New WHO Public Assessment Reports (WHOPARs) published
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News
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Notice of concern (NOC) withdrawn for Bombay Bioresearch Center (BBRC), India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
Revised WHO good practices for pharmaceutical quality control laboratories
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The WHO Prequalification of Medicines Programme has posted on its website revised WHO Good Practices for Pharmaceutical Quality Control Laboratories, Annex 1 (WHO T
Notice of concern (NOC) withdrawn for Sandoz SA (Pty) Ltd, Kempton Park, South Africa
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Following re-inspection of Sandoz SA (pty) Ltd, Kempton Park site in South Africa, the WHO Prequalification of Medicines Programme has
Requalification to start
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In accordance with the provisions set out in sec
Notice of concern (NOC) withdrawn for Matrix Laboratories Ltd.
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Following corrective actions taken by Matrix Laboratories Ltd and the clarifications provided being
WHO Medicines Prequalification Programme statement regarding Ranbaxy, Paonta Sahib, India manufacturing site
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WHO is aware of the recent actions taken by the USA Food and Drug Administration (FDA) against the Ranbaxy, Paonta Sahib, India manufacturing site.
Creation of new WHO Public Inspection Report (WHOPIR) section: Archived WHOPIRs
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As changes in manufacturing sites and activities on sites may change, it is suggested that all users of the list of prequalified products and WHOPIRs verify with the manufacturers