WHO PQT launches eCTD submissions through the ePQS Portal

The WHO Prequalification Unit (PQT) has launched eCTD submission capability through the ePQS Portal. The eCTD is a globally harmonized format for electronic regulatory submissions that will improve dossier lifecycle management and streamline the assessment process.

PQT is implementing the transition in phases, with voluntary adoption currently underway and mandatory eCTD submission for all new applications starting on 30 September 2027. Guidance documents, technical specifications, FAQs, and training materials are available to support applicants in the transition to eCTD.