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

Area of Science:

• Medical Diagnostics
• Regulatory Science
• Global Health

Background:

• Point-of-care diagnostic tests offer early detection and treatment for infectious diseases.
• Timely and affordable access to these tests is crucial, especially in developing countries.
• Current regulatory oversight in developing nations is inconsistent, leading to market entry of substandard products or delays.

Purpose of the Study:

• To identify strategies for improving regulatory processes for diagnostic tests in developing countries.
• To balance product safety and quality with timely access to innovative medical technologies.
• To reduce barriers to market entry and enhance the availability of essential diagnostic tools.

Main Methods:

• Analysis of current regulatory practices for diagnostic tests in developing countries.
• Identification of priority areas for international standards convergence and joint data review.
• Proposal of four key activities: common registration files, harmonized quality standards, shared evaluation protocols, and collaborative post-market surveillance networks.

Main Results:

• Weak regulation allows poor-quality tests, while inefficient regulation causes delays and increases costs.
• Four priority areas identified for regulatory harmonization: pre-market approval, manufacturing inspections, clinical performance studies, and post-market surveillance.
• Convergence of standards and joint review can reduce duplication and accelerate access.

Conclusions:

• Implementing harmonized international standards and streamlined regulatory processes can significantly improve access to safe, high-quality, and affordable diagnostic tests in developing countries.
• These measures facilitate innovation and ensure that essential medical products reach patients without undue delay.
• Collaborative regulatory approaches are key to strengthening global health security through early disease detection.