Common Technical Document safety

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

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... 

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. 

Common Technical Document. This document will provide an international standard format for submitting safety and efficacy information about a new drug. 

If harmonization can be achieved, as it has been, across sufficiently broad areas of quality, safety and efficacy, there is no logical reason why a common technical document (CTD) or dossier cannot be prepared that would be acceptable to all dmg regulatory authorities. Movement to a CTD would appear to be the next step toward further internationalization. 

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. 

Efficacy 12 topic headings 16 guidelines Safety 7 topic headings 10 guidelines Quality 7 topic headings 18 guidelines Medical Dictionary MedDRA Electronic Standards ESTRI Timing of Preclinical Studies Common Technical Document CTD... 

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 ... 

Anon (200Id) ICH topic M 4 common technical document for the registration of pharmaceuticals for human use - organisation CTD, pp CPMP/ICH/2887-99 Anon (2001e) ICHS7A safety pharmacology studies for human pharmaceuticals, pp CPMP/ICH/ 539-00... 

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