This note outlines the basic principles applied by PQP for prioritization of product dossier assessments and inspections of related sites within each therapeutic area.
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
The WHO Prequalification of Medicines Programme (PQP) intends to include in its inspection programme, sites that have performed comparative dissolution studies submitted in prod
Following corrective actions taken by Bombay Bioresearch Center (BBRC) and the clarifications provided being considered acceptable, and considering the outcome of an additional inspe
The Swedish Medical Product Ag
The WHO Prequalification of Medicines Programme has posted on its website revised WHO Good Practices for Pharmaceutical Quality Control Laboratories, Annex 1 (WHO T
Following re-inspection of Sandoz SA (pty) Ltd, Kempton Park site in South Africa, the WHO Prequalification of Medicines Programme has
In accordance with the provisions set out in sec
Following corrective actions taken by Matrix Laboratories Ltd and the clarifications provided being
WHO is aware of the recent actions taken by the USA Food and Drug Administration (FDA) against the Ranbaxy, Paonta Sahib, India manufacturing site.
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
see also: WHO Media Centre: http://www.who.int/entity/mediacentre/news/notes/2005/n
WHO News Release WHO/87, WHO Geneva.
WHO, Geneva.
WHO Geneva.
WHO Geneva. Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS
New edition of WHO prequalification list to include four new anti-AIDS medicines; assessment reports to be made public in coming days
From The New York Times, 16 June 2004
By Lawrence K. Alyman & Donald G. McNeil Jr.
From The New York Times, Thursday, March 21, 2002
Inclusion of products is setback for pharmaceutical giants.
From The New York Times Thursday, March 20, 2002
By Donald G. McNeil Jr.
From The Wall Street Journal, 20 March 2002
By Rachel Zimmerman
The presentations of the 2024 Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers which took place from 2 to 6 December 2024 at UN City, Copenhagen, Denmark are now available at:
for more information click here
UPDATE - Request for Proposals (RFP) Withdrawn for Internal Reasons
WHO Prequalification is inviting you to review the draft working document on Technical Specifications Series for submission to WHO Prequalification – Medical Device Assessment Screenin
Ensuring access to quality-assured, safe and effective therapies is a core part of WHO’s mission.
The WHO Immunization Devices and Equipment Prequalification Team is seeking to enter into a contractual agreement with a successful bidder to implement the following work packages:
WHO Member States are increasingly stepping up to increase human resources and manufacturing capacities for local production.