Emergency Use Listing Procedure - Deadline extended to 15 December 2018
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DEADLINE EXTENDED TO 15 DECEMBER 2018
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
UPDATE: WHO Position paper on Qinhuangdao Zizhu Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) manufacturing site following the issue of the USFDA import alert
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On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017.
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