The 9th annual collaborative registration procedure (CRP) meeting for National Regulatory Authorities (NRAs) was held 13 - 17 December. On the first day of the meeting a specific session on prequalified IVDs provided an overview of the WHO-PQ process to assess quality, safety and performance of IVDs process and described the dossier review, site inspection and performance evaluation reports produced during the WHO PQ assessment. The CRP was presented as a pathway for the WHO PQ outcomes to be leveraged by NRAs to accelerate In-country approvals of prequalified IVDs. The session also incorporated a panel discussion to explore the role of other key stakeholders, such as the National Reference Laboratories (NRLs) and Ministries of Health in facilitating approval/market authorization of such products.
If you have a question regarding this page or related to this topic, please do not hesitate to contact the PQ team at diagnostics@who.int