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.

• Guidance on Norms and Standards

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.

• Full text - Challenges and responses
• See also: Globalization and Trade
• Technical Cooperation

For more information, please contact the qsm@who.int

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