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Tag Archives: first-in-human trials

EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by the CHMP on 20 July 2017. It will come into effect on 1 February 2018. The revised Guideline is the outcome of EMA’s