EMA Art 58 positive opinion for Pyramax granules for oral suspension - now included in PQ List
Product included:
Product included:
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list
New addition:
Information for manufacturers who experience delays in national registrations of prequalified medicines
http://www.who.int/features/2013/accelerated_registration/en/
On 16 January 2013, an article entitled �Study questions generic HIV drug use� appeared on BBC News Health.
In a number of publications since July 2012 Roger Bate of the American Public Enterpris
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.