BTIF revised
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The revisions to the BTIF (Bioequivalence Trial Information Form) include the following changes to facilitate study assessment:
12th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) for prequalification
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The following active pharmaceutical ingredients (APIs) were added:
- Benzathine benzylpen
11th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs)
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The 11th invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API prequalification to the WHO Prequalification Team: medicines (PQTm
New WHO Public Inspection Reports (WHOPIRs) Published
IS
New WHO Public Inspection Reports (WHOPIRs) were published today:
Survey on change requests assessment by WHO
IVD
This survey aims to gather feedback on the updated PQDx 121 guidance, the new change request submission form, and the overall submission and assessment process.
Invitation to submit applications for WHO’s prequalification assessment
IVD
WHO is pleased to announce that the Prequalification of IVDs programme scope has been expanded to the following types of products:
New IVD prequalification listing
IVD
On 18th December the Loopamp MTBC Detection Kit manufactured by Eiken Chemical Co., Ltd. was prequalified.
Rusan’s azithromycin tabl and Ipca’s albendazole tabl prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Active Pharmaceutical Ingredient (API) Prequalified
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Levonorgestrel manufactured by Jiangsu Lianhuan Pharmaceutical Co., Ltd.