The International Pharmacopoeia

The International Pharmacopoeia (Pharmacopoeia Internationalis, or 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,[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.[2]

Contents

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.[3] Monographs on radiopharmaceuticals developed with the International Atomic Energy Agency.

History

Early history

The first international pharmaceutical congress was held in Strasbourg in 1867, and emitted the wish that an international pharmacopoeia be compiled.[4]

The "Conference for the Unification of the Formulae of Potent Medicaments" held in Brussels in 1902 was also the 10th pharmacists' congress. It resulted in a treaty considered as the start of the international pharmacopoeial project[5] although "it took four years of textual adjustments before the Agreement could enter into force as a multilateral treaty in 19 (mostly European) countries, in December 1906"[6]

A second conference met in Brussels' Academy Palace in 1925, resulting in the revised 1925 Brussels Pharmacopoeia Agreement.[6][7]

After the Second World War, the World Health Organization took over the Brussels Agreement and its secretariat hosted by the League of Nations, and subsequently discontinued and replaced the 1925 Brussels Agreement with the International Pharmacopoeia edited since 1951.[6][8]

Editions

Sort Edition number Year Medium Notes
n/a First Brussels Agreement 1902 Table of harmonised monographs annexed to national pharmacopoeias 41 entries[4]
n/a Second Brussels Agreement 1925 Insertion of acronym "P.I." alongside monograph's titles in national pharmacopoeias[6] 76 entries[4]
1 First Edition 1951 Print 2 volumes plus supplement[2]
2 Second Edition 1967[2] Print
3 Third Edition 1979[2] Print 5 volumes
4 Fourth Edition 2006[2] Print or CD-ROM 2 volumes
5 Fifth Edition 2015[2] Online
6 Sixth Edition 2016 Online
7 Seventh Edition 2017 Online
8 Eighth Edition 2018 [1] Online[1]
9 Ninth Edition 2019 Online
10 Tenth Edition 2020 Online
11 Eleventh Edition 2022 Online

See also

References

  1. ^ a b c WHO (2018), The International Pharmacopoeia (8th ed.), archived from the original on 2011-07-09, retrieved 2015-10-16.
  2. ^ a b c d e f g Hill, Melissa Sue, ed. (2017). "The World Health Organization (WHO)". Worldmark Encyclopedia of the Nations. Farmington Hills, MI: Gale.
  3. ^ "Procedure for the development of monographs and other texts for The International Pharmacopoeia" (PDF). Archived (PDF) from the original on 2020-08-26. Retrieved 2022-02-26.
  4. ^ a b c Volckringer, Jean (1953). "Evolution et Unification des Formulaires et des Pharmacopées". Imprimeries-Editions Paul Brandouy. Retrieved 2025-05-15.
  5. ^ Power, F. B. (1903). "THE INTERNATIONAL CONFERENCE FOR THE UNIFICATION OF THE FORMULAE OF POTENT MEDICAMENTS". www.proquest.com. Retrieved 2025-05-15.
  6. ^ a b c d Riboulet-Zemouli, Kenzi (2025-12-31). "1925–2025: a century of international pharmaceutical law". Journal of Pharmaceutical Policy and Practice. 18 (1): 2470840. doi:10.1080/20523211.2025.2470840. PMC 11892055. PMID 40066186.
  7. ^ "Deutsches Arzneibuch : Neudruck in der Fassung der beiden Nachträge und unter Beifügung von zwei Mitteilungen des ehemaligen Reichsgesundheitsamts über kriegsbedingte Änderungen, 6. Ausgabe. ed, 1947, Deutsches Arzneibuch: amtliche Ausgabe". leopard.tu-braunschweig.de. Berlin: Arbeitsgemeinschaft Medizinischer Verlage. 1947. p. X–XI. Retrieved 2025-05-15.
  8. ^ WHO, Expert committee on specifications for pharmaceutical preparations (2008). ECSPP: Forty-second report (WHO Technical Report Series 948). Geneva: World Health Organization.
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