Improving access to new diagnostics through harmonised regulation: priorities for action.

A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient or overzealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, as well as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable.