Accelerating Access to IVDs through Collaborative Registration Procedure
This content discusses the Collaborative Registration Procedure (CRP) for In Vitro Diagnostics (IVDs), aiming to expedite national registration of quality-assured IVDs. Through information sharing between WHO Prequalification (PQ) and National Regulatory Authorities (NRAs), the CRP facilitates a shorter pathway to registration by optimizing resources and ensuring confidentiality. Updates on progress, agreements signed, and registered IVDs using CRP are highlighted, emphasizing the goal of accelerating access to essential diagnostics. Guidelines and reports shared for review and evaluation, along with milestones achieved during joint meetings, are outlined.
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Presentation Transcript
Collaborative Registration Procedure Updates Jennifer Kealy 1 Virtual Joint Meeting 08 10 March 2022
Using CRP to accelerate access to IVDs NRA and Manufacturer of IVD sign agreements to permit confidential data sharing RELIANCE MECHANISM Avoid duplication of effort NRA experts can review WHO findings from PQ Assessment Accelerate decision on registration GOALS Shorter pathway to national registration for quality assured IVDs Optimization of resources for participating countries Guidelines published on WHO Website https://www.who.int/publications/m/item/collaborative- procedure-between-the-who-and-nra-s-in-the-assessment-and-accelerated-national-registration-of- who-prequalified-ivd-s-annex4 2 Virtual Joint Meeting 08 10 March 2022
Collaborative Registration Procedure for IVDs Aims to accelerate country registration of prequalified IVDs through information sharing between WHO PQ and National Regulatory Authorities PQ Process PRINCIPLES Voluntary for Mx of prequalified IVDs Product sameness must be guaranteed Confidentiality of data shared Target timeline for NRA decision CRP WHO PQ Reports WHO PQ REPORTS SHARED Product dossier review Site Inspection Performance Evaluation Target: 90 days 3 Virtual Joint Meeting 08 10 March 2022
CRP for IVD: Progress update 2021 The guideline was officially published Annex 4 of WHO Technical Report Series, No. 1030, 2021 https://www.who.int/publications/i/item/9789240024373. NRAs from 13 countries have signed CRP agreements Three IVDs were registered using the CRP Malaria RDT, HIV RDT and HIV/Syphilis RDT 9thAnnual CRP meeting for National Regulatory Authorities (NRAs) held Dec 2021 CRP introduction sessions held with 4 NRAs CRP Dossier review reports prepared for 14 Prequalified IVDs Rwanda Nigeria Mauritania Uganda South Africa Ethiopia Tanzania Zanzibar Zambia Mozambique Ivory Coast Cameroon Ghana 4 Virtual Joint Meeting 08 10 March 2022
