ICH Steering Committee Expert Groups Meet

The fourth International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH 4) is to be held in Brussels, Belgium, July 16-18, 1997. This will mark the success of the first phase of international harmonization for pharmaceuticals under the ICH process, and will overview the impact of this harmonization on the development process for new medicinal products.

Also at ICH 4, senior members of government and industry will establish the objectives and orientation for the next phase of international harmonization, says a report from the ICH Steering Committee, which met this month near Washington DC. Also meeting were the Expert Working Groups, which achieved three important elements of harmonization, it says.

GCP Guideline For Clinical Trials Adopted First, the harmonized tripartite guideline on Good Clinical Practice for the conduct of clinical studies was finalized and adopted. This consolidated document sets a tripartite standard for clinical trials, covering preparation, monitoring, reporting and archiving, and incorporating already-agreed addenda on the Essential Documents and the Investigator's Brochure. It will now be published and adopted in the European Union, Japan and the USA. It further supports the acceptance of submissions of clinical trial data generated in accordance with this standard.