European Medicines Agency





The European Medicines Agency has released for public consultation a concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products'

The current guideline mainly focuses on non-clinical aspects of drug development and the use of animal data and reflects the practice at the time it was developed which focused on a single ascending dose (SAD) design for first-in-human (FIH) trials.  

Since then, integration of the non-clinical data available before FIH administrations and the pharmacokinetic (PK), pharmacodynamic (PD) and human safety data emerging during a trial has also evolved. Consequently, the practice has evolved and many FIH trials are now performed with integrated protocols potentially combining a number of different study parts, e.g. single and multiple ascending doses (SAD and MAD), food interaction, different age groups and early proof of concept or early proof of principle parts. FIH and early phase CTs with multiple study parts are, therefore, increasingly being submitted for regulatory review to National Competent Authorities as part of a single CT application.

The document open for consultation is available by clicking here.

Comments should be provided using this template. The completed comments form should be sent to

Please note that the deadline for comments is 30 September 2016.


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