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USP Convention and Chinese Pharmacopoeia Commission sign Memorandum of Understanding

Rockville, Md., March 6, 2008 The U.S. Pharmacopeial Convention (USP) and the Chinese Pharmacopoeia Commission (ChP) this week signed a Memorandum of Understanding (MOU) with the purpose of working together to strengthen the quality of medicines and foods in the United States and China.

Roger L. Williams, M.D., USP executive vice president and CEO, and Wu Zhen, secretary-general of ChP and deputy commissioner of Chinas State Food and Drug Administration (SFDA), signed the MOU at USPs Headquarters in Rockville, Md. A Chinese delegation of representatives from the ChP and the SFDA joined Mr. Wu in visiting USP.

USP is pleased to partner with the Chinese Pharmacopoeia Commission on this Memorandum of Understanding, said Dr. Williams. This agreement represents our combined commitment to improving patient care and advancing the public health in the United States and China through rigorous quality standards for medicines. The agreement is a renewal of a prior agreement that had been in place for several years.

The Chinese Pharmacopoeia Commission looks forward to a long-term relationship with USP in which we exchange our scientific expertise and work together on a variety of activities that will benefit all consumers of medicine in our respective countries, added Mr. Wu.

Potential areas of collaboration identified in the MOU include:

  • Standards In order to strengthen documentary and physical standards which assure the quality of medicines, foods and other health care products USP and ChP will develop processes to update existing monograph standards and acquire new monographs.
  • Third-Party Certification (Verification) To advance the availability of good quality pharmaceutical ingredients used to produce medicines in China and the United States for export, USP and ChP will explore ways to develop approaches to allow review, testing and audits of manufacturers of ingredients imported into China and those manufacturing for export from China to the United States.
  • Translation To assure the availability and use of USP compendia among Chinese-speaking people, USP and ChP will explore ways to expedite the translation of USP compendia into Chinese. Conversely, USP and ChP will consider ways for USP to review the quality of the English translation of the Chinese Pharmacopoeia.
  • Working Relationships To facilitate knowledge exchange, USP and ChP will hold a joint scientific symposium biannually alternating between the United States and China; hold meetings between senior management of both groups at least once a year; and exchange scientific staff.

USP and ChP have maintained a strong working relationship since 1990, when USP staff first visited ChP. Since then, the organizations have co-sponsored two scientific meetings and signed an initial MOU in 2005, which laid the foundation for further cooperation.

USP sets federally recognized standards for the quality, purity and strength of prescription and over-the-counter medications sold in the United States, as well as widely recognized standards for dietary supplements and food ingredients. ChP holds legal responsibility in China for creating and revising national medicine standards, including traditional Chinese medicines (TCM). Some TCM products may be considered both drugs in the United States and dietary supplements.


Contact: Sandra Kim
US Pharmacopeia

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