WHO Prequalification

The WHO Prequalification Unit (PQT) accepts eCTD-format applications through the ePQS portal, based on the ICH eCTD v3.2.2 structure with the WHO regional Module 1 (M1 Specification: Files-Elements-Folders, V1.01) and WHO-PQT envelope metadata. The transition timeline is currently at Phase 0: applications for new products may be submitted voluntarily in eCTD, and existing prequalified dossiers can be converted voluntarily via a Post-PQ Change (type Conversion). From Phase 2, applications for new products must be in eCTD, and Post-PQ Change conversions are expected (the FPP Requalification procedure will be used to request conversion); Phase 3 extends the requirement to all new and legacy dossiers (APIMFs, API-PQs and FVPs), with eCTD mandatory for new FPP applications. No phase dates have been announced; WHO will provide further updates as timelines become clarified.

Conversion rules in brief: applications under assessment in non-eCTD format stay in that format and convert only after assessment concludes; once a product dossier is converted, all future documents must be in eCTD; and eCTD applications cannot be submitted for a product whose dossier is still non-eCTD.