11 September, 2017

Did you know the EMA guideline on first-in-human trials is changing?

By Sarah Johnson

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The EMA has revised its guidance on first in-human clinical trials; the revision comes in to effect on February 1, 2018 and extends the existing EU guidance to address first in-human (FIH) and early phase clinical trials with integrated protocols. Be sure to understand what these changes mean for you.


The original guideline was released in 2007, in the last 10 years clinical trial designs have evolved.  The revised guideline includes strategies to mitigate and manage the potential risks for trial volunteers in the transition from non-clinical to early clinical development and addresses the increasing complexity of protocols for FIH clinical trials in recent years.  The previous version of the guideline focused on single ascending dose studies. In the last 10 years protocol design has evolved to a much more integrated approach with sponsors conducting several steps of clinical development within a single protocol for example multiple ascending doses, food interactions or differing age groups.

The guidance also includes considerations on: quality, dosing selection planning and conduct of a FIH trial including protocol design and criteria for stopping a study as well as the handling of adverse events.


The guidance addresses non-clinical issues for consideration prior to administration of an investigational medicinal product (IMP) in humans.

Pre-clinical studies cannot identify all adverse effects that may occur in humans therefore in early clinical development of human medicinal products there is an element of uncertainty in relation to the possible side effects, risks of a novel drug and risks that derive from the characteristics of the population to be studied.

How does the revised guideline impact us?

The guideline discusses how the non-clinical data in PD, PK and toxicology and their translation to humans are important basis for the planning and conduct of FIH/ early phase clinical trials.

To learn more about what the revised guideline involves, read the adopted guideline in full.

Category // Pharmaceutical development, EMA guidelines