Common Technical Document format

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. 

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. 

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). 

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. 

Subsequently, following agreement on Common Technical Document (CTD) format for the dossier. Commission Directive 2003/63/EC of 25 June 2003, replaced Aimex 1 of Directive 2001/83/EC (detailing scientific and technical requirements) with a new Annex (detailing scientific and technical requirements in CTD terms). Provisions are made in the legislation for the omission of data in certain circumstances where information is already available to the regulatory authorities from other sources, for example. 

Directive 75/318/EEC required that the dossier be presented in four highly structured parts Parts I, II, III, and IV. Directive 83/570/EEC was the amending Directive, which introduced the requirements for a draft SPC to be produced by the applicant. Volume 2B of The Rules Governing Medicinal Products in the European Union gave a detailed breakdown of the structure of a European regulatory dossier. This format was accepted until the end of June 2003 when a new format known as the Common Technical Document (CTD) became mandatory (see later). 

Information on the Common Technical Document Presentation and format of the dossier CTD http //pharmacos.eudra.org/F2/eudralex/vol-2/ B/ctd2003july.pdf. 

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. 

The application should be in the format of common technical document (CTD), which became mandatory from July 2003. The regional specific requirements are in the Modules 1 and 5 of CTD, which are described below. 

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). 

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... 

BLA—Biologies License Application (eCTD and eBLA format) eCTD—Electronic Common Technical Document IDE—Investigational Device Exemption IND—Investigational New Drug Application (eCTD and eIND format)... 

For more information on submission of an ANDA in Electronic Common Technical Document (eCTD) format, please go to http //www.fda.gov/cder/ regulatory/ersr/ectd.htm. 

Guidelines have been established to assist sponsors in the preparation of applications to register new prescription or other high-risk medicines for human use. The format for applications is the Common Technical Document. It is a format that is also used in other parts of the world. 

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

The common technical document (CTD) is a method of submitting an NDA. It is a very useful outcome of ICH discussions regarding the creation and implementation of standardized document formats. While individual regulatory agencies still have different requirements of specific content of various documents, this standardized format is a considerable step forward in the harmonization of submissions to multiple agencies. This guideline, adopted by the ICH regions (Europe, Japan, and the United States) in 2000, has subsequently been implemented, and other countries may continue to adopt it. 

The current global initiative to harmonize electronic submission format and content requirements effectively creates one standard data package for drugs or biologies. Thus, the eNDA (electronic new drug application) or eBLA (electronic biologies license application) will eventually be replaced by the eCTD (electronic common technical document). 

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. 

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