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Information on Dossier Assessments
A manufacturer
wishing their medicinal products to be included in the
prequalified products list must submit extensive information
on the product (or products) to allow qualified
teams of assessors to comprehensively evaluate its quality, safety and
efficacy. The manufacturer must also open its manufacturing
and clinical sites to an inspection team to assess
compliance with WHO Good Manufacturing Practices (GMP) and
WHO Good Clinical Practices (GCP) and Good Laboratory
Practices (GLP), respectively.
A team of assessors
evaluates all the data presented in each part of the dossier
(Quality and Efficacy/Safety). When both parts of the
dossier are judged as being in compliance with the
Prequalification Programme guidelines the dossier will be
accepted. The list of product
dossiers currently under scientific evaluation in the
Prequalification Programme: 
Notice of Suspension
When both the
product dossier and all relevant manufacturing and clinical
sites have been found acceptable the product can be
prequalified and listed on the Prequalification Programme
website, together with the applicant's name and the
corresponding manufacturing site of the finished product. The purpose of the
WHO Public Assessment Report (WHOPAR) is to provide all
interested parties with transparent access to information on
the procedure followed for the assessment of a
pharmaceutical product, which has been prequalified. In
addition, the WHOPAR aims to provide relevant information on
the product’s quality, safety and efficacy. |