The WHO Prequalification (PQT) Unit is pleased to announce the opening of the ePQS portal to external users on 19 May 2025. The ePQS portal is the final piece of a major effort, over several years, to bring together on a single data base and document management system, all of the teams within PQT. Significantly, ePQS also includes an eCTD1 document repository.
The ePQS portal is the externally facing portion of ePQS and allows applicants to view Application and Product records relevant to their organization. Via the portal, applicants are guided by application wizards to create and submit applications to PQT. This includes the uploading of related documents in a secure manner. Similarly, correspondence from PQT to the applicants is also available for secure download.
For manufacturers of Active Pharmaceutical Ingredients, Finished Pharmaceutical Products and Vaccines, the ePQS portal permits the submission of application documents in eCTD format.
From 19 May manufacturers may register for the ePQS portal. From the Portal Landing page users can download the user registration before sending these to the relevant assessment team.
Further announcements regarding training for users will be made. Please continue to check for new or updated guidance on the PQT website’s ePQS portal webpage and eCTD webpage.
Please note that the launch of ePQS for the WHO Collaborative Registration Procedure will be announced in the coming months.
For any questions please contact Dr Antony Fake, PQT/MED at fakea@who.int, cc Dr M. Stahl, PQT Unit Head a.i. (stahlm@who.int)
- eCTD or electronic Common Technical document format allows for the electronic submission of the Medicine and Vaccine information in Common Technical Document (CTD) from the applicant to regulator.
For more information see ICH Official web site : ICH