Public Release: 

US, Ukraine agree to share standards for quality of medicines

Pharmacopoeias of both nations sign accord that benefits public health

US Pharmacopeia

Rockville, Md., June 2, 2010 -- With the mutual goal of improving the quality of pharmaceuticals worldwide, the U.S. Pharmacopeial Convention (USP) and the Ukraine Scientific Pharmacopoeial Centre for the Quality of Medicines (the Centre) have entered into an agreement to share standards for the quality, purity, strength and identity of medicines. Specifically, the Centre will have a five-year, renewable right to include written standards from the United States Pharmacopeia-National Formulary (USP-NF) in the Ukraine Pharmacopoeia and its companion journal, Pharmacom. The standards may either be included entirely as they are published in the USP-NF, in translation ("adopted") or modified to better suit the Centre's requirements for the Ukraine ("adapted").

The agreement was signed by Roger L. Williams, M.D., USP's chief executive officer, and Oleksandr Gryzodoub, Ph.D., director of the Ukrainian Centre, today at USP's headquarters in Rockville, Md.

According to USP's Dr. Williams, "This agreement is a milestone in helping to promote public health internationally. The scientific exchange represented by the agreement with the Centre will benefit not only the citizens of the Ukraine but also Ukrainian manufacturers wishing to export to other countries. USP will benefit from the experience of the Centre's scientists, which in turn contributes to the strength of the standards published in the USP-NF."

Dr. Gryzodoub concurred: "The ability to utilize quality standards from the USP-NF will contribute to the health of the people of Ukraine and the region. Partnership with USP will give the Ukraine Pharmacopoeia access to internationally recognized quality standards." Beyond the use of USP-NF written, documentary standards, the Ukrainian Centre will explore opportunities to use USP's accompanying reference standards, which are physical or chemical "yardsticks" by which pharmaceutical manufacturers and regulators measure the quality and identity of medicines. USP and Centre officials have exchanged visits and held several high-level meetings over the past year exploring opportunities for cooperation, culminating in this new agreement.

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USP is a scientific, nongovernmental organization that sets standards for the quality, purity, strength and identity of medicines, food ingredients and dietary supplements. USP's written drug standards are enforceable in the United States by the Food and Drug Administration. As part of its mission to improve the health of people around the world through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods, USP has formed many working partnerships with public health-focused organizations in all parts of the globe.

For more information, please contact mediarelations@usp.org.

USP--Advancing Public Health Since 1820

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are recognized and used worldwide. For more information about USP visit http://www.usp.org.

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