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Address:
377 Saw Creek Estates,
Bushkill, PA18324, USA
Tel: +1 570-588-3854
Fax: +1 702-995-3905
+1 570-588-3213
Email:
info@pharmachinaonline.com |
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| Name: |
MOU on Food and Drug Quality by USP and CP |
| Type： |
Other |
Issuing
Agency ： |
Other |
| Categories： |
Drug Safety/ADR |
Effective
Date: |
2008-03-05 |
Withdraw/
Expiry Date: |
n/a |
| Summary： |
The U.S. Pharmacopeial Convention (USP) and the Chinese Pharmacopoeia Commission (CPC) signed a Memorandum of Understanding (MOU) in March 2008 with the purpose of working together to strengthen the quality of medicines and foods in the United States and China.
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 CPC 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 CPC 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 CPC will explore ways to expedite the translation of USP compendia into Chinese. Conversely, USP and CPC 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 CPC 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 CPC have maintained a strong working relationship since 1990, when USP staff first visited CPC. Since then, the organizations have co-sponsored two scientific meetings and signed an initial MOU in 2005, which laid the foundation for further cooperation. |
Additional
Info/Comments: |
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. CPC 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. |
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