The move from CTD to eCTD in Egypt is approaching. To support preparations, Extedo hosted an eCTDmanager Demo with Dr. Asmaa Khalil El-Kersh (Boston Biopharma), Nicole Sagner (EXTEDO), and Dr. Ayman Elbishbishi (DAF). The session covered CTD/NeeS/eCTD fundamentals, building an eCTD sequence in eCTDmanager (envelope info, custom attributes, dossier documents), compilation and publishing with validation/reporting, and an introduction to DAF.
Below you can find questions raised during the webinar and corresponding responses.
Key Takeaways
- Timeline: eCTD accepted from Q3/2025; mandatory January 2026 (for new pharmaceutical registrations). An update from the authority is expected; official timelines will be published via EDA, EXTEDO, and DAF channels.
For the general eCTD context, see ICH M8, eCTD v3.2.2.
- Scope: Initial implementation applies to new pharmaceutical submissions.
- Portal & sending: After creation and publishing of a submission, upload the zipped package to the EDA portal. The portal is browser-based and accessible from abroad. Further details will be published by the EDA.
Egypt’s public CTD guidance provides dossier-structure context: EDA CTD guidance (PDF)
- How EXTEDO helps: Commercial RSTs for single countries and regions; eCTD structure templates available in the solution; optional eCTD templates for authoring.
See: Submission Publishing, eCTDtemplates.
- Lifecycle & PDFs: Reuse documents; link across sequences; hyperlinks/bookmarks do not cause validation errors; broken hyperlinks are removed during export.
- Training: In-person trainings and eLearnings for self-study are available after purchase and implementation.
1. Is it known when EDA plans to implement eCTD, and are the eCTD specifications and validation criteria already ready?
The latest information is:
Nevertheless, we are expecting an update soon. Once the official timelines are announced, it is planned that this will be published on the EDA, EXTEDO, and DAF official communication channels.
For context on the eCTD format itself, see ICH M8
2. Is eCTD implemented in Egypt from Jan 2026 for all product types (Pharmaceuticals, Biologicals, Vet, …)?
eCTD in Egypt will initially be implemented for new pharmaceutical submissions.
It is planned that official information will be published on the EDA, EXTEDO, and DAF official communication channels.
(For dossier-structure background, see EDA CTD guidance (PDF).)
3. Will there be an eCTD portal for electronic submissions in Egypt? Will it be possible to submit from abroad?
It will be possible to upload electronic dossier submissions via the EDA portal, which is browser-based and therefore also accessible from abroad. It is planned that official information will be published by the EDA's official communication channels.
(Check for updates on the EDA website.)
4. How will it go to the regulatory authority portal after publishing the dossier through the software? Meaning, how will it be integrated with the regulator from our software?
After the creation and publishing of a submission, it must be uploaded to the portal in a zipped format. It is planned that official information will be published by the EDA's official communication channels.
(Format standards reference: eCTD v3.2.2.)
5. If, for instance, we purchase EXTEDO for Egyptian eCTD, then what if we need it for other regulatory authorities?
EXTEDO offers commercial RSTs (Regulatory Standards) for single countries and for regions. Feel free to connect with your dedicated account manager to verify the options for your specific use case.
Learn more: Submission Publishing.
6. Do we have to prepare eCTD templates for different countries in EXTEDO?
The eCTD structure templates for different regions are commercially available in our solution. There is nothing that users must create or maintain themselves.
The eCTD document templates that you use to create documents for your eCTD submission can be internal ones, created and maintained by your organization, as long as they comply with eCTD requirements. Nevertheless, EXTEDO also offers eCTDtemplates to simplify the authoring of compliant submission documents.
Links: eCTDmanager flyer (PDF)
7. Is there any functionality to reuse the submitted document in new sequences?
Documents from previous submission sequences are not lost; they are and stay part of your dossier (unless you delete them). They are not published in any new sequence as in new (lifecycle) sequences; only added, appended, or replaced documents (and metadata) are published.
8. Can you link to documents submitted in previous sequences?
Yes, EXTEDO’s submission tool allows new documents in a new submission sequence can be linked to a document from a previous sequence.
9. Are the hyperlinks or bookmarks in the original PDF causing some validation errors?
No, hyperlinks or bookmarks from the original PDFs are not causing any validation errors when used in an electronic submission. In case bookmarks or hyperlinks are available in external documents, they can be imported into the system. In case a hyperlink would be broken (which can happen when a document with a source hyperlink is uploaded, but the target document is missing), the EXTEDO submission tool removes those so-called ‘broken hyperlinks’ during the submission export, and therefore no validation issues are caused.
Product overview: Submission Publishing.
10. Is there an online demo version to train by myself? / Does EXTEDO offer training programs on eCTD submission where I can try submitting/creating a submission myself?
EXTEDO offers several training options when the publishing software is purchased and implemented. Besides in-person trainings, Extedo offers learning for “self-study”, which can be accessed online. This allows you, as a user, to follow your own pace during the functionality training.
11. What is the vNeeS format?
vNeeS stands for Veterinary Non-eCTD Electronic Submission. It’s a structured electronic format used for submitting documents related to veterinary medicinal products to the European Medicines Agency (EMA) and national competent authorities in the EU. Essentially, it’s the electronic way to submit applications, variations, and other documents for veterinary medicines instead of using paper-based submissions.
Reference: EMA Vet eSubmission.
Still have a question we didn’t cover?
Send it to info@extedo.com. We’re happy to support you.
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