Abridged prequalification assessment: prequalification of in vitro diagnostics
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World Health Organization
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13 p.
This document provides guidance on the WHO abridged prequalification assessment process for in vitro diagnostics (IVDs). Developed by the WHO Regulation and Prequalification Department, it explains the eligibility criteria, procedural requirements and assessment components applicable to IVDs that have previously undergone stringent regulatory assessment by recognized regulatory authorities. The abridged pathway is intended to reduce duplication of effort and shorten the prequalification process while ensuring that products continue to meet WHO prequalification requirements, particularly for use in resource-limited settings. The publication describes the rationale for abridged assessment and outlines each stage of the process, including pre-submission, eligibility determination, abridged product dossier review, manufacturing site inspection, performance evaluation, labelling review, prequalification decision and application cancellation. It specifies the evidence required to demonstrate prior stringent regulatory approval, identifies recognized stringent regulatory authorities and explains the circumstances under which products qualify for either abridged or full assessment. Annexes provide detailed requirements for the abridged product dossier and the information package supporting manufacturing site inspections.
This document provides guidance on the WHO abridged prequalification assessment process for in vitro diagnostics (IVDs). Developed by the WHO Regulation and Prequalification Department, it explains the eligibility criteria, procedural requirements and assessment components applicable to IVDs that have previously undergone stringent regulatory assessment by recognized regulatory authorities. The abridged pathway is intended to reduce duplication of effort and shorten the prequalification process while ensuring that products continue to meet WHO prequalification requirements, particularly for use in resource-limited settings. The publication describes the rationale for abridged assessment and outlines each stage of the process, including pre-submission, eligibility determination, abridged product dossier review, manufacturing site inspection, performance evaluation, labelling review, prequalification decision and application cancellation. It specifies the evidence required to demonstrate prior stringent regulatory approval, identifies recognized stringent regulatory authorities and explains the circumstances under which products qualify for either abridged or full assessment. Annexes provide detailed requirements for the abridged product dossier and the information package supporting manufacturing site inspections.