Challenges in eCTD Publishing & Submission Management

Challenges in Regulatory Publishing and Submission Management

Electronic regulatory publishing and submissions originated in the late 1980s and have progressed considerably in the last few years, particularly in key markets. The transition from paper-based submissions to electronic submissions has transformed the management and transfer of regulatory information, leading to reviews on a more efficient basis and improving the lifecycle management of submissions. In 2003, ICH ratified a milestone of the Electronic Common Technical Document (eCTD) v 3.0 guideline as an internationally accepted structure and format for electronic regulatory publishing and submissions in UAE, which provides benefits such as ease of workability, data transparency, and ease of facilitating the transfer of information typical between sponsors and regulatory submission publishing in UAE. Today, most agencies have supported the CTD structure and active encouragement toward moving from CTD to eCTD. 

Understanding eCTD requirements for your effective and successful use for regulatory publishing and submissions is very important. However, these requirements are not always clear and issues may arise if you do not follow accepted eCTD standards. If this happens, sponsors may need to make last-minute adjustments that jeopardize timelines or worse, there is a possibility of the file being technically rejected as a whole.

Here are a few of the more common issues that arise when documents are submitted in eCTD: Issues related to the documents’ clarity in the submission is common for documents to be:

• Manual bookmarking

Bookmarks are essential components for smooth navigation within the dossier. However, bookmarking, and hyperlinking tasks are repetitive and time-consuming, which can cause delays in review processes and eCTD submission.

•  Hyperlinking issues

A common issue that publishers face is broken or invalid links because the section does not exist and cannot be linked. 

•  Large-size file upload

Publishing and submitting large-size files to the submission portal while adhering to stringent agency timelines can be a challenge. Many agency portals have a file size limit and/or do not accept multiple submissions for a single application.

•  UUID validation error

Repeated UUIDs for documents in the dossier can lead to validation errors and can result in rejection by Agencies.

• Managing product lifecycle

One of the biggest barriers to the eCTD right now is managing all of a product’s lifecycle records. The strict eCTD structure, which offers little leverage in the product lifecycle and metadata, is one of the greatest drawbacks. 

Other challenges in regulatory publishing and submissions include (but are not limited to) differences between regions in hyperlinking, bookmarking, and PDF file versions; reliance on contemporary technology and staff; changing late in the submission part; varied region validation rules and authentication; substantive granularity; and bad versioning. In summation, the standardised publication method is now a requirement in the largest markets in eCTD format.

Therefore, it is now vital for companies to have a cohesive platform that favors the lifecycle of any kind of embedded submission because they will need to control a complicated cycle of compiling, accumulating, publishing, and documenting various new drug / medical device applications. However, companies often do not have such platforms, prefer and still depend on antiquated and slow paper-based processes that use up both time and money. Lifesciences companies must have all documents, including answers to enquiries, updates, and restoration in a consistent electronic format to complete the eCTD submission.