Electronic submission benefits
Paper dossier submissions are lengthy and costly:
- The production, storage, handling, review and distribution of a large volume of documents involves considerable costs
- Searching and viewing information in a large amount of paper documents is long and painful
Adopting an electronic format (eCTD, NeeS, vNeeS …) has many advantages:
- Reading documents is easier, most of the documents having been created electronically
- Space saving is substantial thanks to the sheer size of many drug MA dossiers
- It is possible to use an electronic gateway for automatic submission to the authorities, which saves time and eliminates errors during transmission
- It is possible to more easily reuse documents for multiple submissions
Review is easier because:
- It is possible to navigate within and between documents and dossiers
- Several people can view the same document at the same time
- Researching information is easier thanks to indexing and use of a full-text search tool
That results in:
- A significant cost reduction
- An accelerated submission cycle with regulatory authorities, which enables to gain precious months of product sales
eCTD format: quick adoption in the United States
According to the FDA Web site, the percentage of NDA (New Drug Application) in electronic form has increased between 2006 and 2015 from 2.3% to 85%.
Adoption of electronic submission of dossiers for new drugs is rapid in the United States, and mainly in eCTD format.
The European Union does not publish submission statistics, but all indications point to a similar trend in Europe.
FDA and EMA: towards a compulsory eCTD electronic submission
Since 2010, eCTD electronic submission has become mandatory in the European Union for centralized submissions. It is also the preferred method of authorities for mutual recognition, decentralized and national procedures. Some national authorities such as Estonia, Bulgaria and the Czech Republic do not accept paper submissions any more.
The FDA has announced that from 2016, all new drug submissions will have to be made in eCTD format.
eCTD format benefits
The eCTD format is built on recognized standards and has been stable for years. These standards reflect the ICH guidelines. They allow you to submit documents in the United States and Europe with minimal modification effort. This enables to gain months of marketing in areas now representing the largest markets for the drug.
The format allows you to manage the dossier lifecycle, and thus have a complete history of submissions. Interactions are thus facilitated whether they are internal or with supervisory authorities.
Reuse of content is also facilitated, which makes it easier for national submissions.
For smaller companies, subjecting in eCTD facilitates partnerships with leading pharmaceutical companies, as their submission processes are generally already in eCTD.
There are now reliable and effective tools for managing eCTD submissions. This is particularly true of eCTD 247. Such tools facilitate the transition of the company to the eCTD submission format, and help reap the potential benefits of the format.
eCTD benefits for regulatory authorities
Regulatory authorities incur a significant amount of work to address the many submissions made by the drug industry. For example, the FDA must address more than 20,000 requests per month, which represent more than 50 kilometers of paper.
eCTD submission allows them to handle these large volumes more quickly than paper submissions (which take up to three years to be processed), and process much more complete, and therefore better submissions reviews. Indeed, it is possible with eCTD to:
- Quickly find the information through search engines
- Consult submissions faster
- Have several reviewers work simultaneously on submitted documents
- Quickly identify (life cycle management) the new elements in a submission
eCTD also allows authorities to reduce processing costs by automating operations that were heavy and costly with paper (such as physical handling of documents, for example), and save space.
How to reap the benefits from eCTD submission
Leverage this transformation to improve your submission process
Transition to eCTD is a good opportunity to review and improve internal submission processes. For example, it is desirable to analyze the dependencies between these processes, and to reconsider the nature of the content produced by these processes.
Making these processes more adapted to the new electronic way of working, you will release additional efficiencies and diminish costs.
Ensure active support from the management
The transition to electronic submission (eCTD or otherwise) is a project that involves a change management process, and adequate training of company staff to adapt their skills to new tools and development processes.
As with any change project, management involvement and the presence in the C level executives of a project sponsor is essential to ensure its success.
Choose a suitable tool
Various factors must be taken into consideration when selecting an eCTD dossier management tool suited to your needs.
A key aspect is a strong integration of this tool with an EDM solution (Electronic Document Management), which will provide you with you all important possibilities:
- Document life cycle and validation management, for the documents to be included in your submission dossiers and for dossiers themselves
- A full text search engine that allows you to search for documents, including within text documents
- Metadata management, which will allow you to manage your document classification, or create views of selected documents meeting certain criteria
- Document version control and records, which will allow you to ensure that the documents included in dossiers are in the right versions
- Drag and drop of documents from the EDM or from the file management for intuitive use
- Storage and archiving of your documents and dossiers
It is also important to have a tool that manages multiple standards (eCTD, NeeS, vNeeS and CTD paper submissions), as standards evolve, and you may need to manage an existing history of paper submissions, or submit on paper in some cases.
Another important point is the ability to configure the tool to suit your needs without having to commit to IT developments.