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The challenge

Using the Non-eCTD electronic Submission (NeeS) format, regulatory information must be structured in accordance with the CTD, which in paper format became mandatory in the EU in 2003. For the NeeS application itself, the eCTD structure is used and document granularity should follow the respective ICH and regional guidance. Filenames are specified via ICH and regional file naming conventions and should be followed closely to avoid later technical validation errors.

From the dossier structure point of view, a typical NeeS dossier would cover multiple dosage forms and strengths of a particular product with one invented name. Once submitted, it is recommended to use the same structure for subsequent submissions.

Compared to the eCTD, NeeS is still lacking the XML table of contents (the backbone), electronic meta data and the MD5 security, which ensures that the document package is complete and intact. Moreover, the NeeS format does not support any type of defined document life cycle compared to the eCTD, making reuse of already submitted information more complex.

One of the differences between eCTD and NeeS is navigation. NeeS does not offer the benefits of navigating via the XML backbone. Instead, electronic tables of contents for the entire dossier and on a module by module basis are used, together with document bookmarks and hyperlinks created during a review process.

One of the clear disadvantages of NeeS is data protection. Compared to eCTD, which is protected by multiple MD5 checksums, NeeS does not offer any such security.

The solution

Samarind RMS caters for the NeeS formats in the same way as it offers support for eCTD. Documents are stored in a secure controlled environment and any changes are logged, giving our customers confidence in that the information compiled is secure and accurate. NeeS dossiers will be compiled in the same way as eCTD dossiers by simply dragging and dropping documents into the structure.

The benefits

Using Samarind RMS for compiling and managing NeeS submissions could not be easier and comes with many advantages.

  • Secure storage for all documents in an easy-to-manage, quick-to-learn environment
  • Ability to allocate documents to products, submissions or licences, simplifying dossier compilation
  • Readymade templates allowing authors to concentrate on content rather than format
  • Automated PDF renditioning without the need for additional software, ensuring (technical) consistency throughout the dossier to assist submission review and assessment
  • Simple NeeS structure creation reaping the benefits of the Emerging Dossier Concept
  • Automated creation of the required table of contents.

Creating the final NeeS output is simple and fast as all documents are stored in the same repository.

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