Specht Sebastian, Klingmann Ingrid
1 Pharmaceutical Division, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
2 Pharmaplex bvba, Brussels, Belgium.
Ther Innov Regul Sci. 2014 May;48(3):357-361. doi: 10.1177/2168479013520161.
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.
人用药品注册技术要求国际协调会议（ICH）始于1990年，其使命是通过世界主要药品市场的药品监管机构和制药行业的合作，协调人用药品开发和批准的技术指南及义务。为评估ICH在过去23年取得的成果，采访了30位欧洲专家。受访者小组的选择涵盖了制药行业（20个采访对象）和卫生当局（10个采访对象）的代表。许多采访对象通过领导或参与工作组，为ICH做出了积极贡献。基于这些采访，本文重点介绍了ICH的优势与不足，并着重阐述了改善现状的想法和愿景。
