European Medicines Agency’s Consultation Response

We submitted a joint response with the Faculty of Pharmaceutical Medicine to the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products” consultation (European Medicines Agency) in February 2017. The adopted guideline was published in July 2017 and will come into effect on 1 February 2018.

We are broadly happy with the outcome. Our comments, along with the Faculty of Pharmaceutical Medicines’ comments were frequently accepted and the document is much improved by the new definition of the purpose of First-In-Human trials at the beginning of the Introduction. This was directly proposed by the joint response and has apparently been used nearly word for word.