Pre-submission meetings
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Pre-submission meetings provide an opportunity for advice and guidance prior to submission of a medicines dossier, as well as an opportunity for the applicant to meet the PQT medicines (PQTm) asses
Minimum stability data required at the time of filing a generic product application
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The previous exception to allow 3 months stability data (at time of submission) for RH and 2nd line TB products was made, as an interim measure, to encourage the submission of poorly-represented pr
First kanamycin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First Etravirine Active Pharmaceutical Ingredient (API) prequalified
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Etravirine (WHOAPI-280) manufactured by Mylan Laboratories Ltd has
First generic magnesium injection prequalified
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WHO Prequalification Team: medicines (PQTm) added the below new products to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Pyrimethamine (WHOAPI-278) and sulfadoxine (WHOAPI-279) manufactured by Gu
15th Invitation to manufacturers and suppliers of medicinal products for HIV infections and related diseases to submit and Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
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The following products were added:
- Lamivudine/Abacavir/Dolutegravir, tablet 30mg/60mg/5mg dispersible
WHO to begin pilot prequalification of biosimilars for cancer treatment
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This year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and midd
First sofosbuvir active pharmaceutical ingredient (API) prequalified
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Sofosbuvir (WHOAPI-290) manufactured by