EMA’s governance during COVID-19 pandemic
The European Medicines Agency (EMA) has established dedicated task forces to deal with the scientific, regulatory and operational challenges created by the COVID-19 pandemic and initiated its business continuity plan. The aim of these measures is to safeguard the Agency's core activities related to the evaluation and supervision of medicines during the pandemic and to ring-fence resources dealing with COVID-19.
EMA aims to expedite the development of effective measures to fight and prevent the spread of COVID-19. This includes exploring ways for accelerating the development of COVID-19 vaccines and treatments, in close cooperation with the European medicines regulatory network.
EMA is also working to ensure that the assessment and monitoring of medicines are not disrupted, so that patients in Europe can continue to have access to high quality, safe and effective medicines during the pandemic.
The role of the COVID-19 EMA pandemic Task Force (COVID-ETF), chaired by Marco Cavaleri, head of the office Anti-infectives and Vaccines, is to help European Union (EU) Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19.
The activities of the Task Force include:
- reviewing available scientific data on potential COVID-19 medicines and identifying promising candidates;
- requesting data from developers and engaging with them in preliminary discussions;
- offering scientific support in collaboration with the clinical trials facilitation group (CTFG) to facilitate clinical trials conducted in the EU for the most promising medicines for COVID-19;
- providing feedback on development plans of COVID-19 medicines when formal rapid scientific advice is not feasible;
- advising the Scientific Advice Working Party (SAWP) or the CHMP on formal scientific advice and product-related assessments;
- contributing to the activities of the Pharmacovigilance Risk Assessment Committee (PRAC) on emerging safety issues related to COVID-19;
- ensuring close cooperation with stakeholders and relevant European and international organisations.
The Task Force is accountable to EMA’s CHMP for all its activities.
For more information on the composition and activities of the Task Force, see:
The role of the EMA COVID-19 Steering Group is to respond to the rapidly evolving scientific and regulatory challenges created by the pandemic. It also safeguards the continuity of the Agency’s activities by continuously adapting the Agency’s COVID-19 business continuity plan as needed.
EMA's Deputy Executive Director, Noël Wathion, chairs the Steering Group.
The Steering Group was called the EMA COVID-19 Task Force until October 2020. Its role remains unchanged.
A core group led by EMA's Executive Director advises the Steering Group on policy and inter-institutional matters. The role of the core group is to ensure alignment with other EU and international partners at operational and political levels, in close cooperation with the European Commission.
The Steering Group is supported by four cross-Agency work streams. These provide advice on appropriate measures in the four high-priority areas listed below.
Overview of work streams
EMA's health threats plan describes how EMA responds to serious public health threats, such as the COVID-19 pandemic.
It sets out the roles and responsibilities of its scientific committees and staff and describes EMA's communication with EU Member States, international partners, stakeholders and the public.
It also covers operational aspects such as providing rapid scientific advice for products under development and fast-track approval of medicines such as vaccines and antivirals.
EMA activated its health threats plan in early 2020 in response to the COVID-19 outbreak.
The European medicines regulatory network's business continuity plan sets out the principles to ensure that EMA, the EU Member States and the European Commission continue to operate their core regulatory activities to protect public and animal health in the EU during the COVID-19 pandemic.
It covers procedures related to medicines for COVID-19, as well as core procedures forall other human and veterinary medicines, irrespective of their authorisation route:
The plan makes it clear that the assessment of COVID-19 treatments and vaccines cannot be delayed under any circumstances.
It also sets out how to handle possible delays for non-COVID-19-related assessments, and how Member States can deal with the inevitable disruptions arising from the pandemic. The plan aims to mitigate as much as possible potential delays to the evaluation and supervision of medicines.
EMA works closely with other European partners, including the European Commission, the Health Security Committee and the European Centre for Disease Prevention and Control (ECDC), and with international partners such as the WHO and regulators from affected countries.
ECDC and WHO are producing a series of risk assessments, epidemiological updates and other information:
EU authorities are monitoring the pandemic closely and are providing updates as information becomes available.
As of March 2020, the European Commission's Directorate-General for Health and Food Safety, ECDC and EMA have been holding weekly video conferences to share information and coordinate activities for the effective management of the COVID-19 crisis.
For more information on how EMA is supporting the EU response to the COVID-19 pandemic, see:
Medicine regulatory authorities worldwide are cooperating under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) with the aim of expediting and streamlining the development of COVID-19 vaccines and treatments. For more information, see ICMRA: Supporting the development of COVID-19 vaccines and treatments.
The OPEN Initiative allows WHO and medicines regulators from outside the EU to take part in EMA's scientific evaluations.
The initiative aims to:
- facilitate sharing of scientific expertise;
- tackle common challenges,
- enhance transparency on regulatory decisions.
The pilot began in December 2020 and runs until the COVID-19 pandemic ends. Regulators from Australia, Canada, Japan and Switzerland are taking part. They work in line with their confidentiality arrangements with EMA and keep their scientific and regulatory independence in full. EMA will publish a report after the end of the pilot.
For more information on the OPEN Initiative, the pilot and its participants, see:
EMA has taken steps to reduce further spread of COVID-19, with the aim of protecting staff, delegates and experts and playing our part as responsible citizens in our host country, the Netherlands.
EMA continuously reviews and adapts its measures as necessary.
As of 16 March 2020, most EMA staff are working remotely.
EMA is continuing to hold meetings virtually for its scientific committees, working parties and stakeholders, until further notice. Speakers at a small number of stakeholder events may be attending in person.
EMA's measures align with the steps taken by the European Commission and the Dutch Government’s coronavirus containment efforts. They do not impact on EMA’s core activities related to the evaluation and supervision of medicines.