The story of the electronic Common Technical Document (eCTD) began in 2003 with the clear objective of establishing a worldwide standard for electronic submissions. Fifteen years later, eCTD has become the de-facto standard for submissions throughout the industry and across the globe.
Being the electronic equivalent to the Common Technical Document (CTD) Format, eCTD was designed as an interface for the industry-to-agency transfer of regulatory information. At the same time, it facilitates the creation, lifecycle management, and archiving of electronic submissions. The standard itself was developed by the International Conference on Harmonization (ICH) and defined the criteria that make an electronic submission technically valid.
Where the eCTD standard is used
The eCTD standard is now used extensively in Europe, the USA, the GCC countries, and many other countries such as Australia, Canada, China, Japan, South Africa, etc. The eCTD standard is also planned by other regulatory authorities such as Brazil, Israel, and Tanzania. In addition, other regulatory authorities, such as in India, Mexico, or South Korea, are thinking about adopting the eCTD standard. As this roll-out continues, organizations need to prepare themselves for the new way of working. This will mean additional effort in the short term, but by ensuring that processes and software are updated and optimized, businesses can best take advantage of the opportunities eCTD provides.
eCTD is not a new standard, and many companies have been through the process of rolling it out before. Undoubtedly there will be challenges as you move through your implementation, but the opportunity is there for every organization to achieve operational excellence throughout their business. Learn from the mistakes of others, and above all, don't be afraid to ask for help from the experts.
The eCTD standard is accepted or even required by regulators in many countries. Further information on the national version of the eCTD standard is often provided on the websites of the respective authorities. We have compiled a corresponding list for you in a separate blog post.
If you are looking for an effective tool to comply submissions with regulatory standards and processes around the world, you can learn more about EXTEDO's eCTDmanager - the comprehensive solution to manage, publish and validate your regulatory submissions. Well-known companies from the life sciences already rely on eCTDmanager. To learn how we implement these projects and how our customers now rely on effortless compliance, download one of our case studies right now.
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