The development of norms, standards and guidelines to promote quality assurance for pharmaceuticals is an integral part of WHO’s Constitution and has been endorsed and supported through numerous World Health Assembly resolutions.

Access to quality pharmaceuticals is important and can be a major public health challenge, in light of the growing cross-border activities. The World Health Assembly has therefore adopted many resolutions requesting the organization to develop international standards, recommendations and instruments in order to assure the quality of medicines, whether they are produced and traded nationally or internationally.

The norms and standards are intended for use by national regulatory authorities, pharmaceutical manufacturers and other interested parties.

Norms and standards for pharmaceuticals are developed following recommendations by:

• WHO governing bodies,
• the International Conference of Drug Regulatory Authorities,
• the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP),
• international organizations and United Nations agencies,
• other WHO programmes and activities, or in response to major public health needs,

and are thereafter adopted by the ECSPP.