New WHO Public Assessment Reports (WHOPARs) published
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Past News
7th Invitation to manufacturers of medicinal products for treatment of Neglected Tropical Diseases (NTDs), to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
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Products added under:
Singl
Launch of pilot programme for international cooperation in GMP inspections of manufacturers of sterile medicinal products for human use
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International collaboration in the inspection of manufacturers of active pharmaceutical ingredients has been beneficial over the last few years (1).
Hetero’s dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First biosimilar product prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Lupin’s lamivudine/tenofovir 300mg/300mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Teva’s generic atazanavir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First co-blister of daclatasvir/sofosbuvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Cipla’s 30mg and 60mg daclatasvir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Hetero’s daclatasvir 30mg and 60mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Roche sulfamethoxazole/trimethoprim prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Celltrion’s lamivudine/tenofovir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Sun’s dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Milan’s sulfamethoxazole/trimethoprim tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Clarifications regarding carton-free supply of prequalified products packaged in bottles
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PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various
Clarifications regarding carton-free supply of prequalified products packaged in bottles
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PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various
Revised Appendix for Bioequivalence Trial Information (BTIF)
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In September 2018, an appendix was added to the Bioe
First co-pack of mifepristone oral tablet and misoprostol for vaginal administration prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Levofloxacin 750mg tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Guilin’s DHA/piperaquine 40mg/320mg and 20mg/160mg dispersible tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Guilin’s DHA/piperaquine 40mg/320mg and 80mg/640mg tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Dolutegravir/lamivudine/tenofovir tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes
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IVD
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The World Health Organization (WHO) today announced the start of a pilot programme to prequalify human insulin to increase treatment for diabetes in low- and middle-income countries.
WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries
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The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of E
Nitrosamine contamination – Recent international alerts
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The WHO Prequalification Team (PQT) is aware, and monitoring closely, announcements by major regulators regarding the presence of nitrosamine impurities in batches of sartan-related products,
WHO signs MoU with International Generic and Biosimilar Medicines Association to promote access
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Full access to medicines is hampered by a variety o
Micro Labs’ 100mg dispersible levofloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Guidance on amendments has been revised
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The guidance document on amendments to an Active Pharmaceutical Ingredient Master File (APIMF) submitted in support of a Prequalified Pharmaceutical Product (FPP) or Prequalified Active Pharmaceuti