EU Clinical Trials Delayed By Poor Reference Safety Information
EU regulators are increasingly raising objections over the reference safety information that companies include in their clinical trial applications and updated investigator's brochures.
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Sponsors of clinical trials in the EU have recently been inundated with objections from regulators for incorrectly managing their clinical trial reference safety information, which in turn has resulted in these trials being significantly delayed. A UK MHRA inspector discusses some of the common issues identified during inspections on this front.
The schedule for getting the EU's clinical trial portal and database up and running seems to have slipped again, this time by almost a year compared with earlier estimates. As currently forecast, the new system is not likely to be in place, or the provisions of the new Clinical Trial Regulation (CTR) in effect, until the autumn of 2018.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.