Essential medicines and health products

The International Pharmacopoeia (Ph.Int.)

The International Pharmacopoeia (Ph. Int.) is published by WHO with the aim to achieve a wide global harmonization of quality specifications for selected pharmaceutical products, excipients and dosage forms. The activities related to Ph.Int. are an essential element in overall quality control and assurance of pharmaceuticals contributing to the safety and efficacy of medicines. The first volume of Ph.Int. was published in 1951.

This section provides an overview of Ph.Int. free online search, work plan and the ways to become involved in the work of Ph.Int. for quality control laboratories, the pharmaceutical industry, regulatory authorities and any other interested parties.

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]

International Chemical Reference Substances (ICRS)

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

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