The European Medicines Agency (EMA) has taken another step toward the creation of a database of all suspected adverse reactions reported within its jurisdiction. The EMA laid out the technical details of the system and how it will affect biopharma companies in a 100-page guide it published this week.
European legislators mandated the creation of an adverse event database in the pharmacovigilance law that came into force in 2012. Since then, the EMA has worked on the technical specifications of such a system, culminating in the publication of its guide. The document details the process for electronically sending individual case safety reports (ICSRs), as well as the format the files should take and content they must include.
By standardizing ICSRs in Europe--and around the world through the ISO ICSR initiative--regulators hope to improve the quality of data collected, as well as the ease with which researchers can search and analyze the files. If successful, the standardization agenda will allow regulators to make faster, more accurate assessments of the safety of medicines. The aim is to ensure a drug like Vioxx--which was retrospectively linked to 28,000 heart attacks--is identified and withdrawn more quickly than in the past.
IT assets underpin EMA's strategy to achieve this goal. The EMA guide is intended to help software providers and IT developers as work on pharmacovigilance databases gets underway. ISO ICSR is due to come into operation on July 1, 2016.
- read the release
- here's the guide (PDF)