Momentum towards mainstream adoption of the electronic common technical document (eCTD) standard for drug application submissions is growing in Switzerland, following publication of formal, updated guidelines by the Swiss Health Authority.
Swissmedic, the central Swiss supervisory authority for therapeutic products, has now published the next official phase (version 1.1) of the Swiss eCTD specifications and guidelines, on its eSubmission website. This contains all necessary adaptations for the future submission of variations, master files and submissions, and will apply to electronic-only submissions in eCTD format as of July 1 this year. (A transition period for technical implementation has been designated until January 2011.)
Switzerland’s growing momentum towards eCTD adoption further strengthens the business case for proactively embracing formal electronic submissions as a strategic approach to submissions. Says Kate Wilber, Director of Consulting Services, Europe, at international submissions management specialist ISI (ISI): “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.”
“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. 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.”
The latest release of ISI’s Regulatory Solutions Suite of submissions management and publishing software includes specific functionality addressing the step-wise adoption of eCTD in Switzerland, with a defined roadmap to address new and ongoing requirements as these are released by Swissmedic.
ISI RSS is a comprehensive product suite comprising multiple integrated software modules that address the specific publishing needs of any pharma corporation. They provide the functionality to create any submission format (eCTD, NeeS, ACTD and paper), while ensuring compliance with evolving country-specific guidelines, accelerating companies’ time to market.
Individual applications in the suite include eCTDXPress, for compiling, creating, publishing and managing electronic submissions in the eCTD format; ISIPublisher, enabling companies to seamlessly publish all the regulatory documentation required in a paper or non-eCTD submission; Virtual Link Manager (VLM), for efficient management of hyperlinks and bookmarks; and ISI Toolbox and ISIWriter Templates – complementary productivity tools and templates that simplify and streamline workflow and extend the reach of the information contained in submission systems.
The ISI suite also caters for the varying needs of other European and International markets, meeting the latest requirements for both electronic and paper submissions in Australia, Japan, European Union and emerging countries such as China, India and Russia, as well as well established eCTD criteria in the US and Canada. ISI also provides regulatory consulting and process-based services.
Switzerland isn’t the only European country to have published updated requirements recently. Fimea, the Finnish regulatory agency, began accepting electronic submissions with reduced paper requirements from June 1 and will require electronic submissions (NeeS or eCTD) from January 1, 2011. Germany is also now accepting electronic-only submissions, as of March, while Poland has also been accepting eCTD since the start of this year.
• The latest issue of the ISI publication, Sentinel, provides a full update on the latest submissions requirements in Switzerland. This can be downloaded from the ISI website.
• To find out more about ISI and its regulatory solutions, visit imagesolutions.com/solutions.html
Swissmedic (swissmedic.ch) is the central Swiss supervisory authority for therapeutic products. It is a public service organisation of the federal government with headquarters in Bern. While independent, Swissmedic is linked to the Federal Department of Home Affairs (FDHA).
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.