The CTD (Common Technical Document) was proposed by the ICH working committee (the International Conference on Harmonisation) back in the early 1990s and finally agreed upon in November 2000. Its purpose was to provide life sciences companies with a common structure for registering drugs for human use to the regulatory agencies. The FDA was the first agency to adopt the CTD as a common structure for receiving product registrations from companies. Although the CTD submissions were initially delivered in paper, the eCTD (electronic Common Technical Document) was implemented using the same structure but delivered to the agencies in an electronic format with a few additional specific requirements that were not included in the original CTD.
The CTD structure consists of 4 modules and 1 regional module. The following diagram clearly defines the relationship between the modules:
Module 1 will be the same in structure, but different in content, for each regional agency the application is submitted to. These regional differences (US, EU, Japan , Canada and Taiwan ) are defined and maintained in the DTD (Document Type Definition) in accordance with ICH specifications .
What do you need to consider before implementing an eCTD solution?
Submission Ready Documents
Savings from using eCTD over Paper Filing
When will eCTD become compulsory?
Although agencies will accept paper CTD registrations in Europe , several are insisting the documents are converted into PDF (Portable Document Format), compiled into the CTD structure and delivered on electronic media such as CD and DVD. For certain registrations the FDA will only accept applications in the eCTD format. The move towards an electronic format is steadily increasing in popularity with agencies, and it is expected all agencies will adopt the eCTD by 2009.
Speed of Filing
Managing the versions of your documents will become imperative to ensure you do not provide the agency with out-of-date information that could result in your submission not being validated. As you submit variations (or supplements and amendments in the Unite States ) to your application using the eCTD, the importance of life cycle management becomes evident.
Converting your existing legacy documents to PDF with the appropriate granularity and correct attributes is a good first step, organising your electronic documents is essential and having a process in place to manage and maintain your applications (updates or sequences as they are known in eCTD terms) should be your ultimate goal.
This article has provided a summary of some of the considerations to achieve what will become a compliant registration requirement in the future.
Further information on eCTD specifications can be found on the ICH website http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf
Read more about electronic submissions, 21 CFR Part 11 and document management to improve time to market: