Pharmacovigilance Trends: Getting To Know The DSUR

By Malarkodi S. Moorthy, M.Sc., M.Phil., Medical Writer

In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis.

Although both the Food & Drug Administration (FDA) and EU Clinical Trial Directive required what is termed as IND AR and ASR, respectively, the content, format and timings differed between the US and EU reports. Considering that most contemporary trials are multinational, a need was felt towards harmonizing these requirements and to provide a uniform standard acceptable to all regulatory agencies across the world. The concept of a DSUR was first introduced by the CIOMS VI working group and taken forward by the CIOMS VII working group. In 2008, the ICH published a draft guideline E2F on DSUR, which has been updated in August, 2010, incorporating background, objective and scope of DSUR and providing guidance on DSUR contents.

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