EMA says impending EudraVigilance launch benefits MAHs
The Agency said the system’s revised features – to be launched on November 22, 2017 – promote the safe and effective use of authorised medicines and trial-stage candidates in the European Economic Area (EEA).
“The new system will have enhanced features for the reporting and analysis of suspected adverse reactions to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders,” said the Agency.
EudraVigilance
EudraVigilance is the platform which with the EMA, national competent authorities (NCAs), clinical trial sponsors and firms responsible for drug products – known in the EU as marketing authorisation holders (MAHs) – electronically exchange individual case safety reports (ICSRs).
ICSRs are required to report adverse events, product problems and consumer complaints associated with regulated products.
MAH benefits
EMA spokesperson Camelia Enachioiu told us the new system simplifies the reporting to ICSRs for MAHs.
“MAHs will no longer provide individual case safety reports or ICSRs – documents providing information related to an individual case of a suspected side effect due to a medicine – to national competent authorities and must submit these to EudraVigilance only,” she said.
In addition, Enachioiu said the system better detects new or changing safety issues, and the database’s public interface – adrreports.eu – allows for broader access for healthcare professionals and the general public.
Enachioiu also told us the updated system has enhanced search and data analysis capabilities, and can support larger volumes of users and reports.
Brexit
According to Enachioiu, EudraVigilance will continue to monitor authorised products and drug candidates in the UK for as long as Britain remains part of the European Union (EU).
“The system will include the UK until its withdrawal from the EU,” she told us.
“Future involvement of the UK in EU medicines regulation will depend on the outcome of the ongoing Brexit negotiations,” she added.
EMA relocation
Following Brexit negotiations in March, the EMA must relocate from its London, England-based headquarters to a new member state within two years.
According to the EMA, the relocation could impact drug approval processes for two to three years, however Enachioiu told us the move won’t affect EudraVigilance.
“It is expected that all our IT systems will remain operational when the Agency relocates to another EU country,” she told us.
EuraVigilance will be disrupted between the eighth and 21st November to facilitate the launch, however the Agency said this would not affect the direct reporting of side effects by patients and healthcare professionals to authorities and MAHs.
