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Romania's regulator abolishes paper-printed SUSARs

This article was originally published in Scrip

Executive Summary

Romania's medicines agency (ANM) is abolishing double reporting (on paper and electronically) of SUSARs (suspected unexpected serious adverse reactions) in clinical trials. From September 1st sponsors are requested to submit the reports online only. If they are unable to do so, they must inform ANM’s pharmacovigilance department and set up a deadline when they will be able to provide electronic reports. The agency also reminded sponsors that it has started reporting to EudraVigilance, the European pharmacovigilance database. The requirements for electronic transmission of ICSRs (individual case safety reports) and SUSARs are available on its website.

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