Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions

EMAThe European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.

Users of the system, i.e. national competent authorities, marketing authorisation holders and sponsors of clinical trials, have to make final preparations to ensure that their processes and local IT infrastructure are compatible with the new system and the internationally agreed format.

An independent audit and a subsequent favourable recommendation from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the updated EudraVigilance system is fully functional. Therefore, pursuant to Article 24(2) third subparagraph of Regulation (EC) No 726/2004,(1) EMA's Management Board confirmed and announced that the EudraVigilance database has achieved full functionality and the system meets the functional specifications.

The enhancements for reporting and analysing suspected adverse reactions of the new EudraVigilance system will support better safety monitoring of medicines and a more efficient reporting process for stakeholders. Expected benefits include:

  • Simplified reporting of individual case safety reports (ICSRs) and the re-routing of ICSRs to Member States as marketing authorisation holders will no longer have to provide these reports to national competent authorities, but directly to EudraVigilance, which will ultimately reduce duplication of efforts. An ICSR provides information on an individual case of a suspected adverse reaction to a medicine;
  • Better detection of new or changing safety issues, enabling rapid action to protect public health;
  • Increased transparency based on broader access to reports of suspected adverse reactions by healthcare professionals and general public via the adrreports.euExternal link icon portal, the public interface of the EudraVigilance database;
  • Enhanced search and more efficient data analysis capabilities;
  • Increased system capacity and performance to support large volumes of users and reports (including non-serious adverse reactions originating from the EEA);
  • More efficient collaboration with the World Health Organization (WHO) as EMA will make the reports of individual cases of suspected adverse reactions within the EEA available to the WHO Uppsala Monitoring CentreExternal link icon (UMC) directly from EudraVigilance; Member States will no longer need to carry out this task.

The enhanced EudraVigilance system will be launched on 22 November 2017. Together with the launch, further legal obligations will become applicable to the mandatory electronic reporting through EudraVigilance as stated in the announcement of the EMA Management Board.

The reporting of adverse reactions by patients and healthcare professionals to national competent authorities based on local spontaneous reporting systems will remain unchanged. There will also be no changes to the reporting of suspected unexpected serious adverse reactions during clinical trials until the application of the new Clinical Trial Regulation.

The Agency will support national competent authorities, marketing authorisation holders and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face trainings, webinars and information days. Users can trial the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment as of 26 June 2017. Further information is available on the EudraVigilance training and support webpage.

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.

EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

EMA serves a market of over 500 million people living in the EU.

1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

Most Popular Now

AZD7442 PROVENT Phase III prophylaxis trial met pr…

Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the i...

Lilly and Lycia Therapeutics enter into strategic …

Eli Lilly and Company (NYSE: LLY) and Lycia Therapeutics, Inc. today announced a multi-year research collaboration and licensing agreement focused on the discovery, devel...

SK bioscience and GSK start Phase 3 trial of adjuv…

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination wit...

New study examines 'Achilles heel' of cancer tumou…

Researchers at the University of British Columbia's faculty of medicine and BC Cancer Research Institute have uncovered a weakness in a key enzyme that solid tumour cance...

AI algorithm solves structural biology challenges

Determining the 3D shapes of biological molecules is one of the hardest problems in modern biology and medical discovery. Companies and research institutions often spend ...

Blood vessels produce growth factor that promotes …

Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a dista...

A drug costing less than €2 a day helps in the tre…

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at th...

Can a heartburn drug help doctors treat COVID-19?

In the early days of the COVID-19 pandemic, doctors in Wuhan noticed something surprising. Many of the elderly patients who survived the virus were poor: not exactly the ...

Rheumatoid arthritis treated with implanted cells …

With a goal of developing rheumatoid arthritis therapies with minimal side effects, researchers at Washington University School of Medicine in St. Louis have genetically ...

No serious health effects linked to mRNA COVID-19 …

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 v...

Gut bacteria and flavonoid-rich foods are linked a…

Flavonoid-rich foods, including berries, apples, pears and wine, appear to have a positive effect on blood pressure levels, an association that is partially explained by ...

One in three Americans had COVID-19 by the end of …

A new study published in the journal Nature estimates that 103 million Americans, or 31 percent of the U.S. population, had been infected with SARS-CoV-2 by the end of 20...