On 22nd November 2017, the European Medicines Agency (EMA) launched 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).
To support stronger safety monitoring of medicines the new system has enhanced features for the reporting and analysis of suspected adverse reactions. The new system makes it easier for marketing authorisation holders and sponsors of clinical trials to report suspected adverse reactions. The aim is improved safety monitoring for patients across Europe.
Expected benefits of the new EudraVigilance system:
- “Simplified reporting of individual case safety reports (ICSR) and reduced duplication of efforts, as marketing authorisation holders no longer have to provide these reports to national competent authorities, but can send them directly to EudraVigilance;
- better detection of new or changing safety issues, enabling rapid action by regulators to protect public health;
- enhanced interoperability based on the use of the ISO/ICH agreed standard for individual case safety reports;
- better searching ability and more efficient data analysis;
- increased system capacity to support large volumes of users and reports;
- 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 Centre (UMC) directly from EudraVigilance; Member States will no longer need to carry out this task.”
As stated in the EMA Management Board announcement published in May, with this launch further legal requirements will become applicable to the compulsory electronic reporting through EudraVigilance.
There will be no changes to:
- The reporting of adverse reactions by patients and healthcare professionals to national competent authorities based on local spontaneous reporting systems.
- The reporting of suspected unexpected serious adverse reactions (SUSARs) during clinical trials until the application of the new Clinical Trial Regulation.
The EMA will continue to support stakeholders through targeted e-learning and face-to-face training, webinars and information days.
To read more about the new EudraVigilance system, please click here.