Inside USP

US Pharmacopeia's International Activities (continued)

The Spanish translation of USP–NF USP VIII, USP IX, and USP X were translated into Spanish for distribution in Cuba, Central and South America, and the Philippines. Even with the comparatively small size of the compendia in 1910, 1920, and 1930, the translations did not sell well, partly because of regional differences in the state of healthcare development, partly because of political challenges, and partly because of these nations' historically stronger ties to Spain and Europe. USP will resume publishing USP–NF in Spanish in November 2005. The work will be a scientifically exact translation of the English version, and, like the latter, will become official on Jan. 1, 2006, with Supplements in February and June (official on Apr. 1, 2006, and Aug. 1, 2006, respectively). The challenges facing the translators were formidable, not only because of the size of the undertaking (USP 28–NF 23's folio runs to 3187 pages), but also because of the need for new terminology (e.g., how does one translate headspace sampling?) and because of regional linguistic variations. Recalling the aphorism that the UK and America are two countries divided by a common language, one can imagine that Spanish in Spain and Latin American countries is not exactly the same. To resolve technical issues, USP convened an Implementation Group that consisted of volunteers who represented various public health organizations, the pharmaceutical industry, and pharmacy schools in Spanish-speaking countries. Members were selected based on their expertise, understanding of pharmacopeial standards, and linguistic fluency. The team was responsible for translating an initial glossary of commonly used terms in USP–NF into "universal" Spanish to ensure consistency throughout the translation. Then USP contracted with an outside vendor who worked with Spanish-speaking staff and used the glossary to translate the compendia, after which the vendor performed a first-level quality-control accuracy check. A second stage of quality control involved several feedback loops with bilingual scientific liaisons from USP's Department of Standards Development and the vendor to ensure an accurate translation. In the 2005–2010 cycle, USP plans to transition the Implementation Group to an Advisory Panel working with USP's new International Health Expert Committee. On the basis of lessons learned during this process, USP is considering translating USP–NF into other languages such as Chinese, Russian, and Arabic. International harmonization Members at Convention 2005 passed Resolution 7, which calls on USP "to continue its efforts to harmonize compendial standards with the Pharmacopeial Discussion Group (PDG) and other pharmacopeias." USP has long been involved in such activities and looks forward to continuing them during the 2005–2010 cycle. At the same time, USP recognizes the resource constraints associated with harmonization and will work with all stakeholders, under the direction of the USP Board of Trustees, to determine how harmonization should proceed—now that the experiment has proceeded for approximately 15 years. Certainly the global outreach programs outlined above will lead USP to further constructive international interactions. Conclusion Space limitations prevent detailed discussion of USP's international programs, which, among other activities, include efforts with the US Agency for International Development to establish drug-monitoring programs in developing nations and work with many other international bodies, including the World Health Organization. Still, this review of USP's international standards-setting activities shows that USP's mission—promoting public health by establishing and disseminating officially recognized standards of quality and authoritative information about the use of medicines and other healthcare technologies—cannot be restricted to the United States. The need for good-quality medicines is universal, and USP is pleased to work internationally to help patients and practitioners, as well as pharmaceutical manufacturers and compounding professionals, meet this urgent need. References L. Anderson and G.J. Higby, The Spirit of Voluntarism: A Legacy of Commitment and Contribution—The United States Pharmacopeia 1820–1995 (United States Pharmacopeial Convention, Inc., Rockville, MD, 1995), pp. 70–71. Project Team 4, The Reference Standards Committee of the USP Council of Experts and Its Advisory Panel, USP Staff and Consultant, and Council of Experts Chair, "Official USP Reference Standards: Metrology Concepts, Overview, and Scientific Issues and Opportunities," submitted for publication. USP supplies reference standards to 131 countries out of the 177 countries identified by The Economist in its Pocket World in Figures (Profile Books Ltd., London, UK, 1993), p. 9. Council of Experts Executive Committee, Ad Hoc Council of Experts Committee, and USP Staff, "Development of a New Official Compendium, Separate from USP–NF, for Articles Not Legally Marketed in the U.S." Pharm. Forum. 30 (5), 1877–1883 (2004). United States Pharmacopeia staff, "USP-International: Responses to Comments on Stimuli Article," Pharm. Forum. 31 (4), in press (2005). To see a list of all the resolutions approved at Convention 2005, visit the USP Web site at http://www.usp.org/aboutUSP/resolutions.html (accessed Apr. 28, 2005). PT