The International Pharmacopoeia
The WHO's pharmacopoeia — free, online, and focused where global public health needs it most: quality specifications for the medicines on the WHO Model Lists of Essential Medicines, including treatments for HIV, tuberculosis, and malaria, plus the general methods to test them. The 12th Edition (2025) is the current release. The Ph. Int. is legally binding wherever national or regional legislation references it, and it is the compendial reference of the WHO Prequalification Programme.
What this does not cover
stated in the document's own scope- Covers medicines of public-health importance, prioritising the Essential Medicines Lists — it does not attempt the market-wide coverage of the USP or Ph. Eur.
- Not binding of itself: legal force arises only where national or regional legislation references it, or through prequalification requirements.
- Sets product standards; manufacturing practice belongs to the WHO GMP texts (e.g. TRS 986 Annex 2), a separate part of the WHO norms system.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The International Pharmacopoeia (Ph. Int.) is the WHO's compendium of quality standards — free, online, and deliberately focused on the medicines that matter most to global public health: the substances and dosage forms on the WHO Model Lists of Essential Medicines, with strong coverage of treatments for HIV, tuberculosis, malaria, and other priority diseases. The current release is the 12th Edition (2025). Monographs carry specifications for pharmaceutical substances and finished dosage forms, supported by general methods of analysis, general notices, and the International Chemical Reference Substances that anchor its tests. Its purpose is service: to give any WHO Member State a scientifically maintained compendial standard it can adopt or reference without cost.
Scope & applicability
Pharmaceutical substances and dosage forms of public-health importance, offered for adoption or reference by any WHO Member State. It acquires legal force through national reference — many regulators in low- and middle-income markets adopt it directly — and operationally through WHO prequalification.
Legal basis & how it acquires force
Prepared by the WHO Expert Committee on Specifications for Pharmaceutical Preparations and published by the WHO. The Ph. Int. has no inherent legal force: it becomes legally binding wherever a national or regional authority references it in legislation — which many regulators in low- and middle-income markets do — and it operates as the default compendial reference of the WHO Prequalification Programme, through which medicines qualify for UN procurement.
Document structure
| Part | Covers |
|---|---|
| General notices | The interpretive rules for applying monographs and methods |
| Monographs for pharmaceutical substances | Identity, purity, and assay specifications for active substances |
| Monographs for dosage forms | Specifications for finished preparations, including priority-disease treatments |
| Methods of analysis | The general analytical methods, physical and chemical, that monographs invoke |
| International Chemical Reference Substances | The reference materials prescribed by the monographs |
Key requirements
- Articles covered by a Ph. Int. monograph meet its specification where the compendium is the referenced standard
- Testing per the Ph. Int. general methods of analysis, interpreted through its general notices
- Use of International Chemical Reference Substances (ICRS) where monographs prescribe them
Implementation tips
- For products entering WHO prequalification, cite the Ph. Int. monograph where one exists — it is the assessment team's default compendial reference, and it is free, which matters for multi-market dossiers
Revision notes
The 12th Edition was released in 2025, continuing the free online publication model. Editions are updated on a rolling basis as the WHO Expert Committee adopts new and revised monographs.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The Ph. Int. complements rather than competes with the USP, Ph. Eur., and JP: its selection criterion is public-health importance, not market coverage, and its methods favour techniques feasible in resource-limited laboratories. It is the compendial arm of the same WHO norms system that produces the WHO GMP texts (TRS series) and underpins prequalification — a dossier citing Ph. Int. monographs plugs directly into WHO assessment.
Ph. Int. (12th ed.): frequently asked questions
Quick answers to common questions about Ph. Int. (12th ed.).
What is the current edition of The International Pharmacopoeia?
The 12th Edition, released in 2025 and published free online — the Ph. Int. is updated on a rolling basis as the WHO Expert Committee adopts new and revised monographs.
Is The International Pharmacopoeia legally binding?
Only where adopted: it has legal status whenever a national or regional authority references it in legislation, and many regulators do exactly that. Elsewhere it serves as a freely available reference standard, and within WHO prequalification it is the default compendial benchmark.
How does the Ph. Int. differ from the USP or Ph. Eur.?
Selection and accessibility. The Ph. Int. concentrates on medicines of global public-health importance — essential medicines and priority-disease treatments — rather than whole-market coverage, its methods are chosen with resource-limited laboratories in mind, and it is free, where the major national and regional compendia are sold.
What are International Chemical Reference Substances?
The WHO-established reference materials (ICRS) that Ph. Int. monographs prescribe for identification and assay — the compendium's equivalent of USP Reference Standards, distributed through the WHO custodian centre.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.