USP
Convention and Chinese Pharmacopoeia Commission
Sign Memorandum of Understanding
Agreement Will Strengthen Collaborative
Efforts to Improve the Quality and Safety
of Medicines and Foods in Both Countries
Rockville,
Md., March 6, 2008. The U.S. Pharmacopeial
Convention (USP) and the Chinese harmacopoeia
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, USP executive vice president and CEO,
and Wu Zhen, secretary-general of ChP and deputy
commissioner of China's State Food and Drug Administration (SFDA),
signed the MOU at USP's 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.
For
more information, please email mediarelations@usp.org.
USP
Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a private, non-profit,
standards-setting organization that advances public health by
ensuring the quality and consistency of medicines, promoting
the safe and proper use of medications, and verifying ingredients
in dietary supplements. These standards, which are recognized
worldwide, are developed by a unique process of public involvement
through the contributions of volunteers representing pharmacy,
medicine, and other health care professions, as well as science,
academia, government, the pharmaceutical industry, and consumer
organizations. For more information about USP and its four public
health programs, visit www.usp.org/newscenter.