Common technical document

Some internationally harmonized guidelines regarding specifications and tests, impurities and validation of analytical methods have particular relevance to the development of chiral drugs and are discussed below. In addition, the impact of work on the common technical document is considered. 

Figure 6.1 Diagrammatic representation of the organization of the Common Technical Document (CTD) (from ICH M4 Guide).

M4(R3) Common Technical Document Superstructure document granularity... 

Electronic Common Technical Document (eCTD) specifications. www.ich.org... 

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. 

Readers may also be aware that under the auspices of the ICH a document is being developed on the organization of the Common Technical Document. It is intended that this will result in a common format (and, to at least some extent, content) of marketing authorization applications in the jurisdictions of those party to the ICH process (Japan, the EEA, and the United States). At the time of writing, a draft document had been circulated for comment. When adopted and implemented, this will result in a considerable amendment to the format and sequencing of information in a marketing authorization application. 

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

The main feature of the harmonisation is guidelines and Common Technical Documents (CTD). The CTD gives a harmonised format and content for new product applications and in 2003 there was an agreement on implementation, in USA, Europe and Japan. 

The Common Technical Document for the Registration of Pharmaceuticals for Human use 08-24-00... 

Common Technical Document The Changing Face of the New Drug Application... 

Diagrammatic Representation of the Organization of the ICH CTD Common Technical Document... 

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).)...

A Sponsor submits a clinical trial application to the Competent Authority in each member state where the trials are to be conducted. The Competent Authority has 60 days to review and approve or reject the application. Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing, and quality controls on the drug, and supporting data, such as (1) chemical, pharmaceutical, and biological data, (2) nonclinical pharmacological and toxicological data, and (3) clinical data and previous human experience. The supporting data are submitted in the Common Technical Document (CTD) format (see Section 7.11). 

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

---