Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

  • Email
  • Help
Current effective version

Adopted guideline

Revision 1 enters into effect 01/02/2018 - see below

Reference numberCHMP/SWP/28367/07
Effective from01/09/2007
KeywordsFirst-in-human, phase I clinical trials, identification of risk, non-clinical requirements, animal models, minimal anticipated biological effect level (MABEL), risk mitigation strategies
DescriptionThis document addresses non-clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also addresses the design and conduct of trials in the initial phase of single and ascending doses during the clinical development.

Document history

Revision 1


Adopted guideline



Draft guideline

Concept paper

Published: 25/07/2017
Coming into effect: 01/02/2018


Published: 15/11/2016

Published: 21/07/2016

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/09/2007–present


Published: 03/05/2007


Published: 22/03/2007

Related content

How helpful is this page?

Average rating:

 Based on 5 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
1 ratings
4 ratings

Tell us more