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GMP News No. 193
7 May 2002
Have you already prepared yourself for the changes regarding marketing authorisations for drugs?
CTD Transition Period Runs Out on 1 July 2003
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 information:
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 Characteristics) etc.
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 competent experts.
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 (CPMP/ICH/2887/99 Safety).
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 Efficacy).