Common Technical Document organisation

CPMP/1CH/2887/99 Note for guidance on Organisation of Common technical document Draft consensus guideline (released for comment July 2000)... 

Figure 7.1 Common technical documentation. (Source ICH Harmonised Tripartite Guideline. Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use, M4, Step 4 Version (2004).)...

The common technical document (CTD) (ICH M4) is now a requirement. The CTD is the agreed common format for the preparation of a well-structured application to the regulatory authorities and has had an impact on all organisations as database integration and electronic submissions become more common. 

ICHM4 Organisation including the granularity documents that provides guidance on document location and paginations (The common technical document) (Revised annex granularity document, November 20(B) Step 5... 

Table 19.6 Organisation of the Common Technical Document (CTD) for the registration of pharmaceuticals for human use...

International Conference on Harmonization (ICH) (2004), M4 Organisation of the common technical document for the registration of pharmaceuticals for human use, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH, Geneva. 

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. 

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