Common Technical Document module

International Conference on Harmonization. The common technical document for the registration of pharmaceuticals for human use quahty, quality overall summary of module 2, module 3 quahty, in Harmonized Tripartite Guideline, ICH, 2002. 

Module 2 Common technical document summaries Overall common technical document table of contents Introduction Quahty overall summary Non-chnical overview Clinical overview Non-chnical summary Pharmacology Written summary Tabulated summary Pharmacokinetics Written summary Tabulated summary Toxicology... 

The application should be in the format of common technical document (CTD), which became mandatory from July 2003. The regional specific requirements are in the Modules 1 and 5 of CTD, which are described below. 

As more than 95% of new medicines are worked out in the ICH regions the technical requirements for the safety, efficacy and quality of new medicines is determined at large by ICH technical guidelines. The application format for registration (marketing authorization) of new medicines in ICH and associated countries (such as Canada, Switzerland and Australia) has to follow The Common Technical Document (CTD) which provides harmonized structure and format for new product applications. This Common Technical Document is divided into four separate sections and 5 modules (see Fig. 1). The four sections address the application organization (M4 Organization), the Quality section (M4Q), the... 

The ICH Q8 guidance is currently being developed and is expected to reach the ICH Step 2 in November 2004. It is intended to provide guidance on the contents of Section State-of-the-the-Art Pharmaceutical Science. P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). 

FIGURE 10 Schematic illustration of the ICH M4 common technical document (CTD) the contents of the Quality Overall Summary (2.3) and Quality (3) modules are most relative to PAT. 

The Commission, in conjunction with the Notice to Applicants Working Party, completed its work on the incorporation of the ICH Common Technical Document (CTD) into a revision of Volume 2B of the Notice to Applicants. A schematic representation of the correspondence between the five modules of the CTD and the four parts of the European registration dossier has also been prepared in order to facilitate the transition from the old application format to the new one. The non-clinical and clinical overviews and summaries are equivalent to the present expert report described above. The clinical summary may replace the Integrated Summary of Efficacy and Integrated Summary of Safety Required by the FDA, and the Clinical Overview and Clinical Summary have been designed to replace the Japanese GAIYO. 

This chapter has described and discussed the various modules of a Common Technical Document (CTD) as presented in ICH M4. A sponsor preparing a marketing application for submission to any of the three ICH regions and to most other regulatory authorities around the world can, and probably should, utilize the recommend orders of presentation outlined in the ICH CTD guideline for quality, nonclinical, and clinical results generated to support the characterization and development of a drug candidate. 

In September 2002, the ICH issued guideline M4, Organization of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use. Each CTD contains 5 modules ... 

The Common Technical Document For the Registration of Pharmaceuticals for Human Use Quality—M4q(Rl) Quality Overall Summary of Module 2 Module 3 Quality... 

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