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.
Update: The Emergency Task Force (ETF) is handling regulatory activities during the ongoing COVID-19 pandemic.
The ETF is an advisory and support body that handles regulatory activities in preparation for and during public-health emergencies. The ETF took over the activities of the former COVID-19 EMA Pandemic Task Force in March 2022.
EMA established the ETF in line with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). This Regulation made the Task Force permanent and entrusted it with an important role in crisis preparedness.
For full details on the ETF’s role, responsibilities and composition, see:
EMA convened the COVID-19 EMA Pandemic Task Force in March 2020 to address the COVID-19 pandemic.
The Task Force was in operation until the establishment of the ETF in March 2022.
Information on this former Task Force is available for reference purposes in this document:
EMA’s COVID-19 Steering Group provides strategic oversight at EMA of the evolving scientific and regulatory challenges created by COVID-19, and other topics and emerging issues of importance, including from a political, interinstitutional or international perspective.
It also monitors the response to COVID-19 by EMA and the European medicines regulatory network, maintains and adapts EMA’s COVID-19 business continuity plan and oversees review and reporting on lessons learned from the pandemic.
The Steering group is composed of senior EMA staff. Melanie Carr, Head of Stakeholders and Communication Division and responsible for Crisis Management, chairs the Steering Group since July 2021.
The Steering Group was formerly known as the EMA COVID-19 Task Force.
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.
Additional temporary measures
In addition to the arrangements described in the document above, EMA introduced further temporary measures in May 2021 to allow the network to focus its resources on COVID-19-related assessments.
These will remain in place until further notice.
EMA is keeping the measures under review and will amend them if necessary.
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 has been holding meetings virtually for its scientific committees, working parties and stakeholders. EMA staff have mainly been working remotely.
EMA continues to monitor the pandemic situation in the Netherlands and in the EU, adapting its measures as necessary.
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.