Common Technical Document overview

International Conference on Harmonization. The common technical document for the registration of pharmaceuticals for human use safety, nonclinical overview and... 

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... 

Guidance on the content of the Nonclinical Overview (NCO) is given in ICH M4S, Common Technical Document for the Registration of Pharmaceuticals for Human Use—Safety, CHMP/ ICH/2887/99 Rev 1 Safety. This guideline also gives information on the structure and content of the narrative and tabular summaries that contain the more detailed information. 

When the new ICH Common Technical Document is fully adopted, the pharmaceutical physician may be called upon to write an expert report or a clinical overview. It is essential that whoever writes the report or overview should have a good understanding of the trial. Inaccuracies are too frequent. The report is a comprehensive and critical review of the data submitted in the license application and should not be more than 25 pages long (30 pages in the case of the clinical overview). The object of the report is to facilitate the review by the assessor and it should address the properties of safety and efficacy of the study drug, with cross-reference to... 

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. 

Figure 16.2 Diagrammatic representation of the ICH common technical document (CTD) (overview). 

International Conference on Harmonization, The Common Technical Document for the Registration of Pharmaceuticals for Human Use Safety, Nonclinical Overview and Nonclinical Summaries of Module 2, Organization of Module 4, Harmonized Tripartite Guideline, ICH, 2002. 

Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) ICH, 2001) The CTD provides for a harmonized structure, content, and format for new product applications. The document is divided into four separate sections. The four sections address the application organization (M4 organize), the quality section (M4Q), the safety section (M4S) and the efficacy section (M4E) of the harmonized application. Drug metabolism and pharmacokinetic data should be summarized in the safety section that includes the nonclinical overview, nonclinical written summaries, and nonclinical tabulated summaries. More specifically, in Section 2.6.4.S metabolism (interspecies comparison) of the written summaries, the following data should be included ... 

Accordingly, the final reporting of a fiill performance assessment is an inq>ortant step which needs careful planning. The overview documents must be sufficiently simple and diversified with respect to display material that they can be grasped by a wider audience the back-vp technical documentation must be trace le and of adequate quality to allow review by regulatory authorities or also witiiin the scope of the increasingly common peer reviews at an international level. 

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