19.”

Among the upcoming challenges and opportunities, the CHMP chair flagged artificial intelligence (AI), real-world data and real-world evidence as crucial tools that will be increasingly used in the regulatory landscape to support the development, authorisation and supervision of medicines in Europe.

Beating cancer

The Board was updated on EMA’s efforts to identify and enable the approval of cancer medicines with significant potential to transform patient care. In this regard, the Agency is exploring how it can apply lessons from the COVID-19 pandemic to the evaluation of these cancer medicines and use this as a ‘pathfinder’ to improve the evaluation of similarly transformative products in all therapeutic areas.

The Board was also updated on the Cancer Medicines Forum (CMF) by Dr Denis Lacombe, Director-General of the European Organisation for Research and Treatment of Cancer (EORTC) and the representative of doctors’ organisations at the Board.

Dr Lacombe, who co-chairs the forum with Dr Francesco Pignatti from EMA, presented the challenges of cancer medicines development internationally and how the forum is successfully providing a platform for academia to discuss and highlight the clinical needs for each disease. He also underlined the importance of building on existing frameworks for interaction, for example, with patients, health technology assessment bodies (HTAs), academia and international regulators.

The CMF was set up in March 2022 to help advance research into optimising cancer treatments and foster high standards in cancer care in the EU.

Clinical trials in the EU

EMA updated the Board on recent activities on clinical trials. The Accelerating Clinical Trials in the EU (ACT EU) initiative launched in March 2022, is a collaboration between the European Commission, the Heads of Medicines Agencies (HMA) and EMA that seeks to transform how clinical trials are initiated, designed and run in Europe. The Board received a report on the progress in the ACT EU focus areas for 2023.

Two important events were highlighted to the Board. On 9 June, a closed workshop on clinical trials in public health emergencies will be held and on 22-23 June, the first ACT EU workshop to establish a multi-stakeholder platform will take place. The workshop will propose a model for the new platform and advance discussions on priority topics identified by stakeholders.

The Board was also updated on the operational experience and recent improvements implemented in the Clinical Trials Information System (CTIS) under the EU Clinical Trials Regulation. The monthly number of submissions of clinical trials through CTIS continues to increase. The Board noted the launch of a public consultation to review the transparency rules for the publication of information on clinical trials submitted in the system. The Board also welcomed EMA’s efforts to engage stakeholders via public events and workshops planned in 2023 and to provide support to CTIS users via trainings, events and the publication of relevant materials.

Network data governance

The Board endorsed revised mandates of the two main data governance groups of the European medicines regulatory network - the Network Data Board (NDB) and the Big Data Steering Group (BDSG). These revisions resulted in minor amendments and aim to clarify the scope, division of responsibilities, composition, and stakeholder engagement model of both bodies.

The NDB proposes standards, accountabilities and responsibilities of data and their usage that ensure maximum value to the EU/EEA regulatory agencies is achieved. It is largely limited to the participation of EU Member States. The focus of the BDSG is the analysis of data such as real-world data and clinical trial raw data as well as advanced analytics including AI. The pharmaceutical industry will continue to participate in the discussions and exchanges of both groups via dedicated fora. The revised mandates of the NDB and the BDSG will be published shortly on EMA’s website.