First eCTD application for Active Pharmaceutical Ingredient (API) Prequalification received at WHO PQT via the ePQS Portal

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

This API Prequalification application was submitted from Zhejiang Haizhou Pharmaceutical Co., Ltd., and also represents the first eCTD submission from a Chinese manufacturer.

The ePQS portal is the externally facing portion of ePQS. Via the portal, applicants of Active Pharmaceutical Ingredients, Finished Pharmaceutical Products, In vitro diagnostic, Immunization devices, Vaccines and Vector control products 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