The Electronic Common Technical Document

Abstract

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format has now become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. Derivatives of the CTD are becoming widely adopted in other regions, including the ASEAN countries. An electronic CTD (eCTD) was developed in parallel with the CTD and the three ICH regions now accept eCTD filings. The purpose of this article is to survey the eCTD technical requirements, the implementation by different countries and to discuss some of the practicalities involved in writing, compiling and publishing eCTD applications. The eCTD has advantages over the CTD in terms of ease of use, archiving and for life-cycle management of registration information. The eCTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the eCTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the need for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. Regulatory agencies are moving to accept online filings, but these are currently commonly made using physical media such as CD, DVD or tape. The eCTD file needs to be ‘reviewer friendly’ by use of bookmarks, hyperlinking and tables of contents in individual documents. Prescriber and patient information can now be supplied electronically using the XML-based EU PIM Data Exchange Standard and the Structured Product Labelling in the US. Many commercial software tools are available for content management, assembly, compilation, publishing, labelling, electronic validation and review. eCTDs can be developed using leased or purchased software, specialist contract services, outsourcing from software vendors or using contract research organisations.