As ICH completes the CTD, what are the implications for generics?

Following the completion of the Common Technical Document just beforethe Fifth International Conference on Harmonization was held in San Diego, USA, last November (Marketletter November 20, 2000), the target date for voluntary submissions in the CTD format in all three ICH regions - the USA, Japan, and the European Union - has been set for July of this year, according to Nicholas Cappuccino, vice president of R&D at Apotex of Canada.

The focus of the CTG expert working groups (EWGs) will now be on issues of implementation, beginning at the next ICH Steering Committee meeting, which will be held in Tokyo, Japan, in May, Dr Cappuccino told the European Generic medicines Association's annual regulatory affairs meeting in London recently (Marketletter February 26 and this issue, page 12).

For generic drug products, implementation of the CTD promises to be much clearer in the EU than in Japan or the USA, Dr Cappuccino told the meeting. The ICH Steering Committee has stated that, "with appropriate modification, the CTD format can be applied to abbreviated and abridged applications," he noted, adding that there was no reason why this should not be the case, particularly in dealing with issues of quality. In the EU, use by generics of the CTD should be straightforward, with regulations specifying that applicants follow the Document's format - its scope is limited to format, and it does not seek to harmonize content.