Integrated Innovation Approaches to Point-of-Care Diagnostics Regulation Harmonization

Regulatory approval for diagnostics is costly, lengthy and lacks transparency in many countries. It is seen as a major barrier to innovation and access. This project seeks 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. It 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.