As of October 12, 2017
The Global Health Standards (GHS) Program collaborates across stakeholders to prioritize, develop, disseminate and enable adoption of USP’s Global Health Monographs. The GHS Program collaborates with and receives input from external stakeholders, including global health experts, regulators, and pharmaceutical industry thought leaders.
Monographs give scientists, governments, manufacturers, and others a public standard by which to judge an article’s quality. Global Health monographs are defined as “official USP monographs for articles which are not currently legally marketed in the United States, but which have been approved by a stringent regulatory authority”*. Global Health monographs provide public standards for medicines that are considered essential medicines in other parts of the world.
*Stringent regulatory authority (SRA) as defined by the World Health Organization - A regulatory authority which is: (a) a member of the International Conference on Harmonisation (ICH) (as specified on www.ich.org); or (b) an ICH observer, being the European Free Trade Association (EFTA), as represented by Swissmedic and Health Canada (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement including Australia, Iceland, Liechtenstein and Norway (as may be updated from time to time).] [See WHO ECSPP Technical Report Series 961. http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf page 391]
USP’s mission is to improve global health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. The GHS Program responds to the urgent unmet need for public standards for medicines that are crucial to communities outside the US. For instance, currently >20% of medicines on the World Health Organization’s Model List of Essential Medicines lack modern pharmacopeial standards. This is particularly dangerous because without a monograph, the uniformity, consistency, and quality of ingredients and healthcare products cannot be assured. A large number of crucial, and often lifesaving medicines for diseases such as malaria, tuberculosis, HIV/AIDS, neglected diseases, and maternal-child health conditions are not sold in the United States, but are still an integral part of the medicines ecosystem. Developing public standards for these medicines is essential to safeguarding global public health and consistent with USP’s mission.
Global Health monographs are differentiated in three key ways from other USP-NF monographs.
- Placement: Global Health monographs are published in a separate section of the USP-NF.
- Preface: A preface to the Global Health monographs section clearly specifies the regulatory status in the US of the articles published in that section.
- In text definitions: Individual monograph definitions also provide a statement to clearly indicate that the article has not been reviewed for efficacy and safety by the United States Food and Drug Administration (FDA).
GH monograph development uses the existing collaborative and transparent USP-NF monograph development processes, including proposal in the Pharmacopeial Forum (PF), and expert committee review and approval. As mentioned above, the selection and prioritization of new Global Health monographs will be done by an advisory group comprising of experts/stakeholders in the global health community to ensure these are relevant, modern standards for the world’s most essential medicines.
If a Global Health monograph article gains approval to be marketed in the US by the FDA, USP will omit the Global Health monograph and take steps to develop a USP-NF monograph for the FDA-approved article.