ICH Steering Cttee sees progress with CTD

Considerable progress was made at the meeting of the InternationalConference for Harmonization Steering Committee and its technical working groups in Chiba, Japan, in late May, on the regional implementation plans for submissions to be made in the Common Technical Document format. From July 2003, submission in the CTD format will be expected in the USA and mandatory in both the EU and Japan.

The Steering Committee signed a Step 2 for testing of the electronic CTD. Real-case testing of the eCTD by all parties will now go ahead, and definitive Step 2 documents on the eCTD are expected to be signed off in October in Brussels, Belgium.

A satellite meeting on biotechnological and gene therapy products noted the need to continue fostering the exchange of information under ICH auspices in relation to emerging scientific information on such products. Dose definition and standardization, virus shedding and germ-line integration were identified as ICH priorities, and it was recommended that a workshop be held in Washington DC, USA, next spring to review technical issues related to dose definition and standardization.