New WHO Public Inspection Reports (WHOPIRs) published
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News
First rituximab similar biotherapeutic products prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Ipca’s dispersible zinc tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Zhejiang Jiangbei’s efavirenz tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Macleods’ dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Request for Proposals: Support to Director, Regulation and Prequalification (RPQ) Department and to RPQ Unit Heads
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IVD
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This is a request for proposals for consultancy services
Question & Answer - COVID-19 and WHO PQT Inspections
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On 30 January 2020, WHO Director-General, Dr Tedros Ghebr
Laboratorios Leon Pharma’s levonorgestrel/ethinylestradiol tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Emcure’s emtricitabine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO Prequalification Unit – Medicines request to manufacturers to conduct risk assessments to evaluate the potential for the presence of nitrosamine impurities
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Background
Medicine Regulatory Authorities firs
First meropenem prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Strides’ sofosbuvir 400 mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Emcure’s dolutegravir 50 mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Incepta’s medroxyprogesterone injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Harvest Pharmaceutical’s kanamycin injection prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Lupin’s emtricitabine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO publishes Emergency Use Listing procedure and roadmap to make new medical products more readily available during health emergencies
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WHO published the Emergency Use Listing (EUL) procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
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: