WHO TRS (Technical Report Series) 908, 2003 Annex 2

The International Pharmacopoeia : revised concepts and future perspectives

General Context and Overview:

WHO Constitution and World Health Assembly:

The quality of pharmaceuticals has been a concern of WHO since its inception. The setting of global standards is requested in Article 2 of the WHO constitution which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. The World Health Assembly has adopted many resolutions requesting the Organization to develop international standards, recommendations and instruments to assure the quality of medicines, whether produced and traded nationally or internationally. In addition, many national governments support the activities of WHO Collaborating Centres financially.

Expert Committee and activities related to The International Pharmacopoeia:

In response to the World Health Assembly resolutions, the WHO Expert Committee on Specifications for Pharmaceutical Preparations, which was originally established to prepare The International Pharmacopoeia, has made numerous recommendations relevant to quality assurance and control.

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WHO TRS (Technical Report Series) 908, 2003 Annex 2: