WHO recommends that before a medicinal product is introduced to a market, the responsible government ensures it meets acceptable standards for safety, efficacy and quality. This includes adherence to good manufacturing practices. Reviewing safety, efficacy and quality of data – submitted through marketing authorization applications, registrations and throughout the product life cycle (including post-approval changes) – is a critical regulatory function that safeguards public health against harmful products.

This product review process is multidisciplinary, requiring expertise in areas such as drug discovery and development, preclinical and clinical research, chemistry, pharmaceutical manufacturing, legal and regulatory frameworks, information technology, analytical methods, public health, and standard practices in medicine use settings.