International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
Recommended for Adoption at Step 4 of the ICH Process on 1 May 1996 by the ICH Steering Committee
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.i
