The International Pharmacopoeia

The International Pharmacopoeia (Pharmacopoeia Internationalis, Ph. Int.) 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, 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.

The Ph.Int. is based primarily on medicines included in the current WHO Model List of Essential Medicines (EML) and medicines included in the current invitations to manufacturers to submit an expression of interest (EOI) to the WHO Prequalification Team – Medicines (PQT) and those of interest to other UN Organizations. 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.

The Ph.Int. 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.

The monographs published in the Ph.Int. are established in an independent manner via a consultative procedure and based on international experience. [2] Monographs on radiopharmaceuticals developed with the International Atomic Energy Agency.

Editions

SortEdition numberYearMediumNotes
1First Edition1951Print2 volumes plus supplement
2Second Edition1967Print
3Third Edition1979Print5 volumes
4Fourth Edition2006Print or CD-ROM2 volumes
5Fifth Edition2015online
6Sixth Edition2016online
7Seventh Edition2017online
8Eighth Edition2018 [1]online[1]
9Ninth Edition2019Online

See also

References

  1. 1 2 3 WHO (2018), The International Pharmacopoeia (8th ed.).
  2. ↑ Procedure for the development of monographs and other texts for The International Pharmacopoeia
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