The eCTD is comprised of 5 modules, each of which has its own requirements in terms of documents and content.
The benefits of eCTD include:
- eCTD has become a mandatory format requirement for many regulatory health authorities; Europe, the US, Canada, Switzerland, Australia, GCC, South Africa, Japan, Thailand and Jordan and many other health agencies are accepting eCTD as a standard.
- XML backbone (replaces CTD table of Contents)
- Cloning of submissions means simultaneous global submissions
- Easier and more efficient to review, search, copy and paste for reviewers to navigate through the eCTD application
- Lifecycle tracking of documents of replacing, append or delete which reviewing health authorities can easily track.
- Hyperlinking to documents submitted in previous submissions.
- Cross-referencing to other eCTD applications
- the ability to efficiently organise, prepare and manage submission content
- Multiple people can review submissions simultaneously
- Only submit updated / new files
- Most importantly, meeting regulatory health authorities’ deadlines
The financial benefits associated with eCTD submissions:
- A faster review and time to market
- Lower cost of production and storage (no paper wastage)
- work efficiency increased significantly, as regulatory authority reviewers can search data easily, communication is quicker
In-house publishing vs. outsourcing?
- In-house system: Publishing systems require investment in IT infrastructure and personnel
- Vendor selection process
- How many eCTD Software licenses and eCTD validation tools
- Costs for system maintenance (frequently underestimated the time required), personnel, costs and periodic upgrading and revalidation.
- Training of team (SOPs, user/training manuals)
- Learning on the job, possible risk to timeline, quality and understanding of requirements
- Costs can be high for an organisation with a small number of applications
- High level of expertise
- Always meet tight Agency deadlines
- Added significant value to the internal team
- Flexibility Client decides to outsource certain types of work
- Outsourcing company have optimised their eCTD working practice through long practice experience and to a high-quality standard.
- No software and hardware requirements/costs
- Costs arise for actual projects
- The outsourcing partner guides the client through regulatory and formal eCTD requirements.
- Provide other services
Reasons to Outsource
- It is key that the company submit the initial application on time and with no technical validation issue
- No in house experience, No software training
- No dedicated team for this work
- The client can focus on drug development, content writing and not on the technical aspects of eCTD and the worry about submitting to the regulatory authorities
Is eCTD right for you?
If the events of the last couple of years have shown us anything, it is that those companies who are not taking advantage of all of the technology tools at their disposal can all too quickly fall behind, leaving their competitors with a distinct advantage. We must ensure that we are ready for whatever comes along, fully prepared.
Companies worldwide already include the eCTD in their global submission strategies. They understand that if they want to stay ahead of their competitors and ensure that all of their eCTD requirements are fully up-to-date, this is the best and the only way forward for the future of their companies. eCTD makes sense on so many levels. It is better for the companies involved and can make things so much easier for those who need to check this documentation.
Let ONIX take the worry out of your eCTD submissions to allow you to focus on drug development.