Essential medicines and health products

Norms and Standards: 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

Challenges and responses

The increasing globalization of commerce and trade, and the merging of pharmaceutical companies, are internationalizing the pharmaceutical production. International norms and standards for medicines are thus more important than ever before. WHO continues to develop such international norms and standards, and assists countries implementing them. Because medicines are relevant to priority health needs and public health; high standards of quality, safety, and efficacy of medicines must be ensured and reliable systems of medicines regulation and legislation need to be within the reach of every country.

Enquiries and contact

For more information, please contact the

Dr L. Rägo
Department of Medicines Policy and Standards (HTP/PSM)
World Health Organization
1211 Geneva 27
Fax: +41 22 791 47 30