is a pharmacopoeia issued by the World Health Organization[1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms,[2] together with supporting general methods of analysis, for global use.
Its texts can be used or adapted by any WHO member state wishing to establish legal pharmaceutical requirements.
In recent years, priority has been given to medicines of importance in low and middle income countries, which may not appear in any other pharmacopoeias, including child-friendly dosage forms.
is designed to serve all Member States, especially their national and regional regulatory authorities, organizations in the United Nations system, and regional and interregional harmonization efforts, and they underpin important public health initiatives, including the prequalification and procurement of quality medicines through major international entities, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNICEF.
are established in an independent manner via a consultative procedure and based on international experience.