The mounds of post-market safety data now being generated through social media and other non-traditional data sources are overwhelming regulators and often hindering pharmacovigilance, not improving it. Industry groups have proposed updates to ICH guidelines that aim to sort the signal from the noise, and revised guidelines are projected to take effect in two to three years.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) last revised its guidelines on post-approval safety reporting in 2003.
The pharmacovigilance landscape has since evolved dramatically, with advances in technology presenting new opportunities for identifying adverse events. Rather than rely solely on patients or healthcare professionals to actively submit spontaneous reports to regulators, the idea is to obtain information from technology that interacts with patients and providers at their home or work environment, which can then be used to provide a more complete picture of how treatments are affecting patient outcomes.
“There are substantial amounts of underutilized healthcare data that contain critical information to support more representative safety surveillance,” Beth Ann Shaleesh, Senior Director of Safety Services at CRO Parexel International Corp., told BioCentury by email.
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