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The eCTD (electronic Common Technical Document) structure was put together to help align the submission processes surrounding the required regulatory reviews conducted for global drug development. The process’s structure comes from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
The electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of content is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. An eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the file’s integrity guaranteed by the MD5 Checksum.
eCTD Submissions to regulatory health authorities
The eCTD is the standard format for submitting applications to many regulatory health authorities.
FDA: As of May 2017, the eCTD structure is the only acceptable form of submission for ANDAs, NDAs and BLAs. This was amended in May 2018, and INDs were added to the list of those submissions that need to be made following the approved eCTD structure.
EMA: The eCTD format is mandatory to use for all submission types related to Marketing Authorisation for products within all EU procedures (i.e. Centralised, Decentralised and Mutual Recognition Procedures).
What are the advantages of the structure?
There are five distinct categories to the CTD. Each of these carries its requirements when it comes to documents and content. The advantages are:
- Those who review the submissions are familiar with the standards applied to both content and documentation
- It is possible to look at updates in real-time
- eCTD structure helps to speed up the review process by the regulatory authorities, leading to faster approval
- Managing, handling and archiving documents and essential trial information takes up less time
- Documents need to be easily accessible so that they might be easy to track and search
- There is a minimisation of duplicated or missing documentation.
The challenges that come with the eCTD structure
Larger companies are better equipped to implement eCTD fully when it comes to their submissions. They have the infrastructure, team and budget to be able to implement eCTD completely and efficiently. However, smaller companies may not have the same resources and may struggle to implement eCTD fully. This can be a disadvantage when submitting documents and trying to meet deadlines.
When it comes to preparing your eCTD submission, there must be full coordination of documentation. Challenges can arise along the way when there are limited resources available in the process.
When preparing your submission, it is, therefore, essential to ensure that you avoid the following three obstacles:
- establish a clear and concise communication plan from the start. This plan should include who is responsible for each task, the deadlines, and how progress will be monitored. By having a clear plan in place, everyone involved will know what is expected of them and can work together to ensure a successful submission.
- Documents must be formatted correctly in order to be accepted. This means using the proper document template, including all required information, and following the submission guidelines.
- Ensure to include all required documents in order to be accepted.
#1 Making the transition from paper to eCTD
It is now required that every organisation use the electronic format for their submissions. In addition, smaller companies who may be at several different stages of their submission planning need to ensure that any paper documentation is converted to a digital format.
This is transitioning from one format to another is a significant undertaking for companies to their resources.
#2 Ensure that submission readiness is achieved
Companies need cutting-edge tools if they are going to make a move to an electronic platform successfully. These tools include:
- eCTD publishing software
- ESG’s (Electronic Submission Gateway) setup
- Viewing software
Each tool needs selection, validation, setup, compatibility checks, maintenance, training, and software upgrades.
#3 Follow directives and guidance for submission success.
Whilst there are several directives from the ICH, and each regulatory authority (FDA and EMA) is in place, there is still a chance that mishandling and errors will occur, leading to a submission being rejected.
Reasons that a rejection could be made include:
- Files are missing or security on files
- The use of sequence numbers that are duplicated
- Not conforming to the published FDA and EMA validation criteria.
The rules are complex, and for those companies with no technical expertise in-house, outside support companies are there to help, so it can be a good idea to consider using one to ensure full compliance with your eCTD submissions.
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