New French Clinical Trial Rules Focus on Phase I
New clinical trial rules have been introduced in France covering aspects such as safety reporting for volunteer trials, trial site authorization, and a clearer distinction of trial type in terms of risk level.
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Better Risk Assessment And Dose Determination Key To EMA's Plans For Updated Phase I Trial Guideline
Proposed revisions to the European Medicines Agency's guideline on first-in-human studies are intended to help identify and reduce the risks to study participants by making better use of non-clinical data in areas like the choice of the therapeutic dose, the dose escalation strategy, and the criteria for stopping a trial.
The French regulator ANSM says that pharmaceutical companies and ethics committees have shown keen interest in its pilot project intended to test how the clinical trial application process will work under the EU's Clinical Trials Regulation, with 11% of all trial applications being filed within the framework during its first six months1.
Under EU rules, once a medicinal product has been placed on the market in a country of the EEA – the EU plus Iceland, Liechtenstein and Norway