EMA Offers New EudraVigilance Checklist for Sponsors, MAHs

Regulatory NewsRegulatory News | 26 June 2017 |  By 

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

The checklist features general testing instructions and easy-to-follow steps to assist sponsors and MAHs in the transition.

In addition, EMA notes that the ICH E2B(R3) Implementation Guide and the EU ICSR Implementation Guide provide guidance on how to apply the new ISO Individual Case Safety Report (ICSR) standard and how it should be used for the electronic reporting of suspected adverse reactions related to medicines in the European Economic Area (EEA).

The agency also notes that there will be no changes to the reporting of suspected unexpected serious adverse reactions during clinical trials until the application of the new Clinical Trial Regulation, and not all steps outlined in the checklist published Monday apply to sponsors of clinical trials but will only apply to MAHs in accordance with the new simplified reporting rules set out in the pharmacovigilance legislation.

EudraVigilance checklist and technical support plan for Marketing Authorisation Holders and Sponsors of Clinical Trials in the EEA


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