Table of contents
- What’s new
- Supporting the development of medicines and vaccines
- Advice on clinical trials
- Monitoring the impact on medicine supply chains
- Advice on safety of medicines in COVID-19 patients
- Working with EU and international partners
- Impact on EMA activities and meetings
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.
What’s new
| 3 April 2020: EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used in compassionate use programmes across Europe when treating COVID-19 patients who are not eligible for inclusion in clinical trials. These recommendations aim to ensure a harmonised approach across EU Member States. They also explain which group of patients may benefit from treatment and provide preliminary information on the medicine’s safety. For more information, see:EMA provides recommendations on compassionate use of remdesivir for COVID-19 (03/04/2020)3 April 2020: EMA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) jointly chaired the second global regulatory workshop on Thursday 2 April under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The participants discussed the progress made in the development of potential COVID-19 treatments and reaffirmed the need for large clinical trials to generate conclusive evidence on which treatments work. ICMRA will publish a summary report of the meeting shortly. For more information, see:International regulators discuss available knowledge supporting COVID-19 medicine development (03/04/2020)1 April 2020: EMA advised patients and healthcare professionals to only use chloroquine and hydroxychloroquine medicines for their authorised indications or as part of clinical trials or national emergency use programmes for the treatment of COVID-19. This is to ensure patient safety and the best use of available supplies. For more information, see:COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (01/04/2020)31 March 2020: EMA announced that it has held discussions with developers of around 40 potential treatments and a dozen vaccines against COVID-19. No potential COVID-19 treatments had demonstrated efficacy based on the preliminary data available. EMA welcomes the launch of large clinical trials to test promising treatments and to generate conclusive evidence. Two vaccines had already entered phase I clinical trials. EMA estimated that it might take at least a year before a vaccine is ready for approval and available in sufficient quantities to enable widespread use. For more information, see:Update on treatments and vaccines against COVID-19 under development (31/03/2020)30 March 2020: EMA started issuing certificates that are signed and authenticated electronically in place of paper certificates. This applies to all ongoing and future requests for certificates during the COVID-19 pandemic. For more information, see:EMA to issue electronic certificates for medicines (30/03/2020)27 March 2020: EMA, the European Commission and the Heads of Medicines Agencies updated the Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic to cover safety reporting, the distribution of in-vitro diagnostics, medical devices and auditing. The updated guidance also incorporates changes in other sections, in particular on communicating with authorities, informed consent and the distribution of investigational medicines.27 March 2020: EMA advised patients and healthcare professionals that angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines) can continue to be used to treat high blood pressure, heart failure or kidney disease during the COVID-19 pandemic. There is currently no evidence from clinical or epidemiological studies that establishes a link between these medicines and worsening of COVID-19. Patients taking these medicines should not interrupt their treatment without speaking to their doctor or pharmacist first. EMA will keep its information on new COVID-19-related treatment recommendations up to date. For more information, see:EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic (27/03/2020) |
Older updates
| 27 March 2020: EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) encouraged all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register. They should also upload and make their study protocols public, with a description of the data collected or planned to be collected. This is to facilitate collaborations and speed up the design of observational studies by others. Researchers should include ‘COVID-19’ in the study title to allow easy retrieval of all COVID-19-related studies via the ‘Title of Study’ search filter.25 March 2020: EMA published guidance on the actions that sponsors of ongoing clinical trials affected by the COVID-19 pandemic should take to help ensure the integrity of their studies and the interpretation of study results while safeguarding the safety of trial participants as a first priority. This complements the good clinical practice guidance on how sponsors should adjust the management of clinical trials and participants during the pandemic. 24 March 2020: The International Coalition of Medicines Regulatory Authorities published a summary report of the first global regulatory workshop on COVID-19 vaccine development which was co-chaired by EMA. The report focuses on pre-clinical data requirements and the theoretical risk that vaccines against COVID-19 enhance the disease prior to starting first-in-human clinical trials. For more information, see:Global regulators map out data requirements for phase 1 COVID-19 vaccine trials (24/03/2020)First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development (18/03/2020)24 March 2020: Some Member States are experiencing medicine shortages due to an increased demand for some medicines. This is either because the medicines are used to treat COVID-19 patients or because patients are requesting more than their usual supplies. In order to prevent unnecessary strain on supply chains, patients should only receive their usual supply of medicines. For information on ongoing medicine shortages in the EU, patients and healthcare professionals can check the relevant national shortages registers and EMA’s shortages catalogue.24 March 2020: EMA urged patients to beware of potential falsified medicines sold by unregistered websites and vendors. These vendors may be exploiting fears during the COVID-19 pandemic and claiming that their products can prevent or cure COVID-19. They may also appear to provide easy access to medicines that are otherwise not readily available. Patients can stay safe when buying medicines online by following EU advice. For more information, see:COVID-19: Beware of falsified medicines from unregistered websites (24/03/2020)20 March 2020: The European Commission, EMA and the Head of Medicines Agencies provided guidance for sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic. It covers how to deal with the extraordinary situations the pandemic presents and includes specific advice on clinical trials for COVID-19 treatments. For more information, see:Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (20/03/2020)20 March 2020: EMA’s first Management Board meeting of 2020 took place virtually and was reduced to one and a half hours to allow EMA and the Member States to continue to focus resources on the response to the pandemic.19 March 2020: EMA’s Committee for Medicinal Products for Human Use (CHMP) urged the EU research community to prioritise large randomised controlled clinical studies as these are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments. They also emphasised the need to include all EU countries in these trials. EMA is currently engaging with stakeholders who can further support the conduct of clinical trials across Europe. For more information, see:Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments (19/03/2020)18 March 2020: The first global regulatory workshop on COVID-19 was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities. Co-chaired by EMA and the US Food and Drug Administration, it brought together delegates from 17 countries and experts from the World Health Organization and the European Commission to discuss the development of vaccines against COVID-19. For more information, see:First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development (18/03/2020)18 March 2020: There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID 19. However, EMA calls for further studies, which it is ready to support. Patients and healthcare professionals should consider all available options for treating coronavirus symptoms, including paracetamol and NSAIDs, in line with the product information and national guidelines. For more information, see: EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19 (18/03/2020)18 March 2020: EMA will participate as observer in the European Commission’s advisory panel on COVID-19. Chaired by Commission President Ursula von der Leyen and co-chaired by Stella Kyriakides, Commissioner for Health and Food Safety, the panel of European scientific experts will formulate EU guidelines for science-based and coordinated risk-management measures.17 March 2020: As of 16 March 2020, most EMA staff are working remotely. This is expected to last until the end of April 2020. 13 March 2020: EMA provides full fee waivers for scientific advice for potential vaccines and treatments for COVID-19. Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing 2019-ncov@ema.europa.eu. For more information, see:COVID-19: developers of medicines or vaccines to benefit from free scientific advice (13/03/2020)11 March 2020: Until the end of April 2020, EMA is holding all its committee and working party meetings virtually. Other EMA-hosted stakeholder events will either be held virtually or postponed until later in 2020. EMA has also initiated its business continuity plan for the effective management of the COVID-19 crisis. These measures do not impact EMA’s core activities. For more information, see:COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020 (11/03/2020)10 March 2020: The European medicines regulatory network has taken measures to monitor the potential impact of the outbreak of COVID-19 on human and veterinary medicine supply chains in the EU. This includes working with pharmaceutical industry associations, companies and manufacturers in the EU to assess the resilience of supply chains. For more information, see:Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU (10/03/2020)4 February 2020: EMA has activated its plan for managing emerging health threats. EMA encourages developers of potential vaccines or treatments for novel coronavirus disease (COVID-19) to make use of the Agency’s regulatory mechanisms to speed up development and approval and to contact EMA as soon as possible to discuss their strategy for evidence-generation, by emailing 2019-ncov@ema.europa.eu. For more information, see: EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19) (04/02/2020) |
Supporting the development of medicines and vaccines
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 2019-ncov@ema.europa.eu. 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:
Potential treatments and 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.
| Update: 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. |
Advice on clinical trials
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.
EMA, the European Commission and the Head of Medicines Agencies (HMA) developed the guidance and first published it on 20 March 2020.
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:
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:
In line with this guidance, EMA will be flexible and pragmatic during the assessment of affected clinical trial data submitted to the Agency as part of marketing authorisation applications.
EMA is currently engaging with stakeholders who can further support the conduct of COVID-19 clinical trials across Europe.
Monitoring the impact on medicine supply chains
Supply disruptions or medicine shortages can occur as a result of a temporary lockdown of manufacturing sites in areas affected by COVID-19, travel restrictions impacting exports or an increased demand.
Some Member States are experiencing shortages due to an increased demand for some medicines. This is either because the medicines are used to treat COVID-19 patients or because patients are requesting more than their usual supplies.
In order to prevent unnecessary strain on supply chains, patients should only receive their usual supply of medicines. Healthcare professionals should not write prescriptions that cover more than the usual duration.
For information on ongoing medicine shortages in the EU, patients and healthcare professionals can check the relevant national shortages registers and EMA’s shortages catalogue.
Pharmaceutical companies are putting in place measures for the continued supply of their medicines (for example, increasing stocks or finding an alternative source for products and materials).
They are also responsible for reporting (potential) medicines shortages to the relevant competent authorities.
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 has also started a review of manufacturing information on centrally authorised human and veterinary medicines to identify those most at risk. These will be 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.
The European medicines regulatory network is monitoring the potential impact of the coronavirus pandemic on the human and veterinary medicine supply chains in the EU closely.
The network has established the EU Executive Steering Group on Shortages of Medicines Caused by Major Events to address the impact of the pandemic on supply chains and to identify and coordinate EU-level measures for protecting patients.
This includes keeping patients and healthcare professionals informed about shortages and providing recommendations on mitigating actions.
The group is composed of representatives of EMA, the European Commission, the Heads of Medicines Agencies, the Coordination groups for Mutual-recognition and Decentralised Procedures for human and veterinary medicines (CMDh and CMDv) and risk communication specialists.
EMA and the national competent authorities share information on medicine shortages via the single point of contact network.
For more information on how EMA and the national competent authorities deal with and communicate on medicine shortages, see:
Advice on safety of medicines in COVID-19 patients
Update: 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.
Working with EU and international partners
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.
Impact on EMA activities and meetings
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 and provisionally until the end of April 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.
Related content
- Public health threats
- Scientific advice and protocol assistance
- How scientific advice works
- PRIME: priority medicines
- Accelerated assessment
- Conditional marketing authorisation
- Availability of medicines
- Clinical trials in human medicines
- Good clinical practice
- Buying medicines online
News and press releases
- EMA provides recommendations on compassionate use of remdesivir for COVID-19 (03/04/2020)
- International regulators discuss available knowledge supporting COVID-19 medicine development (03/04/2020)
- COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (01/04/2020)
- Update on treatments and vaccines against COVID-19 under development (31/03/2020)
- EMA to issue electronic certificates for medicines (30/03/2020)
- EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic (27/03/2020)
- Global regulators map out data requirements for phase 1 COVID-19 vaccine trials (24/03/2020)
- COVID-19: Beware of falsified medicines from unregistered websites (24/03/2020)
- Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (20/03/2020)
- EMA Management Board – highlights of March 2020 meeting (20/03/2020)
- Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments (19/03/2020)
- First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development (18/03/2020)
- EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19 (18/03/2020)
- COVID-19: developers of medicines or vaccines to benefit from free scientific advice (13/03/2020)
- COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020 (11/03/2020)
- Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU (10/03/2020)
- EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19) (04/02/2020)
External links
- WHO: Novel coronavirus
- ECDC: Novel coronavirus
- European Commission: Novel coronavirus
- European Commission: Horizon 2020: Funds for research on COVID-19 vaccine development, treatment and diagnostics
Source: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19#what’s-new-section
