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COMMON TECHNICAL DOCUMENT (CTD)
The Common Technical Document (CTD) is a set of conditions for application dossier for the registration of Medicines and intended to be used crossways Europe, Japan and the United States. It was developed by the European Medicines Agency (EMEA, Europe), the Food and Drug Administration (FDA, U.S.) and the Ministry of Health, Labor and Welfare (Japan). The CTD is regulated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)
The Common Technical Document is divided into five modules:
The module 1 contains different documents contrary to the other modules from region to region. Therefore the module 1 is not regarded as part of the CTD. In Europe the following elements in the module 1 are to be found:
1.1 Comprehensive tables of contents of the entire dossier
1.2 Request form for permission
1.3 Product information: Summary of the characteristics of the medicament (SPC), Package inserts, Information for packing
1.4 Information about experts involved
1.5 Specific requirements for different kinds of request
1.6 Evaluation of environmental risks
1.7 Information to the market exclusivity for Orphan medicament
1.8 Information to Pharmacovigilance System
1.9 Information too outside of the European Union accomplished clinical studies
Module 2
Module 2 gives an overview of the information existing in the dossier to the medicament and integrates these with evaluations and conclusions.
2.1 Table of contents of the modules 2 to 5
2.2 Introduction - short representation of the pharmaceutical class, the damage mechanism and intended clinical application.
2.3 Summary to the pharmaceutical quality, Overview and summary of the data from module 3.
2.4 Overview, integrated analysis of the not-clinical information in the dossier (overviews to the not-clinical test strategy, Pharmacology, Pharmacokinetic and Toxicology as well as an integrating overview and conclusions).
2.5 Clinical overview, integrated analysis of the clinical information in the dossier (reason for product development, overviews to Bio pharmacy, clinical pharmacology, Effectiveness, security as well as conclusions to use and risks)
2.6 Summaries and table overviews of all accomplished, in module 4 represented not-clinical studies to the pharmacology, Pharmacokinetic and toxicology.
2.7 Clinical summaries to biopharmaceutical studies, clinical studies, clinical studies to the effectiveness, summaries to clinical security, literature data
Module 3
Module 3 places in detail the chemical-pharmaceutical and biological data to Medicine material and to as Medicine form available product. For data to medicine materials can also on Drug master file are referred, if the medicine material manufacturer and the medicament manufacturer are not identical.
3.1 Table of contents for module 3
3.2.S Data to the material, the structure, the material properties, the manufacturer, the production process, the raw materials, the intermediate products, that Process validating as well as to the development of the production process, furthermore information for material characterization, to impurities, specifications, analysis methods and of them Validating, to reference substances and finally data for the stability of the material under different environmental condition.
3.2.P data to the product; Description and exact composition of the medicament for all medicine forms and dosages, under it information to all Auxiliary materials as well as again data to production, process validating, analysis, primary packaging means and stability of the finished product.
3.2. A of appendices, those if necessary the description of special processing units or equipment, which or the description of new auxiliary materials contain safety evaluation of additives.
3.2. R regional information, with which it acts over for the appropriate region (European Union, USA or Japan) specific documents for the quality of the medicament or the active substance.
3.3 Literature data
Module 4
Module 4 represents in detail all study reports to all not-clinical (=) studies not accomplished with humans.
4.1 Table of contents for module 4
4.2 Study reports to the pharmacology, Pharmacokinetic and toxicology (Toxicity regulations, Mutagenicity examination, carcinogenicity, Reproduction toxicology, local compatibility, Immune toxicology and further)
4.3 Literature data
Module 5
Module 5 represents in detail all study reports to all clinical studies accomplished with humans.
5.1 Table of contents for module 5
5.2 Tabular overview of all clinical studies
5.3 Study reports for bio pharmacy, Pharmacokinetic, Pharmacodynamic, effectiveness and security, furthermore information to experiences with the product already marketed (so available) and all Case reports form and a listing of all participating patients.
