We would like to remind you of the fact that starting from 1 July 2003 all new applications
submitted to the registration authorities have to be in the EU CTD format.
The new EU CTD format will be mandatory for all kinds of
procedures for marketing authorisation, i.e. for centralised, decentralised or national procedures as
well as for all products to be approved (NCEs, radiological drugs,
vaccines, herbal medicinal products etc.)
As a reminder, here some background
The Guideline 'Common Technical Document' has been
developed by the appropriate ICH Expert Working Group. It was passed in Step
4 of the ICH process in November 2000 for adoption to the regulatory
bodies of the European Union, Japan and the US. Since then it has been necessary to
prepare the implementation of the CTD by making the necessary changes to
the corresponding laws. In Europe, the transition period for the implementation runs
out on 1 July next year, i.e. from this date all dossiers for a marketing
authorisation have to be submitted in the CTD format.
In Europe the CTD was integrated with the Notice to Applicants (NTA)
last year. The structure of the dossier in the CTD format is now described in detail in The rules governing medicinal products in the European
Union, Volume 2 Notice to Applicants, Volume 2B Presentation and content
of the dossier Common Technical Document (CTD), October 2001. (The
document can be downloaded from the EU homepage at http://dg3.eudra.org.)
We would like to stress once more that the CTD
is just an internationally standardised format
for the dossier for a marketing authorisation; it does neither
describe its contents nor its extent.
The CTD is divided into 5 modules, which is shown clearly in the form
of a diagram in the document mentioned above.
Module 1 - the 'non-common
part', which varies in the different countries - contains
general data, like the application itself, the SPC (Summary of Product
The Modules 2, 3, 4, and 5 are the
real 'common part', in which the
documents for proving the quality, efficacy and safety are described.
This part of the dossier has the same structure in all regions.
Module 2 demands the existence of an overview and summarising
evaluations of quality, toxicology/pharmacology and clinical trials (Quality
Overall Summary, Nonclinical Overview/Summary, Clinical
Overview/Summary). These documents have to be written and signed by
In the Modules 3, 4, and 5, detailed information and data on the three
topics just mentioned have to be documented:
Module 3 ('Quality') contains details on the chemical, pharmaceutical
and biological documentation. Further information on the structure of this
module can be found in Guideline M4Q (CPMP/ICH/2887/99 Quality).
The documentation of the detailed toxicological and pharmacological
part is provided in the form of the 'Nonclinical Study Report' in
Module 4. The documents in Module 4 should be structured in
accordance with the Guideline M4S
Data on clinical trials are documented within the framework of the 'Clinical Study
Report' in Module 5. Further details concerning the structure
of Module 5 are laid down in the Guideline M4E (CPMP/ICH/2887/99
The above-mentioned Guidelines M4Q, M4S
and M4E can be downloaded from the ICH homepage (http://www.ich.org)
and/or the EMEA website (http://www.emea.eu.int).
Dr. Barbara Jentges