On 13 November 2023, the WHO publicly announced the current timelines for introducing the electronic Common Technical Document (eCTD) format. Companies will have the possibility to submit their applications in eCTD once the new ePQS Portal is live.
The eCTD, developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), provides a standardized electronic format for regulatory submissions, enhancing efficiency and consistency in the exchange of information between the industry and regulatory agencies.
The WHO thus follows the example of numerous international health authorities, such as the European Medicines Agency. Companies would do well to use the remaining time for a thorough preparation of the upcoming eCTD submissions to remain compliant.
The ePQS Portal – Your Door to eCTD
By launching the ePQS Portal, the World Health Organisation (WHO) reaches another milestone in the digitalization and streamlining of business processes. Users have the possibility to…
- Access Salesforce records tailored to their needs
- Turn in applications effortlessly
- Safely upload and retrieve documents
- Stay informed by tracking notifications for pending activities
But that's not all: with the ePQS portal, the WHO is also creating the option of submitting applications in eCTD. With the Go Live in Phase 1, this is still merely an option - e.g., for new products, - until it is expected to become mandatory for numerous submissions in 2026.
eCTD – The Transition Timeline
Regarding the timeline published by WHO, we are currently in Phase 0 of the eCTD introduction process. The upcoming Phase 1 will be entered in 2024 and will come with the possibility of submitting submissions for new products. With Phase 2, commencing 2025, the submission of new products in eCTD format.
Please note that these timelines can still be subject to changes or can be specified in detail, as WHO announced in an exclusive webinar jointly hosted by EXTEDO and WHO at the end of November 2023. For a definitive timeline, we recommend visiting the respective WHO landing page.
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Phase
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APIMF/API-PQ Products | FFP Products | FVP Products
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Phase 0
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Companies should take time to familiarize themselves with WHO PQT requirements and prepare legacy dossiers or new product dossiers in this format.
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Phase 1
Commencing 2024
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Companies may voluntarily submit applications for new products in eCTD format.
Companies may voluntarily submit Post-PQ Change applications to convert existing prequalified Product dossiers to eCTD.
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Phase 2 (+ 1 year)
Commencing 2025
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Companies must submit applications for new products in eCTD format.
Companies should submit Post-PQ Change applications to convert existing prequalified Product dossiers to eCTD.
In addition, the FPP Requalification procedure will now be used as an opportunity to request a conversion of prequalified Product dossiers to eCTD.
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Phase 3 (+ 2 years) Commencing 2026
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Both new and legacy product dossiers must be in eCTD format for APIMFs, API-PQs, and FVPs.
Companies must submit applications for new FPP products in eCTD format. The FPP Requalification procedure will continue to be used to convert any remaining legacy Product dossiers to eCTD.
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(Source: eCTD Portal, World Health Organization. Retrieved 21 November 2023, from https://extranet.who.int/prequal/ectd-portal)
Streamlining eCTD Submissions for Success
Navigating the intricate process of eCTD submissions is simplified with EXTEDO's eCTDmanager. This powerful tool facilitates the creation, management, and validation of applications. Its user-friendly interface allows for seamless electronic submissions without needing prior XML technology knowledge. Plus, the built-in technical validation ensures compliance with the latest criteria set by authorities, including the WHO. This validation functionality can also be acquired as a stand-alone solution, EURSvalidator.
EXTEDOpulse – the RIM Platform for Effortless Compliance
Both eCTDmanager and EURSvalidator are part of our comprehensive end-to-end RIM platform EXTEDOpulse. From drug development to market launch and pharmacovigilance surveillance, EXTEDOpulse is the right unified RIM solution from the start for every step of the way, introducing next-level automation to optimize your team’s productivity.
As the trusted bridge between agency and industry, we understand the complexities of regulatory processes and know-how organizations can achieve Effortless Compliance. Contact us any time if you would like to improve the efficiency and security of your company’s regulatory processes. We are looking forward to hearing from you.
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If you are looking for further information on how to handle eCTD for WHO-PQT, you can find additional documents here:
eCTD - 2023 10 18 PQT Validation Criteria v 1.0
eCTD - FAQ WHO PQT
eCTD - WHO eCTD guidance for Industry
eCTD - WHO PQT eCTD checksums
eCTD - WHO PQT Technical Files
eCTD - WHO PQT Valid Values XML
eCTD - WHOPQT eCTD M1 Specification (Files-Elements-Folders)
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