ICH Guide On Selective Reporting Of Safety Data Faces Major Rewrite
The International Council for Harmonisation is making big changes to its E19 guideline that proposes taking a targeted approach to safety data collection in some late-stage clinical trials. The draft guideline, which is largely similar to the US guideline on this topic, drew varied comments from stakeholders, including those from the EU.
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A draft international guideline that proposes limiting safety data collection in premarket and postmarket trials if the drug’s safety profile is sufficiently characterized has drawn a varied response from a range of stakeholders in the EU.
The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.