Essential medicines and health products

Quality, safety and efficacy of medicines

WHO's mandate is to “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products” (Article 2, WHO Constitution). WHO Member States rely on WHO for expertise and guidance in regulation, safety and quality assurance of medicines through development and promotion of international norms, standards, guidelines and nomenclature.


WHO provides relevant expertise and technical assistance through various activities in the areas of Quality Assurance, Regulation and Legislation, Safety and Efficacy.

Activities comprise guideline development, workshops and training courses, coordination and promotion of pharmacovigilance for global medicine safety, regulatory and other information exchange, and review of narcotic and psychotropic substances.

Areas of work

Quality assurance of medicines

Regulation and legislation

Safety and efficacy of medicines

Alerts, pharmacovigilance, information exchange, utilization of medicines