[Objectives and organization of the International Conference on Harmonization].
The objective of the International Conference on Harmonization established since 1989 is to allow marketing of new drugs as soon as possible for patient benefit. At the same time harmonization decreases development time by harmonizing the content and the format of the registration file in the three regions: European Union, United States and Japan. ICH is a unique process involving health authorities and industry representatives of the three regions. The Conference which took place in July 1997 was the end of the first step of the process. At the meeting it was decided to pursue this harmonization activity, particularly in initiating a project devoted to the file format (Common Technical Document). The current period will be essentially focused on implementation of the common Guidelines and on their update in relation to scientific progress, the major part of the file now being harmonized in its content.
Juillet
Y
Y
Hoechst Marion Roussel, Direction des Affaires Publiques et Pharmaceutique, Romainville.
D004345:Drug Industry / Q000592:standards*; D005062:European Union; D006801:Humans; D007390:International Agencies / Q000458:organization & administration* / Q000592:standards; D007564:Japan; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D014481:United States
D004364:Pharmaceutical Preparations
Les fondements et l'organisation des conférences internationales sur l'harmonisation.