New WHO Public Assessment Report (WHOPAR) published
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News
ACME Formulation's misoprostol prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new product to its prequalified list
Removal of Anuh Pharma APIs from WHO List of Prequalified APIs
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The WHO has received advice from the French Medicines Agency (ANSM) that they have issued a statement of non-compliance with GMP as a result of the recent inspection at Anuh Pharma's Boisar facility.
Notice of Suspension (NOS) - Corrigenda
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The Notice of Suspension letter for Svizera Labs was published due to an administrative error and was therefore removed from the website. WHO Prequalification Team apologizes for any incovenienc
Quality Control Laboratory (QCL) newly prequalified
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Laboratory added to the List of Prequalified Quality Control Laboratories (QCLs):
EMA Art 58 positive opinion for Pyramax granules for oral suspension - now included in PQ List
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Product included:
3 products newly prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list
Quality Control Laboratory (QCL) newly prequalified
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New addition:
- State Scientific Research Laboratory (SSRL) on Quality Control of Medicines, Kiev - UKRAINE
Information for manufacturers who experience delays in national registration of prequalified medicines
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Information for manufacturers who experience delays in national registrations of prequalified medicines
Acceptance of non-plant-derived-artemisinin offers potential to increase access to malaria treatment
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Speeding up access to quality medicines in Africa
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http://www.who.int/features/2013/accelerated_registration/en/
Generic antiretroviral therapy is safe and effective
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On 16 January 2013, an article entitled �Study questions generic HIV drug use� appeared on BBC News Health.
WHO medicines prequalification response to claims of sub-standard antimalarials
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In a number of publications since July 2012 Roger Bate of the American Public Enterpris
Principles for prioritizing dossiers within WHO prequalification of medicines
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This note outlines the basic principles applied by PQP for prioritization of product dossier assessments and inspections of related sites within each therapeutic area.
Important note regarding WHO public assessment reports (WHOPARs)
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The product information is an essential part of the medicinal product. The SmPC and PIL published with the WHOPAR have been quality assured by WHO experts and reflect the si
Points to consider for inspections of biowaiver data
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The WHO Prequalification of Medicines Programme (PQP) intends to include in its inspection programme, sites that have performed comparative dissolution studies submitted in prod
Notice of concern (NOC) withdrawn for Bombay Bioresearch Center (BBRC), India
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Following corrective actions taken by Bombay Bioresearch Center (BBRC) and the clarifications provided being considered acceptable, and considering the outcome of an additional inspe
Relenza Rotacap/Rotahaler removed from WHO List of Prequalified Medicinal Products
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The Swedish Medical Product Ag