For over 10 years, FDA has been involved in the International Conference on Harmonisation (ICH). ICH represents one of the most successful partnerships between the pharmaceutical industry and regulatory authorities to date. ICH's efforts to harmonise on the content of drug and biologic marketing applications culminates in the establishment of the Common Technical Document (CTD). Concurrent with the CTD efforts, the ICH M2 technical working group, Electronic Standards for the Transfer of Regulatory Information (ESTRI) is developing a standardized technical specification to transport data in the CTD format to the various potential international recipients.
The technical approach for an electronic CTD or eCTD developed by the M2 consists of a specification describing the appropriate formats for data and document files. This includes an XML Document Type Description (DTD) that serves as the primary structure for containing the metadata and files in a manner that can be validated by the recipient. The approach will allow transport of CTD data to regulatory recipients but is not intended to be a review application or tool. The transport file content can be mapped to any review application appropriate for the recipient.
In addition to transport formats, FDA has also been exploring the use of XML technologies for web-enabled software development. A proof-of-concept application called the Cumulative Table of Contents (CTOC) was developed to explore the look and feel of this approach. This "conceptual approach" was shared with a variety of parties including PhRMA at the Electronic Regulatory Submission Working Group and at an open public workshop.
As a result of the concurrent efforts, there is some confusion regarding these two approaches and speculation as to whether this signals a shift in FDA’s emphasis and commitment to the ICH initiative. The CTOC tool is an FDA internal review tool and should not be construed as a new direction in the development of a transport format. The intent of CTOC project is to explore and familiarize the various parties with some different approaches involving XML, and not to create a new, competing transport approach.
We wish to stress that FDA continues to support the ICH M2 approach to the international transport format and the eCTD development process.