The content and format of the ICH Common Technical Document (CTD) was presented by ICH members from Japan, EU and USA. It became clear that CTD refers to that part of the documentation in a new drug application which will be harmonized within all ICH countries. However, many requirements will still differ in and among ICH countries regarding new drug applications since the national rules governing medicinal products remain different.

Examples of common areas within new drug applications are administrative data, levels of summaries and appendices, submission of case reports, etc. The work on CTD was still in progress and the forthcoming ICH-5, to be held in November 2000 in San Diego, USA, was seen as crucial in order to complete the CTD proposal and submit it for comments. It was foreseen that ICH countries may be able to implement the CTD in two to three years subsequent to its adoption in final format.

The perspectives regarding CTD were presented from Israel, Russia and Switzerland. Many difficulties were identified in direct implementation of the proposed ICH CTD in Israel and Russia where local manufacturers produce mainly generic products, which are not covered by CTD which has been tuned for new chemical entities. As an example, manufacturers may not have facilities to control humidity in stability cabinets. It was generally felt that there was a need for a transition period to introduce CTD and prior discussions with local manufacturers. If CTD required modifications to be applicable to non-ICH countries, assistance from WHO would be vital. Nonetheless, harmonization of new drug applications would enable small countries to register pharmaceuticals consistent with global standards.

It was evident that Switzerland had less difficulties than other countries in implementation of CTD, as its representative had observer status at the ICH Steering Committee and it had participated in the ICH Expert Working Group on CTD.