eCTD Continues Rise to Global Prominence
The ability to meet standards and regulatory approval is nowhere more important than in the pharmaceutical industry. All companies have responsibilities when it comes to submitting information to authorities in both a precise and proper manner as, otherwise, their latest developments and innovations could be held back by dreaded red tape.
Global leaders in the pharmaceutical world have recognised this issue, which is why an increasing focus has been put on the use of the electronic common technical document (eCTD) system for processing submissions. While the concept has been prominent in the industry for several years, it is likely to be boosted even further in coming years, as it becomes the standardised format used by a number of bodies including the US Food and Drug Administration (FDA).
However, what exactly has led the industry to view eCTD - which was developed by the M2 Expert Working Group in conjunction with the International Conference on Harmonisation (ICH) - as the future of submitting regulatory documents?
According to Peter Derycz, the founding partner of marketing services firm Derycz Scientific, its five-module format that demands information on a range of topics is one reason authorities have taken to it so well.
"The reason this format was chosen is because it is optimised for copying/pasting, viewing/printing, annotating, facilitating the export of information to databases, searching within and across applications and navigating through the document," he outlined in a column for Drug Discovery News.
However, he added that industry leaders have not just chosen the set-up for their own benefit, explaining: "The eCTD format offers an important opportunity to make your company globally relevant, as it is standard across all markets worldwide. A successful pharmaceutical company is a global pharmaceutical company."
So how are firms adapting to using the system? Well, many have turned to software solutions that are designed to specifically deal with the format and design of the submissions. Such dedicated document services designed to deal with eCTD are "a valuable aid", Mr Derycz explained, as it allows companies to process documents either individually or in a group within a couple of hours or so.
His company is one of many that have launched facilities designed to boost the process of using eCTDs. Derycz Scientific's subsidiary Reprints Desk was launched to streamline the process for companies looking to obtain approval from the likes of the FDA (FDA Approval).
Other firms that have taken steps into the world include Datafarm, which recently added the new Vue program to its eCTD solutions suite. According to the company's chief executive officer, Shy Kumar, the technology "was designed to further simplify the regulatory submission process for our customers".
"It's an easy-to-deploy, easy-to-use application that will enable users to view their eCTD submissions regardless of the region for which they were created," he explained. "This product is a must-have for every life science company embarking on national and international regulatory submission processes that use the eCTD submission format."
Last month, solutions provider Extedo also unveiled a new version of its eCTD viewer and validation solution, Gecco. The 1.4.1 version of the program includes full compliance to European Union Module 1 specification, as well as support for validation rules used in Canada. Harv Martens, vice-president for North America and Japan at Extedo, said the service is "the most accurate and current" viewer of its kind on the market.
He added: "Gecco rules are distilled from current ICH specifications, ICH and agency Q&As, regional specifications, guidance documents, best practices and a healthy dose of good judgment based on many years of experience."
The concept of eCTD is expected to become the preferred format for drug applications and submissions across the globe towards the end of this year, so the importance of the latest solutions and software available in relation to the issue is likely to grow in the coming months.
However, it is clear that the rising prominence of this form of submission has been driven by the benefits which a standardised system offers not only to the recipient authorities, but to the firms sending them. It appears that eCTD is only likely to become a bigger issue in the near future, so companies need to ensure they have prepared fully for its use.
Getting eCTD Submissions Right
Ensuring eCTD readiness is now critical for gaining first time market approval. Dr Klaus Menges from the Division of Strategy and Planning, at the Federal... listen now