- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > prequalification of medicines
- Mots-clés > procedure for prequalification of pharmaceutical products
- Mots-clés > registration - WHO‑prequalified pharmaceutical products
- Mots-clés > registration of pharmaceuticals
- Mots-clés > WHO/PQP and NMRAs - collaborative procedure
(2013; 7 pages)
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.