COVID-19: What's new

The latest updates on the COVID-19 pandemic from the European Medicines Agency (EMA), including all news and press releases, are available below.

Latest updates

DATETOPICUPDATEMORE INFORMATION 
9 JulyInternational Coalition of Medicines Regulatory Authorities (ICMRA)ICMRA published a report summarising its second workshop on the development of COVID-19 vaccines. The report highlights key considerations and data requirements for the design and conduct of phase 3 clinical trials.International regulators align positions on phase 3 COVID-19 vaccine trials (09/07/2020) 
6 JulyTreatments and vaccines for COVID-19The European Public Assessment Report (EPAR) for Veklury (remdesivir), including CHMP's assessment report, is available.Veklury 
6 JulyGuidance for medicine developers and companies on COVID-19EMA provided a template and dedicated email address for notifications of exceptional change management process (ECMP), as foreseen in the questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.  
3 JulyTreatments and vaccines for COVID-19The European Commission granted a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Veklury is the first treatment against COVID-19 in the EU.

European Commission authorises first treatment against COVID-19  (03/07/2020)

 
3 JulyTreatments and vaccines for COVID-19EMA has been in contact with the developers of:
  • 144 potential COVID-19 treatments;
  • 35 potential COVID-19 vaccines.
  
1 JulyInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA endorsed a joint statement on clinical trials from the International Coalition of Medicines Regulatory Authorities (ICMRA), which outlines the characteristics of COVID-19 trials most likely to generate conclusive evidence, and encourages adequate patient enrolment and public reporting of results.International regulators provide guiding principles for COVID-19 clinical trials (01/07/2020) 
1 JulyGuidance for medicine developers and companies on COVID-19EMA, the European Commission and the Heads of Medicine Agencies updated their questions and answers on regulatory expectations for medicinal products for  human use during the COVID-19 pandemic to cover pharmacovigilance inspections, system audits and the management of corrective and preventive actions (CAPAs).  
1 JulyGuidance for medicine developers and companies on COVID-19EMA, the European Commission and the Heads of Medicine Agencies updated their questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic to cover pharmacovigilance inspections.  
30 JuneEMA’s governance during COVID-19 pandemicEMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) signed an ad hoc confidentiality agreement to share confidential information and documents on COVID-19 and medicines intended for its diagnosis, prevention or treatment.EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information (30/06/2020) 
29 JuneEMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings virtually until the end of September 2020. Stakeholder events planned until the end of September will either be postponed or held virtually.  
29 JuneGuidance for medicine developers and companies on COVID-19EMA revised its guidance on  PDF iconImplications of COVID-19 on methodological aspects of ongoing clinical trials following a four-week public consultation.  
25 JuneTreatments and vaccines for COVID-19EMA's human medicines committee (CHMP) recommended for approval the first treatment against COVID-19 in the EU. CHMP gave a positive opinion for a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.First COVID-19 treatment recommended for EU authorisation  (25/06/2020) 
24 JuneInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA and the United States Food and Drug Administration (FDA) jointly chaired the second regulatory workshop on the development of COVID-19 vaccines on Monday 22 June, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed certain methodological aspects and data requirements for the design and conduct of phase 3 clinical trials.Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines (24/06/2020) 
24 JuneTreatments and vaccines for COVID-19EMA contracted IQVIA Ltd. on 8 June 2020 to carry out a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients.  
22 JuneTreatments and vaccines for COVID-19EMA and the United States Food and Drug Administration (FDA) shared their experiences and challenges in facilitating the development, review and availability of COVID-19 vaccines at their 2020 bilateral meeting, among other topics. They also discussed the use of real world evidence to support regulatory decisions.European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines (22/06/2020) 
16 JuneTreatments and vaccines for COVID-19EMA has been in contact with the developers of:
  • 132 potential COVID-19 treatments;
  • 34 potential COVID-19 vaccines.
  
15 JuneInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA participated in the fifth bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Friday, 12 June, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants focused on the planning, progress and prioritisation of COVID-19 clinical trials.Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4 (15/06/2020) 
15 JuneFees payable to the European Medicines AgencyEMA introduced a fee for its rolling review procedure. This fee is deductible from the fee EMA would charge for the marketing authorisation application once the company submits the full dossier following the rolling review. Micro, small and medium-sized enterprises (SMEs) are eligible for a 90% fee reduction for the rolling review. PDF iconRules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 12 June 2020  
10 JuneGood clinical practice (GCP) inspection proceduresEMA published PDF iconguidance on remote good-clinical-practice (GCP) inspections during the pandemic. This is the first in a series of guidance documents on remote inspections for the verification of compliance with EU and international standards during the pandemic.  
10 JuneTreatments and vaccines for COVID-19EMA extended its medical literature monitoring service to cover authorised active substances that could help treat COVID-19. EMA’s service aims to reduce duplication of effort and multiple reporting of suspected adverse events for active substances that have many marketing authorisation holders.Medical literature monitoring 
10 JunePublic-health advice during COVID-19 pandemicEMA reiterated its advice to patients and healthcare professionals that angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines) can continue to be used during the pandemic. This follows a review of recently published studies that showed no link between the use of these medicines and a higher risk of infection or worsening of COVID-19.Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic (10/06/2020) 
8 JuneAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. The steering group agreed that EMA would set up an ad hoc working group to improve the forecasting of future medicines demand in the EU, in preparation for a potential second wave of infections.EU actions to support availability of medicines during COVID-19 pandemic – update #7 (08/06/2020) 
8 JuneTreatments and vaccines for COVID-19EMA’s CHMP formally began evaluating remdesivir for a conditional marketing authorisation. The CHMP will assess this application under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. EMA also published its decision on the paediatric investigation plan (PIP) for remdesivir.EMA receives application for conditional authorisation of first COVID-19 treatment in the EU (08/06/2020) 
8 JuneGuidance for medicine developers and companies on COVID-19EMA published a visual guide on its fast-track procedures for COVID-19 treatments and vaccines.  
4 JuneEuropean Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meetingEMA updated patients’ and healthcare professionals’ organisations about its COVID-19-related activities at a virtual meeting with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party on Tuesday, 2 June 2020. A recording of the meeting is available.Patients’ and healthcare professionals’ organisations updated on EMA’s response to COVID-19  (04/05/2020) 
29 MayGuidance for medicine developers and companies on COVID-19EMA and the United States Food and Drug Administration published PDF iconjoint procedural assistance for medicine developers planning to submit a paediatric investigation plan (PIP) to EMA and an initial pediatric study plan (iPSP) to the FDA for a COVID-19 vaccine or treatment. The aim of the joint document is to make it easier for developers to submit paediatric development plans simultaneously to the regulators.  
29 MayInternational Coalition of Medicines Regulatory Authorities (ICMRA)The International Coalition of Medicines Regulatory Authorities (ICMRA) published a report summarising its global regulatory workshop on COVID-19 observational studies and the use of real-world data. The report provides an overview of global regulators’ priority areas for cooperation in the areas of pregnancy research, building international clinical cohorts, and preparing for vaccine safety and effectiveness monitoring.  
29 MayPublic-health advice during COVID-19 pandemicEMA reminded healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine. Several observational studies in COVID-19 have reported that chloroquine and hydroxychloroquine are associated with an increased risk of heart problems, a well-known side effect of such treatments, including cardiac arrhythmias and cardiac arrest.COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (29/05/2020) 
29 MayTreatments and vaccines for COVID-19EMA’s Executive Director sent an PDF iconopen letter to researchers from the Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, in response to their call for EMA to make the clinical data submitted as part of COVID-19-related evaluation procedures publicly available rapidly.  
29 MayTreatments and vaccines for COVID-19The rolling review of data on remdesivir concluded on 15 May 2020. The next step is for the company to submit an application for a conditional marketing authorisation, together with the additional data requested by EMA’s human medicines committee (CHMP). The CHMP will assess this application under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020(29/05/2020) 
28 MayInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA chaired the fourth bi-weekly strategic meeting on COVID-19-related policy approaches and regulatory flexibility on Wednesday 27 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed regulatory aspects of COVID-19 medicine development, pragmatic approaches to address challenges posed by the pandemic, and the mandate of the newly established ICMRA COVID-19 Working Group.Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3(28/05/2020) 
28 MayGuidance for medicine developers and companies on COVID-19EMA, the European Commission and the Heads of Medicine Agencies updated their guidance for pharmaceutical companies on adaptations to the regulatory framework to clarify the exceptional change-management process in place to reduce the risk of shortages or disruption of supply of crucial medicines for COVID-19. The update also introduces further temporary flexibility on good-manufacturing- and good-distribution-practice inspections and new guidance on inspections of plasma collection centres.  
28 MayEMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s closure on 1 June.Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020(28/05/2020) 
28 MayEMA’s governance during COVID-19 pandemicEMA, together with the European Commission and the Heads of Medicines Agencies (HMA), published their PDF iconbusiness continuity plan . This sets out principles to ensure that the European medicines regulatory network can continue to operate its core regulatory activities during the COVID-19 pandemic. It covers procedures related to medicines for COVID-19, as well as core procedures for other human and veterinary medicines.European medicines regulatory network fully mobilised in fight against COVID-19(28/05/2020) 
27 MayTreatments and vaccines for COVID-19EMA gave an update stating that it had been in contact with the developers of around:
  • 125 potential COVID-19 treatments;
  • 33 potential COVID-19 vaccines.
  
27 MayTreatments and vaccines for COVID-19EMA signed a contract with Utrecht University to conduct research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice once they are authorised in the EU. Under the ACCESS (vACcine Covid-19 monitoring readinESS) project, researchers will identify a Europe-wide network of data sources and possible adverse events requiring extra consideration.EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines(27/05/2020) 
26 MayGuidance for medicine developers and companies on COVID-19EMA encouraged collaboration between EU researchers on high-quality, multi-centre observational studies of COVID-19 treatments and vaccines. A new COVID-19 response group, set up by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), is in place to facilitate this collaboration. Recommendations on conducting high-quality observational research during the pandemic are also available in a recently published article by EMA staff and EU researchers.EMA calls for high-quality observational research in context of COVID-19(26/05/2020) 
20 MayInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA and Health Canada jointly chaired the fourth global regulatory workshop on Tuesday 19 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The participants identified priority areas for cooperation on observational research during COVID-19: pregnancy research, medicines used in clinical practice, and monitoring vaccine safety and effectiveness.Global regulators commit to cooperate on observational research in the context of COVID-19(20/05/2020) 
19 MayEMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings virtually until the end of August 2020. Stakeholder events planned until the end of August will either be postponed or held virtually.  
19 MayEMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s closure from 21 to 22 May.Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020(19/05/2020) 
18 MayEMA’s governance during COVID-19 pandemicEMA’s Executive Director, Guido Rasi, attended the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on Monday, 18 May, to respond to questions on EMA’s response to COVID-19. This followed his statement to the committee on Tuesday, 12 May. A recording of the session is available on the European Parliament’s website.  
18 MayInternational Coalition of Medicines Regulatory Authorities (ICMRA)
EMA participated in the third bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday 14 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed COVID-19 clinical-trial management, focusing in particular on the use of master protocols to help generate the robust evidence needed for regulatory decisions, and measures for mitigating medicine-supply issues.  
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2(18/05/2020) 
15 MayAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.EU actions to support availability of medicines during COVID-19 pandemic – update #6(15/05/2020) 
15 MayGuidance for medicine developers and companies on COVID-19Members of EMA staff and its scientific committees published an article setting out concrete actions that stakeholders involved in COVID-19 clinical trials should take in order to generate the conclusive evidence needed to enable rapid development and approval of potential treatments and vaccines against COVID-19. The article is available via open access on the website of Clinical Pharmacology & Therapeutics.International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials(15/05/2020) 
14 MayTreatments and vaccines for COVID-19EMA held a virtual press briefing explaining its efforts to expedite the development and approval of COVID-19 treatments and vaccines, its role in ensuring the continued availability of crucial medicines in the EU during the pandemic, and its publication of reliable information for patients and healthcare professionals. The press briefing featured Noël Wathion, EMA’s Deputy Executive Director, and Marco Cavaleri, EMA’s Head of Biological Health Threats and Vaccines Strategy. A recording of the briefing is available.  
14 MayFees payable to the European Medicines AgencyEMA announced that it is waiving its fees for on-site inspections of manufacturing sites and blood establishments that have been inspected remotely during the pandemic but where the remote inspection could not confirm compliance with good manufacturing practice (GMP) standards. For further details, see the
PDF icondecision of EMA’s Executive Director
  
14 MayTreatments and vaccines for COVID-19EMA gave an update stating that it had been in contact with the developers of around:
  • 115 potential COVID-19 treatments;
  • 33 potential COVID-19 vaccines.
  
13  MayEMA’s governance during COVID-19 pandemicEMA’s Executive Director, Guido Rasi, briefed the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on EMA’s response to COVID-19 on Tuesday, 12 May. He explained EMA’s efforts to expedite the development and approval of COVID-19 treatments and vaccines, its role in ensuring the continued availability of crucial medicines in the EU during the pandemic, and its publication of reliable information for patients and healthcare professionals. A recording of the session is available on the European Parliament’s website.  
11 MayTreatments and vaccines for COVID-19
EMA’s CHMP recommended extending the compassionate use of the investigational medicine remdesivir to further groups of patients in Europe, based on preliminary results of studies with the medicine. The updated recommendations cover hospitalised patients who are requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation), in addition to those on invasive mechanical ventilation. 
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation(11/05/2020) 
8 MayAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.EU actions to support availability of medicines during COVID-19 pandemic – update #5(08/05/2020) 
7 MayGuidance for medicine developers and companies on COVID-19EMA updated the eSubmission Gateway user interface to allow applicants to flag submissions related to COVID-19. The aim is to help EMA rapidly identify and prioritise COVID-19-related submissions. More information, including an updated user guide and release notes are available on the eSubmission website.  
5 MayInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA chaired the second bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday 30 April, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants focused on the development of medicines and vaccines development against COVID-19, and stressed the need for the alignment of regulatory requirements to help speed their development, evaluation and availability.Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19(05/05/2020) 
4 MayGuidance for medicine developers and companies on COVID-19EMA published PDF iconguidance for developers on the rapid review procedures it has put in place to speed up development and approval of COVID-19 treatments and vaccines. The rapid procedures can accelerate every step of the regulatory pathway while ensuring that robust evidence on efficacy, safety and quality is generated to support scientific and regulatory decisions. As these procedures require developers to submit well-prepared dossiers, EMA encourages them to contact the Agency as soon as possible to discuss their strategy for evidence-generation, by emailing their proposals to 2019-ncov@ema.europa.euCOVID-19: how EMA fast-tracks development support and approval of medicines and vaccines(04/05/2020) 
4 MayGuidance for medicine developers and companies on COVID-19EMA updated its guidance for marketing authorisation holders on how to submit COVID-19-related individual case safety reports (ICSR) to EudraVigilance. The update of the guidance follows the implementation of version 23.0 of the Medical Dictionary for Regulatory Activities (MedDRA) containing additional COVID-19-related terms in EudraVigilance on Monday, 4 May.   
4 MayGuidance for medicine developers and companies on COVID-19EMA, the European Commission and the national competent authorities published questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic. This guidance is for pharmaceutical companies responsible for veterinary medicines and sets out the adaptations to the regulatory framework in place to address challenges arising from the COVID-19 pandemic. It covers marketing authorisation procedures, pharmacovigilance and good-manufacturing-practice (GMP) certificates, and inspections for veterinary medicines. Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic (04/05/2020) 
30 AprilTreatments and vaccines for COVID-19EMA announced that its human medicines committee (CHMP) has started a rolling review of data on the use of the investigational antiviral medicine remdesivir for the treatment of COVID-19. This means that the CHMP is assessing data as they become available on a rolling basis while development is still ongoing. This is one of the Agency's regulatory tools to speed up the evaluation of a promising investigational treatment during a public health emergency.EMA starts rolling review of remdesivir for COVID-19(30/04/2020) 
30 AprilAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.EU actions to support availability of medicines during COVID-19 pandemic – update #4(30/04/2020) 
28 AprilGuidance for medicine developers and companies on COVID-19EMA, the European Commission and the Heads of Medicines Agencies updated the Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic. The updated guidance includes more recommendations on simple and flexible measures sponsors can take to manage clinical trials during the COVID-19 pandemic, given the impact it is having on European health systems and society in general.European Commission: Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU (28/04/2020) 
28 AprilInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA endorsed a joint statement by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA). The statement commits the international regulators to strengthen global collaboration to facilitate rapid development, approval and roll-out of safe and effective medicines against COVID-19.International regulators pledge collective support to combat COVID-19 pandemic(28/04/2020) 
24 AprilAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. This includes the development of guidance for pharmaceutical companies responsible for veterinary medicines on adaptations of the regulatory framework to address COVID-19-related challenges.EU actions to support availability of medicines during COVID-19 pandemic – update #3(24/04/2020) 
24 AprilPublic-health advice during COVID-19 pandemic
EMA and the national competent authorities reminded patients with suspected or confirmed COVID-19 to report any suspected side effects that they are experiencing with any medicine, including medicines taken to treat COVID-19 and pre-existing conditions. Healthcare professionals treating COVID-19 patients should also report the suspected side effects that their patients are experiencing. These reports help regulators understand how medicines act in patients with COVID-19, complementing the knowledge generated in clinical trials and other studies.
Reporting suspected side effects of medicines in patients with COVID-19(24/04/2020) 
23 AprilEMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s closure on 27 April and on 1 May 2020.Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27 April and on 1 May 2020(23/04/2020) 
23 AprilPublic-health advice during COVID-19 pandemicEMA reminded patients and healthcare professionals that chloroquine and hydroxychloroquine medicines are known to potentially cause certain side effects, including heart rhythm problems. Healthcare professionals should carefully consider the possibility of heart rhythm problems when treating COVID-19 patients with these medicines, particularly in patients with pre-existing heart problems and with higher doses, and exercise extra caution when combining treatment with other medicines such as azithromycin that have similar effects on the heart.COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine(23/04/2020) 
21 AprilInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA participated in the global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday, 16 April, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed high-level policy issues and regulatory challenges related to the rapid development of potential COVID-19 treatments and vaccines and the continued availability of medicines during the pandemic, in particular those used in intensive care. The meeting was the first of a series of bi-weekly meetings organised by ICMRA to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and avoiding medicine shortages. EMA will chair every other meeting.  
21 AprilAvailability of medicines during COVID-19 pandemicEMA announced that it had launched, together with EU Member States and the pharmaceutical industry, an enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial medicines used for treating COVID-19 patients. Initially, the system will focus on medicines used in intensive care, which are in greatest demand, before extending to a broader range of medicines. The monitoring system, which involves each pharmaceutical company appointing an industry single point of contact (iSPOC), was set up by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events in cooperation with pharmaceutical companies in the EU.Launch of enhanced monitoring system for availability of medicines used for treating COVID-19(21/04/2020) 
21 AprilEMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings virtually until the end of May 2020. Stakeholder events planned for May will either be postponed or held virtually. Most EMA staff are also continuing to work remotely until the end of May.  
20 AprilGuidance for medicine developers and companies on COVID-19The European Commission, EMA and the Heads of Medicine Agencies updated their guidance for pharmaceutical companies on adaptations to the regulatory framework to address COVID-19 challenges to cover good manufacturing practice (GMP) and good distribution practice (GDP) inspections, and the submission of individual case safety reports (ICSRs) to EudraVigilance. EMA published PDF iconadditional guidance for qualified persons for pharmcovigilance (QPPV) and marketing authorisation holders on how to submit COVID-19-related ICSRs to EudraVigilance, including on the use of the correct Medical Dictionary for Regulatory Activities (MedDRA) terms and free-text fields.Update to guidance on regulatory expectations in the context of COVID-19 pandemic(20/04/2020) 
20 AprilAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. The update covers progress made in setting up an enhanced monitoring system for supply issues with crucial medicines for the treatment of COVID-19 and planned updates to the guidance for pharmaceutical companies on adaptations of the regulatory framework to address COVID-19-related challenges.EU actions to support availability of medicines during COVID-19 pandemic – update #2(20/04/2020) 
16 AprilInternational Coalition of Medicines Regulatory Authorities (ICMRA)The International Coalition of Medicines Regulatory Authorities published a report summarising the third global regulatory workshop on the use of observational studies and real-world data in generating robust evidence on the safety and efficacy of COVID-19 vaccines and treatments. The report provides a snapshot of ongoing and planned observational studies, platforms and registries in various countries and regions around the world. EMA co-chaired the meeting with Health Canada.Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data(16/04/2020) 
10 AprilAvailability of medicines during COVID-19 pandemicEMA, the European Commission and the European medicines regulatory network published guidance for companies on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.Guidance on regulatory requirements in the context of the COVID-19 pandemic(10/04/2020) 
10 AprilAvailability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting place to support the continued availability of medicines during the pandemic. This covers the enhanced monitoring system for supply issues with crucial medicines for the treatment of COVID-19 and the guidance currently under development on the regulatory rules that could be applied with greater flexibility to help secure their continued supply.Update on EU actions to support availability of medicines during COVID-19 pandemic(10/04/2020)  
9 AprilEMA’s governance during COVID-19 pandemicEMA published the PDF iconmandate of its COVID-19 EMA pandemic Task Force (COVID-ETF).  The Task Force is helping 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.EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines(09/04/2020)   
9 AprilInternational Coalition of Medicines Regulatory Authorities (ICMRA)The International Coalition of Medicines Regulatory Authorities published the report summarising the second global regulatory workshop on COVID-19 medicine development held on Thursday 2 April. The report stresses the need for robust evidence to show which potential treatments work. EMA co-chaired the meeting.Global regulators stress need for robust evidence on COVID-19 treatments(09/04/2020) 
7 AprilInternational Coalition of Medicines Regulatory Authorities (ICMRA)EMA and Health Canada jointly chaired the third global regulatory workshop on Monday 6 April under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The participants discussed how data generated during clinical practice in the treatment of COVID-19 could complement evidence from clinical trials of potential COVID-19 treatments and vaccines.Global regulators discuss observational studies of real world data for COVID-19 medicines(07/04/2020) 
7 AprilEMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s Easter break from 9 to 13 April 2020.Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020(07/04/2020) 
6 AprilAvailability of medicines during COVID-19 pandemicEMA announced new EU-level measures to help prevent and mitigate supply issues with medicines used to treat COVID-19 patients. These include enhanced coordination with the pharmaceutical industry in monitoring supply issues and regulatory actions to support companies in increasing the available supply of critical medicines. During this extraordinary health crisis, EMA will act as the central EU coordinator, supporting Member States' activities in preventing and mitigating supply issues.EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic(06/04/2020) 
3 AprilTreatments and vaccines for COVID-19EMA’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.EMA provides recommendations on compassionate use of remdesivir for COVID-19(03/04/2020) 
3 AprilInternational Coalition of Medicines Regulatory Authorities (ICMRA)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.International regulators discuss available knowledge supporting COVID-19 medicine development (03/04/2020) 
1 AprilPublic-health advice during COVID-19 pandemicEMA 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.COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes(01/04/2020) 
31 MatchTreatments and vaccines for COVID-19EMA 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. Update on treatments and vaccines against COVID-19 under development (31/03/2020) 
30 MarchCertification of medicinal productsEMA 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.EMA to issue electronic certificates for medicines(30/03/2020) 
27 MarchGuidance for medicine developers and companies on COVID-19EMA, 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 MarchPublic-health advice during COVID-19 pandemicEMA 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.EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic(27/03/2020) 
27 MarchTreatments and vaccines for COVID-19EMA 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 MarchGuidance for medicine developers and companies on COVID-19EMA 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 MarchInternational Coalition of Medicines Regulatory Authorities (ICMRA)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.Global regulators map out data requirements for phase 1 COVID-19 vaccine trials(14/03/22020) 
24 MarchAvailability of medicines during COVID-19 pandemicSome 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 MarchBuying medicines onlineEMA 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 adviceCOVID-19: Beware of falsified medicines from unregistered websites(24/03/2020) 
20 MarchGuidance for medicine developers and companies on COVID-19The 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.Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic(20/03/2020) 
20 MarchEMA’s governance during COVID-19 pandemicEMA’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.EMA Management Board – highlights of March 2020 meeting(20/03/2020) 
19 MarchGuidance for medicine developers and companies on COVID-19EMA'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.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 MarchInternational Coalition of Medicines Regulatory Authorities (ICMRA)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. First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development(18/03/2020) 
18 MarchPublic-health advice during COVID-19 pandemicEMA advised patients and healthcare professionals that there 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.EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19(18/03/2020) 
18 MarchEMA’s governance during COVID-19 pandemicEMA announced that it 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 MarchEMA’s governance during COVID-19 pandemicAs of 16 March 2020, most EMA staff are working remotely. This is expected to last until the end of April 2020.   
13 MarchGuidance for medicine developers and companies on COVID-19EMA 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.euCOVID-19: developers of medicines or vaccines to benefit from free scientific advice(13/03/2020) 
11 MarchEMA’s governance during COVID-19 pandemicEMA announced that is holding all its committee and working party meetings virtually until the end of April 2020. 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.COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020(11/03/2020) 
10 MarchAvailability of medicines during COVID-19 pandemicThe 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.Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU(10/03/2020) 
4 FebruaryGuidance for medicine developers and companies on COVID-19EMA encouraged 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. EMA has activated its plan for managing emerging health threats.EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19) (04/02/2020) 

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