News story

New guidance on good clinical practice

Consultation on new ICH guidance document on good clinical practice.

A pile of tablets

The European Medicines Agency (EMA) is consulting on a new International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document on good clinical practice (GCP). The aim of the guidance is to provide a unified standard for the European Union, Japan and the United States so that there is consistency around clinical data requirements in these regions.

To respond to the consultation you should complete the consultation template and email it to ich@ema.europa.eu.

The deadline for comments is 31 January 2016.

Published 7 September 2015