WHO Launches the PQP Collaborative Registration Procedure. WHO Prequalification of Medicines Programme. (WHO Drug Information Vol. 27, No. 4, 2013)
(2013; 7 pages)

Abstract

The Collaborative Registration Procedure (CRP) for WHO-prequalified products accelerates registration through improved information sharing between the WHO Prequalification of Medicines Programme (PQP) and national medicines regulatory authorities (MRAs).

The CRP aims to leverage the work of PQP during registration of WHO-prequalified medicines. It enables MRAs to utilize outcomes of PQP evaluations and inspections - thereby eliminating duplication of work, speeding up delivery of quality-assured products and making these more widely available. Since 2012, when the pilot phase began, fifteen MRAs in fourteen countries have decided to participate in the CRP and the present article describes experiences and lessons learned during the launch of this activity.

 
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