Industry seeks ICH revisions to curb influx of irrelevant pharmacovigilance data

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. ...