ICH: Strengths, weaknesses, and future tasks

Abstract

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) started in 1990 with the mission to harmonize technical guidelines and obligations for the development and authorization of human pharmaceuticals through the cooperation of drug regulatory authorities and the pharmaceutical industry of the main drug markets in the world. To evaluate the achievements of ICH over the last 23 years, 30 European experts were interviewed. The interviewee panel was selected to encompass representatives of both the pharmaceutical industry (20 interview partners) and the health authorities (10 interview partners). Many of the interview partners have actively contributed to ICH by leading or participating in working groups. Based on the interviews, this article highlights the strengths and weaknesses of ICH with a focus on ideas and visions to improve the status quo. © The Author(s) 2013.