Western Europe

Responding to the growing needs of a global pharmaceutical marketplace, USP opened its first international location, the Europe/MENA office, in 2005 in Basel, Switzerland. The location offers USP greater access to European pharmaceutical and foods industries, as well as European-based international public health organizations, who share in USP’s mission to improve global public health. Learn more about the USP Europe/MENA office and the services it offers.

Collaborations

Memorandum of Understanding (MOU)

USP signed an MOU with the National Biological Standards Board, which manages the National Institute for Biological Standards and Control of the United Kingdom to help improve and harmonize quality standards for biological medicines.

Other Government & Association Activities

• USP and the European Directorate for the Quality of Medicines & HealthCare/Council of Europe (EDQM) and USP, along with Japan’s Pharmaceuticals and Medical Devices Agency (PDMA), meet regularly to promote harmonization of pharmacopeial standards through the Pharmacopoeial Discussion Group (PDG). Responding to the crisis involving adulteration of heparin, members of PDG cooperated on improved quality standards for heparin and launched workshops to address further improvements. Learn more about USP’s harmonization efforts and PDG.
• USP’s commitment to the Geneva, Switzerland-based World Health Organization (WHO) is exemplified by its continuing work with two key WHO committees—the Expert Committee on Biological Standardization and the Expert Committee on Specifications for Pharmaceutical Preparations. USP routinely provides comments to WHO that relate to WHO’s International Pharmacopoeia standards.
• In 2009, USP filed an application for formal nongovernmental organization observer status to attend meetings of the Codex Alimentarius Commission, which sets standards for foods and food additives in Europe. Pending acceptance of this application, USP has participated via membership in the FDA delegation and other organizations in CAC meetings and meetings of specific CAC committees: Food Additives, Contaminants in Food, Committee on Methods of Analysis, and Nutrition and Foods for Special Dietary Uses. The Joint WHO/FAO Expert Committee on Food Additives (JECFA) produces a compendium of food additives that is, in some aspects, similar to FCC.
• USP participated in meetings of the Consultative Committee for Amount of Substance (CCQM), a committee of the International Bureau of Weights and Measures which is responsible for chemical metrology relevant to USP’s monograph standards where measurements are in mass. USP also participated in three pilot Key Comparisons via the Bioanalytical and Organic Analytical Working Groups, and participated actively in the Joint Committee for Traceability in Laboratory Medicine. USP organized and co-sponsored a Workshop on Measurement Traceability for Pharmaceutical and Bio-pharmaceutical Measurements, held at BIPM in France in 2008.

Events

• USP User Forums are periodically held throughout Europe, providing users with updates on USP’s standards and helping ensure the appropriate use of those standards. Events have been held in London, Madrid, Milan, Berlin, Frankfurt, Paris, and Dublin. View upcoming User Forum information.
• USP continues to promote the effective interpretation and application of USP standards through Pharmacopeial Education courses. The USP staff from the Europe/MENA office has been instrumental in delivering programs in Austria, Belgium, Denmark, France, Germany, Ireland, Spain, Switzerland, and the United Kingdom. View the latest online and classroom course offerings.

Convention & Volunteer Representation

These Western European countries have members and/or observers to the U.S. Pharmacopeial Convention, and/or citizens who serve as USP Expert Volunteers. [KEY: M–Members, O–Observers, EV–Expert Volunteers]