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 ringfence 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) is to help 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 acitivities 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's COVID-19 Task Force is to respond to the rapidly evolving scientific and regulatory challenges created by the pandemic and safeguard 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, Noel Wathion is chairing the Task Force.
A core group advising on policy and inter-institutional matters advises the Task Force. The role of this group is to ensure alignment with other EU and international partners at operational and political level, in close cooperation with the European Commission. It is led by EMA's Executive Director, Professor Guido Rasi.
The Task Force is supported by four cross-Agency work streams, providing advice to the Task Force on appropriate measures in high-priority areas.
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.
Update: The European medicines regulatory network's business continuity plan sets out the principles to ensure that 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. Member States must consider their resources and capacity when putting themselves forward to deal with such assessments on behalf of the EU.
It also sets out how non-COVID-19-related assessments are being carried out, and how Member States can deal with the inevitable disruptions arising from the pandemic. The plan aims to mitigate any delays to the evaluation and supervision of medicines as far as possible.
EMA, together with the European Commission and the Heads of Medicines Agencies (HMA), published the business continuity plan on 28 May 2020. They will review the plan on a regular basis and provide updates as necessary.
EMA works closely with other European bodies, 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 three video conferences per week to share information and expertise for the effective management of the COVID-19 crisis.
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.
EMA has taken steps to reduce the 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.
Until the end of September 2020, EMA is hosting all committee and working party meetings virtually. It is postponing stakeholder events, or holding them virtually.
As of 16 March 2020, most EMA staff are working remotely.
These measures are in line with the steps taken by the European Commission and the Dutch Government’s coronavirus containment efforts.
These measures do not impact EMA’s core activities related to the evaluation and supervision of medicines.
EMA is continuously reviewing and adapting these measures as necessary.