EMA Publishes Technical Guide on Reporting Individual Adverse Events

The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. The standard, ISO EN 27953-2, takes effect July 1.

Referred to simply as ISO ICSR, the standard harmonizes the format for reporting individual cases of suspected side effects in patients taking a drug anywhere in the world. It also strengthens the protection of personal data in ICSRs collected by drugmakers and regulators, the EMA notes.

The guide,developed jointly by the EMA and the heads of Europe’s drug regulators, outlines exact formatting and other technical requirements that companies should use in preparing ICSRs. Among the issues discussed are privacy protection standards, use of local languages in reports, electronic system testing needs, how to characterize the therapy’s role in the event and classification and recoding of the information.  

The finalized guide also draws on the International Conference on Harmonisation’s E2B (R3) guideline on clinical safety data management. The EMA called it a major step towards an enhanced EudraVigilance database, which serves as a searchable repository of all reported adverse drug events in the European Economic Area.

Access the guide at www.fdanews.com/01-22-15-EMA-Postmarket-Surveillance.pdf. — Bryan Koenig