Caixin: US Approval Offers Shot in the Arm to China’s Traditional Medicine

Traditional medicines, once customized for each patient, are increasingly standardized and manufactured in large modern factories, for delivery around the globe. To expand markets, Chinese manufacturers are conducting clinical trials and putting their products under the review of the US Food and Drug Administration, considered among the world’s toughest regulators for drugs. “Although China started its TCM export campaign in the 1990s, no TCM product has ever won FDA approval to be marketed as a drug in the U.S.,” reports Coco Feng for Caixin. “Although the industry has encountered serious questions about quality and standardization, some of its products have made inroads in other counties. Still, U.S. FDA approval remains the holy grail for TCM makers because it would serve as an endorsement by the Western medical establishment and crack open lucrative pharmaceutical markets – not only in the U.S., but elsewhere around the world.” Chinese products are distributed as prescription drugs in Russia, Singapore, Vietnam, the Philippines and some countries in Europe. FDA approval requires three phases of testing on safety and efficacy followed by agency review, and quality control is a challenge for drugs made of herbs and plants with varying levels of active ingredients depending on growing conditions. – YaleGlobal