eCTD Portal

The WHO Prequalification Unit (PQT) is introducing an electronic Common Technical Document (eCTD) submission facility through the ePQS Portal for the prequalification of medicines and vaccines.

The eCTD is an internationally harmonized electronic format for submitting regulatory information and applications to regulatory authorities. It is based on the Common Technical Document (CTD) developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Further information is available on the ICH website.

The introduction of eCTD is intended to simplify document lifecycle management for both applicants and PQT, while enhancing the efficiency, consistency, and transparency of the assessment process.

Applications in eCTD format must be submitted through the ePQS Portal.

To support applicants in preparing compliant eCTD dossiers, PQT provides a range of guidance documents and technical resources, accessible through the links below. Information on the practical steps for submission is available on the ePQS Portal webpage.

The Transition Timeline to eCTD

The transition to mandatory eCTD submissions will be implemented in phases. PQT is currently in Phase 1. Phase 2 will commence on 30 September 2027.

Dossier Conversion Guidance

Applicants should note the following principles regarding dossier conversion:

• Applications currently under assessment in a non-eCTD format should remain in that format until the assessment has been completed. Conversion should occur thereafter in accordance with the transition timeline above.
• Change applications in eCTD format cannot be submitted for products that are maintained in a non-eCTD format. The product dossier must first be converted to eCTD.
• Once a product dossier has been converted to eCTD format, all subsequent submissions for that product must be provided in eCTD format.
• Conversion of a legacy product dossier to eCTD can be initiated by submitting a Post-PQ change application under the subtype eCTD Baseline.

Validation of eCTD Submissions

Before submitting an eCTD application, WHO strongly recommends the use of an eCTD validation tool to verify compliance with applicable technical and regulatory requirements.

Applicants should ensure that the validation software used is current and regularly updated. Detailed validation reports can help identify and resolve issues before submission, thereby facilitating successful acceptance and review of the dossier.

Links

Webinars

• Implementing M1 for eCTD submissions submitted to the WHO Prequalification Unit (PQT) (recorded 21 November 2023)

Documents