Regulatory approval for diagnostics is costly, lengthy and lacks transparency in many countries. It is seen as a major barrier to innovation and access. We seek to survey the regulatory landscape and develop a clearly defined set of standards and a critical path for streamlining the approval of a new generation of diagnostics that are affordable, easy to use and work on plug-and-play type devices. We will work closely with product standards setters, departments of health, the diagnostic industry, regulatory authorities and regional harmonization working parties to develop a transparent model framework for rapid and efficient approval of this novel class of diagnostics, and for the harmonization of regulatory processes in the developing world to ensure that patient needs are met in all resource settings. The second phase of the project is to develop and pilot a streamlined and harmonized regulatory process for the approval of a point-of-care (POC) IVD. We will combine scientific, technological, social and business innovations to seed regulatory reform. We will work with regional harmonization working parties as implementing partners to focus on four potential areas of harmonization: 1) a Standard Technical Document (STED) for registration of POC IVDs; 2) convergence of standards for quality audits of POC IVD manufacturing sites: 3) a mechanism to reduce duplication in clinical trials for validating the performance of a POC IVD; 4) a system for post-marketing surveillance. The project will deliver a set of harmonized regulatory standards and project outcomes will be disseminated for adoption by regions and countries.
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