Generic Medicines — WHO Prequalification Readiness
Country
WHO / International Procurement
Official organization
World Health Organization (WHO)
Category
prequalification
Product / sector
Pharmaceuticals
Publication / issue date
Not published by source
Document version
Not specified
Official source
Full Assessment — Multisource (Generic) FPPs
OFFICIAL SOURCE FACTS / REQUIREMENT FRAMEWORK
What you need to know
WHO identifies API and FPP quality, bioequivalence and manufacturing-site GMP requirements for full assessment of multisource FPPs. Related CRO inspection may be needed.
WHO guidance uses the modular Common Technical Document structure. Exact dossier and evidence requirements remain product-specific.
This summary is not a complete regulatory checklist. Applicability, conditions and exclusions remain governed by the original official document.
Who is affected
Manufacturers
Suppliers / Wholesale Distributors
Exporters
Regulatory Teams
Quality Teams
Business Development
Procurement Teams
PHARMA GATE INTERPRETATION — NOT AN OFFICIAL REQUIREMENT
Pharma Gate Intelligence
Use this pathway to organize review, not to predict an assessment outcome. Completing the visual sequence does not guarantee prequalification.
Business impact
Product-specific evidence and supplier requirements can affect planning and participation. Neither national authorization nor an award is guaranteed.
RECOMMENDED ACTION — NOT A REGULATORY DETERMINATION
What to check
Current EOI and product applicability
API / FPP quality evidence and applicable bioequivalence approach
Site readiness and current CTD guidance
Recommended next step
Review the applicable current WHO documents and the specific product or procurement notice with qualified professional support.
Independent professional support pathways. Pharma Gate does not assess eligibility, certify suppliers or submit applications to WHO.
VERIFIED SOURCE GOVERNANCE
Official facts are attributed to issuing authorities. Pharma Gate analysis and recommended actions are clearly separated.
How we verify intelligence
Official facts are attributed to the issuing organization. Pharma Gate interpretation and recommended actions are separate editorial layers, not legal requirements or regulatory approval. Sources are prioritized: national regulators, WHO and recognized intergovernmental bodies, official procurement organizations, then other official governmental or institutional sources.
Publication records retain source title, version, issue date, verification date, country, sector and status. Draft / Public Consultation is distinct from Current. Superseded and Archived records do not represent current requirements. A verification date records the review performed; it is not an assurance of continuous monitoring. Always check the latest official source before acting.
