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WHO Global Surveillance and Monitoring System for substandard and falsified medical products

World Health Organization WHO (2017) C_WHO
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Malaria Rapid Diagnostic Test Performance. Summary results of WHO product testing of malaria RDTs: round 1 -7 (2008 –2016)

E. Heseltine World Health Organisation (WHO) (2017) C_WHO
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: DPP® HIV 1/2 Assay, WHO reference number: PQDx 0053-006-00)

World Health Organization (2016) C_WHO
PQDx 0053-006-00 WHO PQ Public Report June/2016, version 2.0
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Malaria rapid diagnostic test performance. Results of WHO product testing of malaria RDTs round 8 (2016-2018). Summary

World Health Organization WHO; FIND; CDC (2018) C_WHO
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingu... more
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Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products Bangladesh

Directorate General of Drug Administration,, Ministry of Health and Family Welfare, People's Republic of Bangladesh (2015) C1
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WHO Prequalification of Diagnostics Programme - Public report (Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts) )

World Health Organization (2016) C_WHO
Product:BDFACSCountTM InstrumentSystemwithFACSCountTM ControlKitandBD FACSCountTM CD4ReagentKit(AbsoluteandPercentageCD4+Counts) Number: PQDx 0133-045-00 0133-045-00 WHO PQDx PR June/2016, version 2.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: AiDtm anti-HIV 1+2 ELISA, Number: PQDx 0006-005-00)

World Health Organization (2016) C_WHO
PQDx 0006-005-00 WHO PQDx PR February/2016, version 2.0
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WHO Prequalification of In Vitro Diagnostics Programme - Public Report (Product: First Response® HIV 1-2-0 Card Test, Number: PQDx 0018-010-00)

World Health Organization (2016) C_WHO
PQDx 0018-010-00 WHO PQDx PR July/2016, version 3.0
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Guideline for Application to conduct Clinical Trials in Liberia

Liberia Medicines and Health Products Regulatory Authority (LMHRA) (2014) C1
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WHO Prequalification of In Vitro Diagnostics - Public Report (Product: OraQuick HIV 1/2 Rapid Antibody Test, WHO reference number: PQDx 0159-055-00)

World Health Organization (2017) C_WHO
PQDx 0159-055-00 WHO PQ Public Report February/2017, version 5.0
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Rwanda: MOH GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN PHARMACEUTICAL PRODUCTS

Ministry of Health, Rwanda (2014) C2
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M... more
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Diagnostics, therapeutics, vaccine readiness, and other health products for COVID-19
recommended

World Health Organization WHO (2021) C_WHO
Interim Guidance, 12 July 2021; This tool was developed to assess present and surge capacities for the treatment of COVID-19 in health facilities. It allows health facilities to assess the availability and status of stockout of critical COVID-19 medicines, equipment and supplies on site and to ident... more
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Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca

Medicines and Healthcare products Regulatory Agency (MHRA) UK (2021) CC
REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
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WHO Quality assurance policy for the procurement of essential medicines and other health products

World Health Organization WHO (2021) C_WHO
The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in... more
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WHO report on the global tobacco epidemic, 2021: addressing new and emerging products

World Health Organization WHO (2021) C_WHO
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COVID-19 case management capacities: diagnostics, therapeutics, vaccine readiness, and other health products – facility assessment tool: a module from the suite of health service capacity assessments

World Health Organization WHO (2021) C_WHO
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Standard operating procedures for supply chain management of health products for neglected tropical diseases amenable to preventive chemotherapy
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World Health Organization WHO (2022) C_WHO
his first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin for trachoma and yaws; diethylca... more
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Control measures for Shiga toxin-producing Escherichia coli (‎STEC)‎ associated with meat and dairy products: meeting report

World Health Organisation (WHO) (2022) C_WHO
Although Shiga toxin-producing Escherichia coli (STEC) have been isolated from a variety of food production animals, they are most commonly associated with ruminants from which we derive meat and milk. Because of the widespread and diverse nature of ruminant-derived food production, coupled with the... more
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Diagnostics to support the eradication of yaws—Development of two target product profiles

Fongwen, N.; Handley, B.; Martin, D. et al. PLoS Neglected Tropical diseases (2022) CC
Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficu... more
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Safety and quality of water use and reuse in the production and processing of dairy products: meeting report

World Health Organisation (WHO) (2023) C_WHO
At its 48th session of Codex Committee on Food Hygiene (CCFH), the Committee noted the importance of water quality and safety in food production and processing. CCFH requested the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to provide guidan... more