EMA: Revised Guideline for Entry into Human

Guidance outlines strategies to identify and mitigate risks for trial participants

The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants.

The revision takes into account the fact that in the past 10 years trial protocols have become increasingly complex and now often include different parts within a single clinical trial protocol, aimed at assessing for example single and multiple ascending doses, food interactions, or different age groups.

The revision considered the comments received during a public consultation and a follow-up workshop that took place in March 2017.

EMA will make available all comments received, both on the initial concept paper and on the revised guideline, in September 2017.

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