Coronavirus disease (COVID-19)
The European Medicines Agency (EMA) contributes to the global response to the novel coronavirus outbreak. Under its plan for managing emerging health threats, EMA supports the development and approval of vaccines and treatments for novel coronavirus, together with other regulators in the European Union (EU) and worldwide.
The novel coronavirus (2019-nCoV) is a new strain of coronavirus that had not previously been identified in humans. The coronavirus family is known to cause illness in humans, from common cold to more severe or even fatal diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).
On 30 January 2020, The World Health Organization (WHO) declared the outbreak a public health emergency of international concern. On 11 March 2020, WHO characterised COVID-19 as a pandemic.
There are currently no authorised vaccines or treatments in the EU to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.
EMA has activated its plan for managing emerging health threats , which determines how EMA responds to and communicates on serious public health threats. For more information, see Public health threats.
Support for medicine developers
EMA encourages developers of potential vaccines or treatments for novel coronavirus infection to contact EMA as soon as possible to discuss their strategy for evidence-generation.
They should email their proposals to firstname.lastname@example.org. EMA will review the received proposals and will contact developers with the most relevant proposals for an initial discussion.
EMA has regulatory mechanisms to speed up development and approval, including:
- scientific advice;
- the PRIME scheme;
- the accelerated assessment and conditional marketing authorisation procedures.
Scientific advice is free of charge and can be fast-tracked for potential novel coronavirus treatments or vaccines:
EMA is analysing medicine development pipelines and supporting WHO's activities for the prioritisation and analysis of available evidence in order to map potential treatments and vaccines.
EMA is in contact with the developers of around 40 potential COVID-19 treatments.
No medicines have yet demonstrated efficacy in treating COVID-19, based on preliminary data presented to EMA.
EMA welcomes the launch of large clinical trials to test promising treatments and generate conclusive evidence on which of them work, in line the advice of its human medicines committee (CHMP).
Potential COVID-19 treatments currently undergoing clinical trials include:
- remdesivir (an investigational medicine);
- lopinavir/ritonavir (currently authorised as an anti-HIV medicine);
- chloroquine and hydroxychloroquine (currently authorised at national level as treatments against malaria and certain autoimmune diseases such as rheumatoid arthritis).
- systemic interferons, in particular interferon beta (currently authorised to treat diseases such as multiple sclerosis);
- monoclonal antibodies with activity against components of the immune system.
EMA is also in discussion with developers of a dozen potential COVID-19 vaccines. Two vaccines have already entered phase I clinical trials.
Vaccine development timelines are difficult to predict. Based on past experience, EMA estimates that it might take at least a year before a vaccine against COVID-19 is ready for approval and available in sufficient quantities to enable widespread use.
EMA will continue interacting with developers of potential treatments and vaccines to enable promising medicines to reach patients as soon as possible, initially in the clinical trial setting and eventually on the market.
Supporting the rapid development and approval of safe and effective COVID-19 treatments and vaccines is EMA’s top priority to help save lives during the pandemic.
Guidance is available for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic:
The guidance covers concrete changes and protocol deviations for dealing with extraordinary situations, such as the need for isolating participants, limited access to public spaces and the reallocation of healthcare professionals.
The guidance includes specific advice on clinical trials for COVID-19 treatments, including the need for large, multi-national trial protocols. This is line with the CHMP's call urging the EU research community to pritoritise such studies as they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments:
- CHMP statement: A call to pool EU research resources into large-scale, multi-centre, multi-arm clinical trials against COVID-19
Guidance is also available on the actions that sponsors of affacted clinical trials should take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority:
EMA is currently engaging with stakeholders who can further support the conduct of COVID-19 clinical trials across Europe.
Supply disruptions or medicine shortages could occur during the pandemic as a result of:
- temporary lockdowns of manufacturing sites;
- travel restrictions impacting exports;
- export bans;
- increased demand for medicines used to treat COVID-19 patients;
- stockpiling by hospitals, by individual citizens or at Member State level.
To provide strategic leadership for urgent and coordinated action to prevent and mitigate supply disruptions within the EU during the pandemic, the European medicines regulatory network has established the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.
The Group is composed of representatives of EMA, the European Commission, the Heads of Medicines Agencies (HMA), the Coordination groups for Mutual-recognition and Decentralised Procedures for human and veterinary medicines (CMDh and CMDv) and risk communication specialists. It is chaired by the European Commission.
Update: Some Member States have indicated that they are starting to experience shortages of certain medicines being used to treat COVID-19 patients or are expecting shortages to occur shortly. These medicines include medicines used in intensive care such as certain anaesthetics, antibiotics and muscle relaxants, and medicines used off-label for COVID-19.
The steering group, in cooperation with pharmaceutical companies, is in the process of setting up an enhanced fast-track monitoring system to help prevent and mitigate supply issues with these critical medicines.
Under this system, each pharmaceutical company is appointing a single contact point (industry single points of contact or i-SPOCs) who will report to EMA all ongoing or anticipated shortages of medicines used for treating COVID-19, irrespective of their authorisation route. This mechanism is similar to the single point of contact (SPOC) network that EMA and the national competent authorities already use to for exchange information on shortages.
Pharmaceutical companies should continue to report shortages to the national competent authorities concerned in parallel, in line with their existing obligations.
To avoid shortages due to stockpiling, some Member States are imposing restrictions on the quantities that can be prescribed to or purchased by citizens.
In addition, the steering group is developing guidance for companies on which regulatory rules could be applied with greater flexibility during the pandemic to help secure the supply of these critical medicines. This guidance will be made available on this website as soon as it has been finalised.
The European medicines regulatory network is continuously monitoring the impact of the pandemic on the human and veterinary medicine supply chains in the EU closely.
EMA and the national competent authorities are asking pharmaceutical industry associations, companies and manufacturers in the EU to carry out risk assessments and to inform regulators about the resilience of supply chains.
EMA is conducting a review of manufacturing information on centrally authorised human and veterinary medicines to identify those most at risk. These are a priority for discussions about remedial actions with the marketing authorisation holder. The CMDh and CMDv coordinate actions for nationally authorised medicines, working together with EMA.
Update: EMA is currently gathering information on shortages in hospital settings in Member States and is assessing the impact of India's export ban on some active substances.
Although most medicine shortages are normally dealt with at national level, during the COVID-19 pandemic EMA is acting as a central coordinator, supporting Member States' activities in preventing and mitigating supply disruptions.
For more information on how EMA and the national competent authorities deal with and communicate on medicine shortages, see:
EMA is aware of reports, particularly online, that some medicines could increase the risks of COVID-19. Research groups have been raising such hypotheses based on the current limited understanding of the biological mechanisms of the virus and comments or observations in individual patients.
EMA is continuously reviewing all available clinical evidence and is working with other regulatory and clinical bodies in providing reliable advice on the safe use of medicines during the COVID-19 pandemic. It will publish any new treatment recommendations as soon as available.
Advice is already available on:
- non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen;
- angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines).
At this stage, it is not possible to provide advice on the safety of many other medicines in patients with or at risk of COVID-19 infection.
This is because there are insufficient clinical or epidemiological data available and because understanding of the new virus and its interactions with the body’s natural defences is still incomplete. Observational data can be misleading, unless carefully collected and analysed.
When prescribing or administering medicines to COVID-19 patients, healthcare professionals should exercise their clinical judgement, taking into account:
- the medicine’s benefits and risks as described in its product information, including any warnings;
- any relevant guidance issued by EMA, WHO and the relevant national competent authorities;
- national treatment guidelines.
Patients already taking prescribed medicines should not interrupt their treatment, particularly if it is being used for the management of a chronic (long-term) condition. If patients have concerns, they should speak to their doctor or pharmacist.
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 outbreak 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 is taking steps to reduce the risk of the further spread of COVID-19.
Until the end of April 2020, it is hosting all committee and working party meetings virtually, and postponing or hosting stakeholder events virtually.
As of 16 March 2020, most EMA staff are working remotely.
This is 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 has initiated its business continuity plan to safeguard its core activities and to ring-fence resources to deal with COVID-19.
The Agency’s overarching goal is to expedite the development of effective measures to fight and prevent the spread of COVID-19 and to ensure that the assessment and monitoring of medicines are not disrupted so that patients in Europe continue to have access to high quality, safe and effective medicines during the pandemic.
EMA is continuously reviewing and adapting these measures as necessary.