eCTD Rises in Popularity Across Europe

Pharma IQ

As a growing number of industry authorities confirm that they only intend to accept documents for approval in electronic form, the concept of the electronic common technical document (eCTD) has risen in prominence.

Although its impact was first felt in the US, when the country's Food and Drug Administration endorsed it as the standard form of application, the effect of electronic submissions in the eCTD format is increasingly being felt across the globe. The last few months have shown how several regions are adopting the solutions, as well as how many software providers are benefiting from the growing interest.

Regulatory affairs solutions provider Extedo announced that new eCTD specifications published by Croatia's regulatory authority Halmed are support by several of its products. Image Solutions, a leading developer of submissions solutions and consultancy services for life science companies, also recently revealed the number of countries that have updated requirements in relation to eCTDs.

Finnish regulatory agency Fimea started accepting electronic submissions with reduced paper requirements from June 1st, with the intention of switching to all eCTD or non-eCTD electronic submissions from the start of next year. In addition, Germany is now facing an electronic-only future, while Poland has been accepting such submissions since the start of this year.

Switzerland looks set to join that group, as Swissmedic - the supervisory authority for therapeutic products - recently published the next official phase of eCTD specifications and guidelines to be put into force in the country. Kate Wilber, director of consulting services in Europe for submissions management firm ISI, said adoption of the eCTD format is already accepted in the area due to its advantages.

"Most organisations are now well on their way to embracing eCTD, both for local compliance reasons and because they appreciate the strategic advantage of being able to reduce their time to market, while increasing internal efficiency and accuracy," she explained.

ISI recently launched its new Regulatory Solutions Suite, which is designed to help Swiss firms as they get used to eCTD. The organisation has revealed that the solution includes functionality to address the growing use of the format in Switzerland, as well as a roadmap to take into account new requirements as they are released by Swissmedic.

Wilber said: "Switzerland's growing focus on eCTD presents an opportunity for companies to leverage eCTD in yet another market, while continuing to leverage their existing working practices for eCTD management in other markets," she continued. "After all, one of the greatest efficiency gains associated with electronic submissions comes from the ability to re-use approved dossiers, and to build efficient business processes."

While ISI's new suite may be focused on the Swiss market, the fact that the software can also be used in line with eCTD regulations in many other countries across the world - including Australia, Japan and the US - shows how the concept has gone global in recent years. The continuing adoption of eCTD in such countries proves that drug development firms could be left behind by not fully considering how they should adopt technological solutions which support the format.

Expertise in the area is slowly becoming an essential aspect of moving forward in the pharmaceutical sector, so organisations should be looking intently at all the ways they can push forward to embrace the benefits of eCTD and prime their operations for a successful future.