Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.
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Collaborative Registration Procedure for medical products

The WHO Collaborative Registration Procedure (CRP) is a reliance and collaboration mechanism to facilitate and accelerate the assessment and registration of medical products in participating countries. Through CRP, National Regulatory Authorities (NRAs) can access product assessment reports from stringent regulatory authorities (SRAs) or WHO Prequalification, allowing for a faster, verification-based or abridged review process to make their own decision. The aim is for NRAs to be able to issue a regulatory decision within 90 working days which facilitates quick access to medical products for the public. Participation in the CRP is voluntary, and the ultimate decision lies with the NRA ensuring sovereignty of the country is maintained.

Enhanced collaboration and information exchange between NRAs and with WHO improves regulatory efficiency by accelerating timelines for product approval, minimizing duplication and regulatory resources, promoting collaboration and reallocating national resources to critical areas such as post-market and market surveillance. The Collaborative Procedure also benefits manufacturers of WHO-prequalified IVDs through faster and better harmonized regulatory approvals in participating countries and contributes to alleviating the burden of additional national inspections on manufacturers and performance evaluations.

Implementation of CRP requires signing of a participation agreement by the NRA confirming their commitment to adhere with the requirements of the Procedure i.e., resources (focal point) and timelines. Another important stage is indication of interest by the manufacturer or their representative (also known as the applicant) to register the prequalified product. This stage requires also signing of two forms by the applicant. During the assessment stage, NRAs then receive training and support for adopting reliance and facilitated regulatory pathways (FRPs) in their processes and systems. Once a country is officially listed as a CRP participant, interested applicants can submit applications for market authorization of product(s) of interest. Applicants are expected to comply to both National and CRP requirements.

WHO collaborates closely with NRAs to create a roadmap for implementation of CRP and support its implementation. This includes implementing CRP in their NRA processes, defining reference authorities, developing/adapting guidelines and standard operating procedures (SOPs), and training NRA assessors. WHO also helps NRAs to pilot the first 1–3 products submitted using the procedure, providing the necessary support and guidance to facilitate CRP implementation. To ensure effective implementation, continuous support and awareness are maintained by WHO through regular CRP trainings to NRAs and companies, support to each CRP product submission product assessment trainings/courses, workshops, and annual meetings on the Collaborative Registration Procedure.

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