China Government allows discovery firms, not just manufacturers, to launch drugs

Abstract

In a long-awaited move, China’s Food & Drug Administration (CFDA) will accept drug approval applications from the country’s drug discovery firms. So far, only drug manufacturers with plants in China have been permitted to hold the marketing rights to new drugs in the country. CFDA notes that the system that has been in place in China has discouraged innovation in the pharmaceutical sector and has led to an inefficient allocation of resources. Under a three-year pilot scheme, the agency will accept applications from research firms from 10 provinces and major cities including Shanghai and Beijing. Many in the industry expect that China will not go back to the old system. These changes will not affect foreign drug firms. “China is the only place where the manufacturer owns the rights to an active pharmaceutical ingredient,” says Kuo-Hsi Cheng, vice president of operations at ScinoPharm, a Taiwan-based producer of active pharmaceutical ingredients ...