FDAnews Drug Daily Bulletin

ICH Begins Work on Safety Data Collection Guideline

Aug. 1, 2017

The International Council for Harmonisation published a concept paper and a plan for a new efficacy guideline on optimizing safety data collection. The guideline, E19, will outline appropriate circumstances for using a targeted approach in late-stage premarketing and postmarketing clinical trials.

The ICH plans to convene an expert working group and develop the guideline over the next three years, delivering adopted text to the FDA, EMA and other international agencies in June 2020.

The working group is expected to draw from the fields of clinical medicine, biostatistics and regulatory science, as well as consults with patient representatives. The first face-to-face meeting is set for November.

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