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What to Consider When Submitting An eCTD Application

Electronic common technical documents, more commonly referred to as eCTD, are often a complex area that fails for reasons that go beyond simple submission mistakes.

Ensuring your electronic documentation is in good order requires time and constant refreshing of knowledge if you don’t want to be caught out on a technicality.

What are eCTD applications?

eCTD applications are used by many countries worldwide as the standard to submit regulatory information online. It is now mandatory for some submissions and includes drug applications, supplements and reports to relevant health authorities. Thus, removing the need for paper-based submissions to improve the exchange of information with regulators and introduce a consistent format to document compliance.

eCTD consultancy ONIX, a leading name in eCTD outsourcing, offers us an insight into the most common mistakes they come across when working with companies seeking to submit an eCTD application. Before submitting, here are the top things to pay attention to if you want to ensure that your eCTD passes without a hiccup.

Timing

The first thing to do is notify your agency of an expected submission. This will ensure you know the submission timings you must meet for them to consider, thus leaving you sufficient time to perfect your application.

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Register with the relevant agency’s portal or gateway in good time, so you are ready to go when your eCTD application is finalized and certainly in plenty of time before submission deadlines.

Validation

Once you have an agency agreement and know the deadlines, it’s essential to ensure your eCTD submission will pass technical validation before submitting online to the agency. The agency systems will not accept the eCTD submission if the technical validation fails, and no review can begin.

This responsibility falls to your submission partner, and they will manage validation to ensure that your submission is valid. Hence, it’s essential to choose your outsourcing partner carefully, as your application relies on them.

Fillable Forms

Have you got the latest electronic administrative forms? Ensure you use the latest EMA and FDA forms to ensure that all electronic documents pass without flagging errors.

PDF specifications

Each document must align with the relevant agencies’ current PDF specifications regarding content placement and be placed in specific locations within the eCTD structure. Choosing an outsourcing agency with plug-ins that ensure these prerequisites are adhered to makes good sense.

Bookmarking and Hyperlinks

The most critical yet time-consuming task of hyperlinking must be carried out correctly. Resolving missing or incomplete bookmarks and hyperlink issues can be eased with templates that automate referencing and internal linking of internal documents. Your submission publisher or consultant should handle external linking.

Metadata

Validation issues are flagged when metadata is missing, so your submission partner may seem like they are constantly asking about details about the submission. The submission number, type, and description are just some of the metadata fields that frequently cause issues.

Lifecycle operators

Using operators including ‘new’, ‘delete’, and ‘replace’ correctly is essential for updating files within an eCTD application. The improper use of lifecycle operators can leave fields remaining that are no longer valid in addition to the new information added. The latest version could contain both, not the best impression to give the reviewer and certainly leaving you open to problems identifying the most up-to-date and correct information, especially as these errors tend to compound over time and version.

Our Conclusion

It’s great to be confident you have all the areas sufficiently covered, but as you can see, it’s easy to make and compound simple errors throughout the eCTD process. It requires expertise to ensure that you don’t cause unnecessary delays and costs for your business if you stumble on any of the above areas.

It is always in your best interest to partner with an eCTD submission partner who has experience in the process. From identifying strategy, understanding and meeting submission timelines and technical validation and review services, and a complete eCTD lifecycle project management to both new and cloning for existing eCTD applications could ensure you aren’t caught out.

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