First eCTD application received at WHO PQT via the ePQS Portal

The WHO Prequalification Unit is pleased to announce the successful submission of its first eCTD formatted dossier via the recently opened ePQS Portal.

The Vaccine Prequalification application was submitted from Serum Institute of India Pvt. Ltd., who had previously supported the pilot phase of the ePQS portal.

We would like to thank all of the companies that collaborated with PQT during the pilot trial phase, and to congratulate Serum institute of India them on this achievement.

The ePQS portal is the externally facing portion of ePQS.  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 and for the submission of documents in eCTD format.

Further information on the portal can be located at this link: https://extranet.who.int/prequal/epqs/epqs-portal