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US, Ukraine agree to share standards for quality of medicines

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 PharmacopeiaNational Formulary (USPNF) in the Ukraine Pharmacopoeia and its companion journal, Pharmacom. The standards may either be included entirely as they are published in the USPNF, 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 USPNF."

Dr. Gryzodoub concurred: "The ability to utilize quality standards from the USPNF 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 USPNF 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.


Contact: Francine Pierson
US Pharmacopeia

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