EMA clarification on the download of SARs from EudraVigilance

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

Due to inquiries concerning the handling of ICRs in EudraVigilance, the European Medicines Agency EMA has published a "Note for clarification".

"With the launch of the new EudraVigilance system on 22 November 2017, the simplified (electronic) reporting of suspected adverse reactions related to medicines in the format of Individual Case Safety Reports (ICSRs) by National Competent Authorities (NCAs) and marketing authorization holders (MAHs) to the EudraVigilance database became mandatory. Based on this simplification, NCAs and MAHs no longer have to report to each other directly, thus reducing duplicative reporting."

The brief document with the title "Recording by marketing authorization holders of information on suspected adverse reactions held in EudraVigilance" describes on three pages (and an additional  Annex A on "Pharmacovigilance obligations with focus on the safety monitoring and benefit-risk assessment of medicinal products") the regulatory expectations on the handling of SAR cases (Suspected Adverse Reactions) published in EudraVigilance.

According to the agency, cases which have been submitted by authorities since 22 November 2017 for own products and for such where ownership cannot be excluded should be actively monitored in EudraVigilance and recorded in the MAH database. For entries made by other MAHs, this is not generally mandatory. However, the decision and justification of not recording the data must be documented:

• "MAHs should record all individual cases of suspected adverse reactions for substances of medicinal products, for which they hold a marketing authorization in the European Economic Area (EEA) and that are submitted by NCAs in EEA Member States to EudraVigilance".
• "MAHs should decide whether they record individual cases of suspected adverse reactions for substances of medicinal products for which they hold a marketing authorization in the EEA and which were submitted by other MAHs to EudraVigilance. The decision should be based on the processes necessary for the MAHs to comply with their pharmacovigilance obligations" (Annex A). "The recording or not of these ICSRs should be documented as part of the pharmacovigilance system".
• In both circumstances the outlined provision applies to "all individual cases where the MAH cannot exclude ownership of the medicinal product reported (suspect or interacting)". The exclusion of ownership criteria are based on the principles laid down in GVP (Good Pharmacovigilance Practice) Module VI (Collection, management and submission of reports of suspected adverse reactions to medicinal products).

More information can be found on the EMA's website in: EudraVigilance training and support.