Why eCTD 4.0 is essential
The electronic Common Technical Document (eCTD) is a standardized format for submitting regulatory information to health authorities. Initially implemented using XML-based index files and PDF documents, eCTD streamlines the electronic filing of submissions, ensuring consistency and efficiency in regulatory processes. Despite early challenges, the eCTD format has become the primary expected submission format.
eCTD 4.0 is the latest version and an advancement in the submission of regulatory information for pharmaceuticals to health authorities. Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), eCTD supports the structured submission of data required for the approval of new drugs and the maintenance of regulatory information throughout the drug lifecycle. It replaces the previous version, eCTD 3.2.2, with enhanced features and capabilities.
Characteristics of eCTD 4.0
Staying compliant is crucial. On top of that, upgrading to eCTD 4.0 offers several additional advantages.
Enhanced lifecycle capabilities
eCTD 4.0 supports a more comprehensive approach to lifecycle management as it handles content changes more flexibly.
Effortless metadata correction
In eCTD 4.0, keywords are crucial for organizing similar information such as product details, substances, and manufacturers. It allows for easy correction of typos, simplifying the maintenance and accuracy of your eCTD submissions whenever adjustments to metadata are required.
Greater flexibility
eCTD 4.0 supports more flexible submission structure updates. These updates are maintained via Controlled Vocabularies.
Document reuse
eCTD 4.0 enables the one-time submission of a document to a Regulatory Authority, allowing for its unique identifier to be referenced in future submissions. This can streamline submission creation as well as submission reviewing.
LORENZ Life Sciences Group - the pioneer in e-regulatory solutions
For over 30 years, LORENZ has been a key player in the Life Sciences market. Our history is closely intertwined with the creation and development of the eCTD and the digitization of regulatory affairs. Since 1989, LORENZ pioneered the creation of the first official standards (DAMOS) for electronically submitting documents from the industry to the authorities. From these early beginnings, LORENZ has remained at the forefront of the industry, playing a critical role in being the first to file in the new electronic standard for the Common Technical Document – commonly known as the eCTD. Click the link below to read the full story of how we built the world's first electronic submission solution.
Easy eCTD 4.0 implementation with LORENZ RIM Solution
For many organizations, transitioning to a new standard can be daunting, often involving costly software upgrades and extensive training programs. With our cutting-edge Regulatory Information Management (RIM) software, including LORENZ docuBridge and LORENZ drugTrack, these concerns become a thing of the past. With LORENZ, transitioning to eCTD 4.0 is seamless as our format-independent solution allows for easy implementation of any future format. We see eCTD 4.0 not only as a regulatory requirement, but also as an opportunity to enhance your regulatory operations with a partner who understands your needs.
Why choose LORENZ Life Sciences Group
Effortless updates
Upgrade to eCTD 4.0 seamlessly – no need for new software or extensive training and hours of webinars.
Proven reliability
Rely on solutions developed by industry pioneers with over 30 years of experience in regulatory standards.
Comprehensive support
Enjoy dedicated support from our expert team to ensure a smooth transition.
Looking for an easy answer? We are at your service.
For LORENZ, eCTD 4.0 means implementing just another format into our service, as we have done over the past decades.
A trusted partner for industry and agency
Trusted by the best
Leading regulatory agencies around the world rely on LORENZ's RIM solution. Our ecosystem includes 19 key agencies, such as BfArM in Germany, UK MHRA, Health Canada, and the US FDA.
Leadership in eCTD 4.0
LORENZ is at the forefront of eCTD 4.0 development. Since 2022, we've partnered with the FDA to offer our clients exclusive access to a pilot testing environment. Our customers were enabled through dedicated, cloud-based pilot systems, allowing them to test the latest version of eCTD 4.0 in a secure and even private environment. We monitored and implemented all necessary updates. A tailored training module specifically designed for eCTD 4.0 was also provided by our expert trainers.
Proven expertise
Since pioneering e-regulatory solutions in 1989 LORENZ has delivered over 1800 successful installations across 48 countries. From small enterprises to the largest global pharmaceutical companies, our clients trust us for unparalleled regulatory expertise.
Prepare for the future – embrace eCTD 4.0 with LORENZ
As the next evolution of the established eCTD format, eCTD 4.0 will soon become a mandatory standard for regulatory submissions in some countries. Agencies are already announcing timelines for its adoption, signaling a shift that will impact regulatory practices worldwide.
At LORENZ, we are committed to guiding our customers through this transition. We advise taking action on eCTD 4.0 now to stay ahead of the curve and ensure compliance with upcoming regulations.
Upcoming mandates
Agencies are setting clear deadlines for eCTD 4.0 implementation. Staying proactive will position you favorably as these deadlines approach.
Strategic advantage
Investing in eCTD 4.0 now ensures you are prepared for the future, minimizing disruptions and maximizing your competitive edge.
Current Adoption Timeline
Review the upcoming mandatory adoption dates for eCTD 4.0 in key markets.
Ready to take the next step
Allow LORENZ help you navigate this transition seamlessly. Contact us today to learn how our solutions can support your eCTD 4.0 strategy.
Explore the future of regulatory submissions with LORENZ
Introducing Dynamic Submission Management (DSM)
As eCTD 4.0 sets the stage for the next standard in regulatory submissions, LORENZ is shaping the future with innovative solutions. Our "Dynamic Submission Management" concept offers a comprehensive look at how regulatory processes are evolving. Get an in-depth analysis and discover historical trends, current challenges, and emerging solutions that are redefining submission management.
Watch the expert video for an in-depth discussion on the evolving landscape of regulatory affairs.
Stay compliant, stay confident!
Don't miss out on critical updates in eCTD 4.0 and the world of regulatory affairs. At LORENZ, we keep you at the forefront of industry developments.
Timely updates
Be the first to know about the latest trends and changes in regulatory standards.
Exclusive content
Access podcasts, regulatory updates, free webinars, and expert insights tailored to your needs.
Sign up for your LORENZ ID to stay informed and confident in your regulatory strategy.