ICH4 Achievements "Exceed Expectations"

Progress at the Fourth International Conference on Harmonization ofTechnical Regulations for Registration of Pharmaceuticals for Human Use in Brussels, Belgium, July 16-18 (see also page 17 "certainly exceeded the most optimistic expectations," according to an official report released after the meeting.

ICH4 saw Phase I of the harmonization process completed. A further nine tripartite harmonized guidelines were finalized; there are now 36 such guidelines. Consensus was reached on toxicity testing protocols, which will mean a major drop in the number of animals needed to assess new drug safety, and a major step has been taken towards developing harmonization quality specifications for new chemical substances and products, with a draft consensus guideline released for consultation.

A second phase of harmonization is to be launched, with broader horizons. A major project concerns the Common Technical Document, described as a logical progression from a single, harmonized set of technical data for new drugs to a common technical information package with the same format and content that could be submitted in all three ICH regions. It was also noted that ICH is committed to maintaining the harmonization achieved, and is setting up maintenance procedures and mechanisms to void future divergences.