HHS and Chinas State Food and Drug Administration have signed an agreement to increase regulation and inspection of Chinese-manufactured drug and medical devices exported to the U.S.
Under the agreement, China and the U.S. will establish a bilateral mechanism for ensuring that drugs and medical devices imported from China meet safety and efficacy standards, according to an HHS news release. Steps include building quality measures into early-stage production of medical products; requiring mandatory registration and certification of Chinese manufacturers and their facilities with Chinas SFDA; providing FDA officials with greater access to inspect Chinese manufacturing plants; and creating an electronic tracking system that will follow goods from the point of manufacture to export.
The agreement targets better regulation of a specific list of medical devices and drugs manufactured in China for export to the U.S., including the antibiotic gentamicin sulfate, the cholesterol-lowering drug atorvastatin and the antiviral oseltamivir.
The memorandum of agreement, signed by HHS Secretary Mike Leavitt and SFDA Commissioner Shao Mingli in Beijing, is the result of five months of negotiations, which began following a series of product safety lapses on pet food, drugs, toys and other goods imported from China. For more on this subject, click here. -- by Shawn Rhea