Prequalification Update - 01 May 2012
UNFPA invitation to manufacturers of reproductive health
The lack of prequalified reproductive
health medicines is of great concern to WHO and to partner
organizations working to improve reproductive health.
However, lack of prequalified products – irrespective of
therapeutic category – does not impede supply of products in
the short term since WHO’s Quality and Safety: Medicines
team, and the Global Fund to Fight AIDS, Tuberculosis and
Malaria (Global Fund) have created a mechanism known as the
Expert Review Panel (ERP), that provides risk-based advice
to aid decisions about procurement of products that are in
the PQP “pipeline”, but that have not yet been prequalified.
Each ERP is a discrete operation, consisting of an
invitation to manufacturers to submit a product(s) for ERP
evaluation. This is followed by technical review of the
potential quality risks for each individual product, based
on the information contained in the dossier submitted for
that product. ERP’s objective is to enable procurement
organizations to make evidence-based decisions regarding
procurement of the products submitted for evaluation.
just issued its 2nd Invitation to Manufacturers of
Reproductive Health Medicines to Submit an Expression of
Interest (EOI) for Product Evaluation by the WHO Expert
Review Panel (ERP) for Reproductive Health Medicines.
Products invited for evaluation include oral hormonal
contraceptives, injectable hormonal contraceptives,
implantable contraceptives, oxytoxics, and products for
prevention and treatment of eclampsia.
The EOI, including full details of the ERP
submission process can be found here: