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US, Kazakhstan to share standards for quality of medicines

Rockville, Md., October 25, 2010 With the mutual goal of improving the quality of pharmaceuticals worldwide, the United States Pharmacopeial Convention (USP) and the Republican State Enterprise (RSE) National Centre for Expertise of Drugs, Medical Products and Equipment ("the Centre") of the Ministry of Health of the Republic of Kazakhstan 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 State Pharmacopoeia of the Republic of Kazakhstan. 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 Kazakhstan ("adapted").

The agreement was signed by Dr. Roger L. Williams, USP's chief executive officer, and Dr. Larissa Pak, deputy chair, Committee on Surveillance of Medical and Pharmaceutical Activities of the Ministry of Health of the Republic of Kazakhstan, today at the RSE in Almaty, Kazakhstan.

According to USP's Dr. Williams, "Promoting public health internationally is an important goal for the Centre and for USP. The scientific exchange represented by this agreement will serve to benefit the citizens and manufacturers of Kazakhstan. USP will benefit from the experience of the Centre's scientists, which in turn contributes to the strength and relevance of the standards published in the USPNF."

Dr. Pak concurred: "Collaboration activities among national pharmacopeias serve to benefit public health on an international scale. As pharmaceuticals continue to be sourced and distributed across international borders, scientific exchange will play an increasingly important role in ensuring the quality of medicines worldwide." Beyond the use of USPNF written, documentary standards, the 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. Officials from USP and the Centre have 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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