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WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
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PQT Home
Product Streams
Immunization Devices
Menu Column 1
About Immunization Devices Prequalification
What We Do
Documents A-Z
WHO Catalogue of Prequalified Immunization Devices
Menu Column 2
Procuring Prequalified Products
Standards Overview
Prequalification Procedures & Fees
Evaluation process
Retroactivity and grandfathering
Product Testing Support for Manufacturers
Laboratory Accreditation for Product Testing
Menu Column 3
Post-prequalification Procedures & Fees
Post-market Monitoring
Enhancing post-market monitoring
Guidance Documents
Prequalification guidance for manufacturers
Performance specifications
Verification protocols
Target product profiles
Standard operating procedures
Supporting information for users
Market Information
In Vitro Diagnostics
Menu Column 1
About In Vitro Diagnostic & Male Circumcision Device Prequalification
What We Do
Documents A-Z
Prequalified In Vitro Diagnostics
Prequalified Male Circumcision Devices
In Vitro Diagnostics Under Assessment
Menu Column 2
IVDs Eligible for WHO Prequalification
MCDs Eligible for Prequalification
MCDs Under Assessment
Prequalification Procedures & Fees: IVDs
Prequalification Procedures & Fees: MCDs
Post-prequalification Procedures & Fees: Prequalified IVDs
Annual reporting
Changes to prequalified IVDs
Post-market surveillance
Post-prequalification Procedures: Prequalified MCDs
Menu Column 3
Prequalification Reports
WHO Public Reports
WHO Public Inspection Reports
Collaborative Procedure for Accelerated Registration
Guidance Documents
Prequalification guidance
Technical Specifications Series
Technical Guidance Series
Sample product dossiers
Support to Manufacturers
Technical advice
Pre-submission meetings
Specialized technical assistance
Emergency Use Listing Procedure
Expert Review Panel for Diagnostics
Market Information
Medicines
Menu Column 1
About Medicines Prequalification
What We Do
Documents A-Z
Prequalification Pipeline
FPPs under assessment
Prequalified Lists
Finished pharmaceutical products
Active pharmaceutical ingredients
Medicines quality control laboratories
FPPs and APIs Eligible for Prequalification ("EOIs")
Menu Column 2
Prequalification Procedures & Fees: FPPs, APIs & QCLs
Medicines / FPPs
Active pharmaceutical ingredients
Medicines quality control laboratories
Post-prequalification Procedures & Fees: APIs, FPPs, QCLs
Amendments to APIMFs
Variations to FPPs
Requalification of FPPs
Quality monitoring
Monitoring QCL performance
Prequalification Reports
WHO Public Assessment Reports
WHO Public Inspection Reports
Collaborative Procedures for Accelerated Registration
Accelerated registration of prequalified FPPs
Accelerated registration of FPPs approved by SRAs
Menu Column 3
Guidance Documents
WHO Technical Report Series
WHO medicines prequalification guidance
International Pharmacopoeia
Pilot Prequalification of Biotherapeutic Products
Support to Manufacturers, CROs and QCLs
Technical advice
Pre-submission meetings
Specialized technical assistance
Capacity building for QCLs
Risk Assessment
Market Information
Vaccines
Menu Column 1
About Vaccines Prequalification
What We Do
Documents A-Z
List of Prequalified Vaccines
Prequalified vaccines
Menu Column 2
Vaccines Eligible for WHO Prequalification
Prequalification Procedures & Fees
Assessment
Fees for prequalification
Post-prequalification Procedures
Variation classification
Prequalified vaccine annual report (PQVAR)
Reassessment
Targeted testing
Complaints handling by WHO
Menu Column 3
Guidance Documents
WHO Technical Report Series
WHO position papers
SAGE reports
Biological reference preparations
Vaccine information by disease category
Prequalification Reports
WHO Public Assessment Reports
WHO Public Inspection Reports
Emergency Use Listing Procedure
Market Information
Risk Assessment - Snake Antivenom
Snake antivenom assessment procedure
Call for Applications
List of Product Assessment Outcomes
TAG-SAIL
Guidelines
Vector Control Products
Menu Column 1
About Vector Control Products Prequalification
What We Do
Documents A-Z
Menu Column 2
List of Prequalified Vector Control Products
Prequalification Pipeline
Prequalification Procedures & Fees
Determination of pathway
Pre-submission
Dossier preparation
Submitting applications
Screening & assessment
Post-prequalification Procedures & Fees
Menu Column 3
Prequalification Reports
WHO Public Inspection Reports
ITN Product Review Report
WHO Specifications for Pesticides
Guidance Documents
Inspection Services
Menu Column 1
About Inspection Services
What We Do
Menu Column 2
Documents A-Z
Inspection Services Procedures
WHO Public Inspection Reports (WHOPIRs)
Menu Column 3
Notice of Concern
International Collaboration
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WHO Public Reports for In Vitro Diagnostics
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Malaria rapid diagnostics tests
Public Report for AdvDx Malaria Pf Rapid Malaria Ag Detection Test, (PQDx 0345-101-00)
Public Report for Bioline Malaria Ag P.f (HRP2/pLDH) (PQDx 0209-012-00)
Public Report for Bioline Malaria Ag P.f (PQDx 0031-012-01)
Public Report for Bioline Malaria Ag P.f/P.f/P.v (PQDx 0297-012-00)
Public Report for Bioline Malaria Ag P.f/P.v (PQDx 0125-012-00)
Public Report for Bioline Malaria Ag P.f/Pan (PQDx 0030-012-01)
Public Report for CareStart™ Malaria HRP2 (Pf), (PQDx 0137-049-00)
Public Report for CareStart™ Malaria HRP2/pLDH (Pf), (PQDx 0188-049-00)
Public Report for CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO, (PQDx 0136-049-00)
Public Report for CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO, (PQDx 0138-049-00)
Public Report for CareStart™ Malaria pLDH (PAN), (PQDx 0234-049-00)
Public Report for FalciVax-Rapid test for Malaria Pv/Pf (PQDx 0290-025-00)
Public Report for First Response® Malaria Ag. pLDH/HRP2 Combo Card Test, (PQDx 0285-010-00)
Public Report for First Response® Malaria Antigen P. falciparum (HRP2) Card Test, (PQDx 0283-010-00)
Public Report for First Response®Malaria Ag. P.f. / P.v. Card Test, (PQDx 0329-010-00)
Public Report for NxTek Eliminate Malaria Pf (PQDx 0349-012-00)
Public Report for One Step Test for Malaria Pf /Pv Ag MERISCREEN Malaria Pf/Pv Ag, (PQDx 0294-074-00)
Public report for One Step test for Malaria Pf/Pan Ag MERISCREEN Malaria Pf/Pan Ag (PQDx 0330-074-00)
Public Report for Paracheck Pf-Rapid Test for P.Falciparum Malaria Device (Ver. 3) (PQDx 0321-024-00)
Public report for ParaHIT f Ver. 1.0 Rapid Test for P. falciparum Malaria Device, (PQDx 0062-023-00)
Public Report for Parascreen - Rapid test for Malaria Pan/Pf (PQDx 0291-025-00)
Public Report for STANDARD Q Malaria P.f Ag Test, (PQDx 0346-117-00)
Public Report for STANDARD Q Malaria P.f/P.v Ag Test, (PQDx 0348-117-00)
Public Report for STANDARD Q Malaria P.f/Pan Ag Test, (PQDx 0347-117-00)
