New Eudravigilance System Launched by EMA
The new Eudravigilance system, aimed at improving adverse event reporting and safety monitoring, was launched today (November 22nd 2017).
The new system will allow for better collaboration with the World Health Organisation (WHO) by providing access to the WHO’s Uppsala Monitoring Centre (WHO-UMC).
New enhancements to the Eudravigilance system are:
- 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 searchability 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.
From today further legal obligations will apply to the mandatory electronic reporting through Eudravigilance. The additional elements are outlined here.
There are elements that remain unchanged. They are:
The reporting of adverse reactions by patients and HCP’s to national competent authorities remains unchanged.
The reporting of suspected unexpected serious adverse reactions during clinical trials remains in place until the application of the new Clinical Trial Regulation.
If you have any queries regarding Eudravigilance and how we can help your company, then please get in touch by calling us on 00353 52 61 76706 or by completing the form below.