The Medicines and Vaccine assessment teams within the Prequalification Unit (PQT) are introducing an eCTD facility as part of the opening of the ePQS Portal
eCTD (electronic Common Technical Document) is a standard format for submitting Regulatory information (such as applications) to the Health Authorities, or in this case the Prequalification Unit. It provides a harmonized electronic means to submit in the Common Technical Document (CTD) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – www.ich.org
The purpose of introducing eCTD is to reduce the burden of document lifecycle management upon applicants and PQT, as well facilitating document review by assessors.
Submission of eCTD-based applications will occur via the ePQS portal.
Various reference documents to support companies to create an acceptable eCTD dossier are provided in the links below
Information pertaining to the practical steps aspects of submission are provided on the ePQS webpage
The transition timeline to eCTD
We are currently in Phase 0. Further more specific updates will be provided as timelines become clarified
| Phase | APIMF/API-PQ Products | FPP Products | FVP Products |
| Phase 0 | eCTD submissions are not possible. Companies should take time to familiarize themselves with WHO PQT requirements and prepare legacy dossiers or new product dossiers in this format. |
| Phase 1 Commencing 2025 | 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. |
| Phase 2 (+ 1 year) Commencing 2026 | 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. |
| Phase 3 (+ 2 years) Commencing 2027 | 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. |
Dossier conversion guidance
- Applications undergoing assessment that are in non-eCTD format, should remain in non-eCTD format and be converted after the assessment has concluded.
- Applications in eCTD format cannot be submitted for a Product whose dossier is in non-eCTD format. The Product must first be converted to eCTD format.
- Once a Product Dossier has been convert to eCTD, all future application documents must be in eCTD format.
- Conversion of a legacy Product dossier can be requested by filing a Post-PQ change application of type Conversion
Validation of eCTD submissions
Prior to the eCTD submission itself, WHO recommends the use of a validator to ensure that the content fully complies with regulatory requirements and is valid. The validator used should be up to date at all times; detailed validation reports also facilitate the creation of a correct submission.
Links
Webinars
Implementing M1 for eCTD submissions submitted to the WHO Prequalification Unit (PQT) (recorded 21 November 2023)
Documents
| Name | Current Version | Legacy Version |
| eCTD - WHO eCTD guidance for Industry | V1.0 | |
| eCTD - FAQ WHO PQT | 25 October 2023 | |
| eCTD - WHOPQT eCTD M1 Specification (Files-Elements-Folders) | V1.01 | V1.0 |
| eCTD - PQT Validation Criteria | V1.1. | V1.0 |
| eCTD - ePQS Related Product and Application type matrix | 30 August 2024 | 21 March 2024 |
| eCTD - Initial application documents | 21 March 2024 | |
| eCTD - WHO PQT eCTD checksums | Here | |
| eCTD - WHO PQT Technical Files | 10 May 2023 | |
| eCTD - WHO PQT Valid Values XML | 31 August 2023 |