Annex 11: Good regulatory practices in the regulation of medical products

A fundamental role of government is to ensure the health and safety of the public, which includes providing quality health care. Essential to this is the availability of medical products that are safe, effective, and of assured quality. Given the critical nature of medical products in disease prevention, diagnosis, and treatment, the consequences of substandard products can be life-threatening. Regulatory bodies are entrusted to ensure that only legal products are available and that they meet the required safety and quality standards. The globalization of product development and supply, combined with rapid technological and social changes, has made the regulation of medical products increasingly complex. Recognizing this, the Sixty-Seventh World Health Assembly endorsed the importance of robust regulatory systems. Effective regulatory systems require a framework of laws, regulations, and guidelines, supported by competent authorities. Good Regulatory Practices (GRP) are crucial for the efficient performance of a regulatory system, ensuring public trust. This document presents principles of GRP, emphasizing legality, consistency, independence, impartiality, proportionality, flexibility, clarity, efficiency, and transparency. Implementing these principles ensures that regulations are clear, consistent, and science-based, fostering public confidence in the regulatory system.