The U.S. Department of Health and Human Services (HHS) and the State Food and Drug Administration (SFDA) of the People’s Republic of China yesterday signed a memorandum of agreement to enhance the safety of drugs, excipients, and medical devices exported to the United States from China. The agreement was signed in Beijing by HHS Secretary Mike Leavitt and SFDA Commissioner Shao Mingli.
Specifically, the two countries are establishing a bilateral mechanism to help ensure these imported products meet standards for safety and effectiveness by building quality into the process from the start. SFDA will require firms that manufacture certain products intended for export to the United States to register with SFDA. SFDA will also work toward a system that will enable it to certify that firms that manufacture products, and the products themselves, meet HHS/Food and Drug Administration requirements.
Among the drugs covered by the agreement are certain antibiotics, human growth hormone, glycerin, glucose test strips, and condoms. Read the press release.
