Common Technical Document

An application for marketing authorisation for a medicine for human use must be submitted in CTD format. This is described in Appendix 1 of the Royal Decree dated 14/12/2006 relating to medicines for human and veterinary use and in the appendix of the European directive 2001/83/EC http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol1_en.htm .

The CTD format includes 5 sections that are identical for all member states of the European Union. The exact structure of the format is described in part 2B of the Eudralex collection, published by the European Commission
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2_en.htm .

In that volume you will find references to the European and international guidelines concerning the scientific contents of a file and also a Question & Answer document concerning the practical use of this format in  the European Union.

Sections 2 to 5 are identical for the European Union, the United States and Japan. You will find more detailed information on the website of the ICH international discussion forum (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use) :  http://www.ich.org

Last updated on 20/11/2008