Speeding up access to quality medicines in Africa
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http://www.who.int/features/2013/accelerated_registration/en/
News
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 Ne
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 Enter
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 situati
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 product d
Notice of concern (NOC) withdrawn for Bombay Bioresearch Center (BBRC), India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
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Notice of concern (NOC) withdrawn for Sandoz SA (Pty) Ltd, Kempton Park, South Africa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
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
Ranbaxy products relisted and new Aurobindo products included in WHO's list of prequalified medicines
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see also: WHO Media Centre: http://www.who.int/entity/mediacentre/news/notes/2005/n
Two Cipla AIDS medicines back on WHO's list of prequalified medicines: generic manufacturers continue to upgrade their practices
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WHO News Release WHO/87, WHO Geneva.
Hetero Drugs Ltd. withdraws antiretrovirals from WHO prequalification list for further review
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WHO, Geneva.
Ranbaxy withdraws all its antiretroviral medicines from WHO's list of prequalified products
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WHO Geneva.
Removal of antiretroviral products from the WHO list of prequalified medicines
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WHO Geneva. Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS
Four news AIDS medicines added to WHO's list of prequalified medicines
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New edition of WHO prequalification list to include four new anti-AIDS medicines; assessment reports to be made public in coming days
UN agency drops 2 drugs for AIDS care worldwide
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From The New York Times, 16 June 2004
By Lawrence K. Alyman & Donald G. McNeil Jr.
Generic AIDS drugs on UN list
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From The New York Times, Thursday, March 21, 2002
Inclusion of products is setback for pharmaceutical giants.
New list of safe AIDS drugs, despite industry lobby
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From The New York Times Thursday, March 20, 2002
By Donald G. McNeil Jr.
World Health Organization prepares list of 'quality' AIDS medication
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From The Wall Street Journal, 20 March 2002
By Rachel Zimmerman