In a day and age where more and more communication happens without putting pen to paper, it is no surprise that eCTD submissions are fast becoming the way for the pharmaceutical industry to transfer regulatory information to the relevant health authority. Paper documents often require lengthy and painful searching to collate and extract data, and then there is also the matter of the vast storage needs.
Companies offer outsourcing solutions for e-submission services and eCTD solutions to ensure successful and timely submissions for your applications. This could be something to consider as you can benefit from expert advice every step of the way.
A brief history
Since 2010, eCTD electronic submissions for new drug applications have become mandatory in the European Union for centralised submissions. eCTD compliance is becoming increasingly adopted as a best practice worldwide, and countries such as the Czech Republic and Bulgaria have ceased accepting paper submissions for national procedures.
Benefits of electronic submission
There are many benefits of submission via eCTD. With this in mind, we have focused on the benefits for businesses involved with applications, submissions and reports in the drug development space.
- The software uses managed document environments via an environment developed by qualified staff
- Document reading is more straightforward through electronic creation
- More accessible and less time-consuming reuse of documents for further submissions
- Reduces replication errors
- Transmission and delivery issues are reduced by using an electronic gateway for automatic submissions
In more detail
Indexing and text search functions simplify locating information for research and checking purposes. It’s possible to navigate between dossiers and documents quickly, and with several people able to view the document simultaneously, it can save time and repetition of the same work. These benefits bring cost savings and accelerate the submission cycle, which speeds up the process and can significantly increase the time to bring drugs to market, and therefore sales begin sooner.
eCTD standard formats
Standard eCTD formatting has been in place for many years. The use of recognised standards and their reflection of the ICH guidelines means applications to multiple countries, including Europe and the United States, can be achieved with minimal modification requirements. This makes it easier to bring drugs to market and gain time marketing in areas with the greatest demand for the drug.
eCTD submissions also make it easier to manage the dossier lifecycle and maintain a complete submission history for all applications, to facilitate internal and supervisory interactions more readily. National submissions are more straightforward by reusing existing submission data, and smaller companies can more readily partner with leading pharmaceutical partnerships if they adopt eCTD submissions.
Faster processing for regulatory authorities
Regulatory authorities are now far less bogged down by the sheer volume of paper from the many thousands of submissions made by the drug industry each month. eCTD submission can significantly reduce the time to handle large volumes and make decisions more speedily. They can automate and remove many of the more costly handling and storage processes previously required.
Better submission reviews are possible with the ability to quickly find information through search engines and allow more reviewers to work simultaneously on submitted documents. One of the most significant advantages is following life cycle management and quickly identifying new elements in submissions.
How to reap eCTD submission benefits
Making your processes adapt to the eCTD submission electronic way of working provides opportunities to improve internal submission procedures. Analyse the dependencies between the methods and look again at the content produced. eCTD adoption will help you benefit from reduced administration and paper storage costs and release additional efficiencies within existing workforces.
Suppose you are looking to begin an eCTD journey. It might be wise to seek expert help to understand best practices and navigational aid for the eCTD lifecycle, including submission strategies, timelines, reviews, submission hosting, and importing and cloning of existing applications. That way, you can ensure all the relevant boxes are ticked, and you can reap the benefits of this method of submission.