The International Pharmacopoeia (Ph.Int.) - general information

The International Pharmacopoeia (Ph. Int.) comprises a collection of quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms together with supporting general methods of analysis, that is intended to serve as source material for reference or adaptation by any WHO Member State wishing to establish pharmaceutical requirements. The pharmacopoeia, or any part of it, shall have legal status, whenever a national or regional authority expressly introduces it into appropriate legislation. [ Published in accordance with World Health Assembly resolution WHA3.10, WHO Handbook of Resolutions and Decisions, Vol. 1, 1977, p. 127.]

The activities related to The International Pharmacopoeia are an essential element in the overall quality control and assurance of pharmaceuticals contributing to the safety and efficacy of medicines. The selection of monographs for inclusion in The International Pharmacopoeia recognizes the needs of specific disease programmes and the essential medicines nominated under these programmes; it is based primarily on those substances included in the current WHO Model List of Essential Medicines.

:: Annex 2 The International Pharmacopoeia: revised concepts and future perspectives

:: WHO Model List of Essential Medicines

The work on The International Pharmacopoeia is carried out in collaboration with members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations and with other specialists. The process involves consultation of and input from WHO Member States and drug regulatory authorities, WHO Collaborating Centres and national drug quality control laboratories in all six WHO regions, standard-setting organizations and parties, including regional and national pharmacopoeias and with manufacturers around the world. Clearly defined steps are followed in the development of new monographs. [see under The International Pharmacopoeia - monograph development]

:: WHO Expert Committee on Specifications for Pharmaceutical Preparations

The International Chemical Reference Substances (ICRS) required to support the monograph specifications in The International Pharmacopoeia are established on the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations by the WHO Collaborating Centre for Chemical Reference Substances. Information about the ICRS is available from the centre

:: The WHO Collaborating Centre for Chemical Reference Substances

:: For more information please click here: [pdf 35kb]