Revised sample zinc acceptability study protocol available
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WHO Prequalification provides new advice on zinc.
News
Additional bioequivalence information now required in Module 2.7
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In order to improve the PQTm’s depth of knowledge regarding products submitted for prequalification and to better understand their performance as it potentially relates to safety and efficacy, PQTm
New appendix added to Bioequivalence Trial Information (BTIF)
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An appendix has been added to the Bioequivalence Trial Information Form (BTIF).
Updated bioequivalence and biowaiver application documents
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Updated versions of the Bioequivalence Trial Information Form (BTIF) and the Application for a biowaiver: Biopharmaceutics Classification System (BCS) fo
Shanghai Desano’s lamivudine/nevirapine/zidovudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First dispersible sulfadoxine/pyrimethamine + amodiaquine in co-blister prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First valganciclovir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
GPO’s efavirenz tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Capreomycin 500mg injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Tenofovir disoproxil fumarate (
Newly prequalified Quality Control Laboratories (QCLs)
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New addition to the List of Prequalified Quality Control Laboratories (QCLs):
Note on paediatric products in PQT Medicines
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The development of paediatric formulations for essential medicines has been recognized as a critical step for successful healthcare delivery.
First Itraconazole prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First paediatric cycloserine prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First generic rifampicin 300mg capsule
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Dolutegravir 50mg prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredient (API)
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Praziquantel (WHOAPI-309) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines under its AP
WHO kick-starts pilot prequalification of biotherapeutics for cancer treatment
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WHO today launches a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Linezolid (WHOAPI-252) and Kanamycin (acid
First liposomal amphotericin B powder for injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Second rectal artesunate capsule prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Ipca's paediatric artemether/lumefantrine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Labesfal's Mg injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hisun's kanamycin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
MSN's moxifloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
ViiV Healthcare's abacavir/lamivudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Hetero's paediatric lopinavir/ritonavir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Questions and answers on DTG use in women of childbearing age
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On 18 May 2018, WHO has issued a web statement signalling a potential risk of neural tube defects in infants born to women who were taking dolutegravir (DTG) at the time of conception.
ICHQ3D introduced for APIMF and API prequalification procedures
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The ICHQ3D guideline presents a process to assess and control elemental impurities in drug products using the principles of risk assessment.
Report on the international API inspection programme 2011 - 2016
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In April 2018, EMA published a report with an overview of the activities of the programme between 2011 and 2016.