Common Technical Document conference

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

International Conference on Harmonization. Organization of the common technical document for the registration of pharmaceuticals for human use, in Harmonized Tripartite Guideline, ICH, 2002. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic M4 Organisation of Common Technical Document for the Registration of Pharmaceuticals for Human Use, CPMPIICHJ2887J99. London European Agency for the Evaluation of Medicinal Products, 2000. 

Prior to the Conference, during which the ICH Expert Working Group and Steering Committee met, the ultimate objective of ICH 5 was achieved. The Common Technical Document (CTD) was agreed (see Table 19.6 for finalised CTD), setting out a harmonised format (see below) for regulatory submissions. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

The U.S. Food and Drug Administration (FDA) defines novel (new) pharmaceutical excipients as those substances used in the United States for the first time in a human drug product or by a new route of administration (1). The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) includes sections in its Common Technical Document (CTD) that details the information required for the approval of novel (new) excipients. Information on the control of excipients is included in Section P.4 of the CTD, and any additional information that may be required should be included in Appendix A.3 of the CTD. 

International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic M4 Organisation of Common Technical Document for the Registration of Pharmaceuticals for Human Use CPMP/ICH/2887/99. London European Agency for the Evaluation of Medicinal Products, 2000. International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic Ml Medical Terminology (Draft). Available at hllp //www.ifpma.org/ich5e.html. Accessed July 21, 2001. 

International Conferences on Harmonisation. URL http // www.ich.org. The ICH Web site provides information on the structure and purpose of this consensus-building initiative, as well as the process for evolving recommendations regarding technical requirements for human drug registration worldwide. Separate sections address existing Guidelines, the Common Technical Document, and MedDRA. 

Electronic Common Technical Document Specification. ICH M2EWG. Draft Guidance. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH eCTD Specification V 2.0. February 12, 2002. 

A regulatoiy submission will typically take the form of the Common Technical Document (CTD), which was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Established in 1990, the ICH is a collaboration between the regulatory authorities and pharmaceutical industries of Europe, Japan and the USA their mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. ... 

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