ROCKVILLE, MD (January 10, 2005) — The U.S. Pharmacopeia (USP) has announced a collaborative research agreement with Health Canada’s Health Products and Food Branch Inspectorate. The agreement became effective on September 7, 2004, and will remain in effect until March 2007. USP provides authoritative drug standards in the United States Pharmacopeia (USP) and National Formulary (NF) and official USP Reference Standards that are recognized worldwide.
Ronald G. Manning, Ph.D., USP’s vice president of monograph and reference standards development, and L. Valentin Feyns, Ph.D., a scientific fellow at USP, visited the Health Canada laboratories near Montreal after the finalization of the agreement to discuss its pending implementation. “We view the agreement with Health Canada as a significant step towards providing high quality standards for medicines produced globally,” said Dr. Manning.
Health Canada laboratories will assist in the testing and characterization of candidate (proposed) reference standards as part of the USP Reference Standards Development Process. Results of the testing will be included in the reports submitted to USP’s Reference Standards Committee for final approval. Although Canadian experts have been involved in the Reference Standards program almost from its inception, (and one Health Canada expert is currently a member of the USP Reference Standards Committee) this collaborative agreement marks the first time Health Canada has been formally involved in one of the most important programs at USP.
Diane C. Gorman, Assistant Deputy Minister at Health Canada commented, “I am pleased to see the long-standing collaboration between our scientists formalized with this agreement. This project will help to ensure the availability of USP Reference Standards used for testing the quality and safety of drugs in Canada, the U.S. and throughout the world.”