Checking in on the Status of Electronic Application Submissions
A few years ago, I was the project manager for a system that tracked the status of drug products worldwide for a large pharmaceutical company (e.g. whether a product was submitted for approval, approved, actively marketed, withdrawn, etc.). Back then, health authorities, such as the FDA in the US and the EMEA in the European Union, were in the early stages of moving from paper submissions for marketing applications to electronic submissions that conformed to the electronic Common Technical Document (eCTD) specifications. I thought now would be a good time to check in and see where things stand with the move to electronic submission.
The eCTD is a specification designed by the International Conference on Harmonization (ICH) to provide an interface for pharmaceutical companies to transfer regulatory information (such as marketing applications, renewals, variations, etc.) to health authorities. The eCTD specification consists of five modules:
- Administrative Information and Prescribing Information
- Common Technical Document Summaries
- Quality
- Nonclinical Study Reports
- Clinical Study Reports
Module 1 is regional in nature, and the requirements and structure of this module varies from country to country. Modules 2-5 are the same for all countries that adhere to the specification.
An application for marketing authorization may consist of hundreds to thousands of distinct documents (chemistry, manufacturing and control (CMC) information, benefit/risk analyses, labeling, study reports, etc.). The eCTD specification outlines the types of files that are supported (PDF, RTF, JPEG, etc.), folder structure requirements, naming conventions for files and folders, metadata requirements (such as a table of contents) and stylesheet guidelines. A submission that is structured according to the specification can be viewed using an eCTD viewer or even a standard web browser.
The ICH consists of representatives from the big three regulatory bodies (US, Europe and Japan). So, of course, these agencies are leading the way toward fully electronic interfaces.
- As of January 1, 2008, all marketing applications must be submitted in eCTD format to the FDA. Waivers are available by request.
- From July 1, 2009, the EMEA will strongly recommend eCTD format submissions for all approval routes. Exceptions may be granted by request.
- Japan’s authority (MHLW) accepts eCTD submissions, but adoption has been slow due to unique MHLW requirements for Module 1.
Some other countries, such as Australia and Canada, have also taken steps toward eCTD requirements.
The goal of the move to electronic submissions is to decrease the amount of time it takes for the health authority to review an application and its related lifecycle documents. However, after the first six months of the FDA’s 01-Jan-2008 mandate, results were mixed (see “The eCTD – a Six-Month Checkup” on Bio-IT World.com). The FDA received over 30,000 electronic submissions in the first six months, but many submissions were of poor quality (e.g. missing table of contents, missing Module 1). These mistakes often result in application rejection, which in turn, ends up increasing the amount of time for review.
Things are expected to get better, though. The pharmaceutical companies will get better at electronic submissions (either through building skills in-house or outsourcing) and the tools for authoring eCTD-compliant repositories and managing changes to the application throughout its lifecycle will improve. Electronic submissions are obviously a vast improvement over paper submissions on all fronts. There will be growing pains, but we should see significant positive results before the end of the decade.
If you enjoyed this post, please consider leaving a comment or subscribing to the feed and get future articles delivered to your feed reader.
Loading ...
Comments
No comments yet.
Sorry, the comment form is closed at this time.