U.S., China Signs Import Agreement on Safety of Drugs and Medical Devices

December 18, 2007

On Tuesday, December 11, 2007, China and the United States signed two agreements in an effort to ensure that food, drugs, medical devices and animal feed imported into the U.S. from China meet U.S. Safety Standards.  The two agreements were signed at the end of a meeting of the China U.S. Joint Commission on Commerce and Trade by Li Changjiang, head of the General Administration of Quality Supervision, Inspection and Quarantine and U.S. Health Secretary Mike Leavitt. 

The agreements follow a series of recalls that raised concerns about Chinese goods that have been imported at a significantly increasing rate, including medical devices.  Exports of Chinese-made scientific, medical and hospital equipment to U.S. has expanded to approximately $1.87 billion in 2006 and exports of Chinese medicinal, dental and pharmaceutical preparations totaled $676 million. 

The Safety of Drugs and Medical Devices agreement would impose new registration and certification requirements on imported Chinese drugs, active ingredients in pharmaceuticals and medical devices to avoid counterfeiting and safety problems.  The agreement covers the following drugs and medical devices that are manufactured in China and exported to the United States: gentamicin sulfate (an antibiotic), atorvastatin (a cholesterol-lowering drug), sildenafil (a drug for erectile dysfunction), dietary supplements intended for erectile dysfunction, human growth hormone, oseltamivir (an antiviral product), and cephalosporins (a class of antibiotics) manufactured in facilities that also manufacture non-cephalosporin drugs, glycerin, glucose test strips, and condoms. 

The agreements call for all Chinese producers of these drugs and devices to register with the Chinese government.  The two countries then plan to work together to develop and implement a program to certify that those items exported to the United States meet U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) safety standards.  HHS/FDA and State Food and Drug Administration (SFDA) of the People’s Republic of China will exchange information on drugs and devices to better ensure product safety.   In the past, there was no formal system of notification between regulators in the two countries, but now SFDA will notify HHS/FDA within 24 hours of any determination that a product sent to the United States could cause serious adverse health consequences.  Within this notification, China will also provide the tracking information necessary to identify the shipment and supplier.

The agreement, while still in need of much work to set up a system to carry out its provisions, is definitely a start to address the increased concerns of the American public.  The U.S. foresees using this agreement as the model of future agreements to be signed by other countries. 

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