BEIJING — American and Chinese regulators signed an agreement Tuesday to strengthen regulation of drugs and medical devices exported to the United States. But the accord covers only a tiny fraction of the pharmaceutical ingredients being marketed worldwide by thousands of unlicensed chemical companies.
The agreement, one of a series of trade accords signed Tuesday, followed nearly seven months of negotiations, during which American officials asked China to stop unlicensed chemical companies from exporting bulk pharmaceutical ingredients, some of which were ending up in the United States.
Under the accord, all Chinese companies that make certain drug products for export to the United States will be required to register with Chinese regulators. Among the most important of those drugs are atorvastatin, the generic name for the cholesterol-lowering drug Lipitor; sildenafil, the generic name for Viagra; and the antibiotic gentamicin sulfate.