In a move consistent with policy changes in China to ease up on drug approval regulations, the country’s Center for Drug Evaluation (CDE) released a list of 48 drugs—already approved outside of China—that it hopes to make eligible for expedited clearance. The drugs, most of which are treatments for rare diseases or for the prevention and treatment of life-threatening diseases, have been deemed clinically urgent.
The drugs targeted by the CDE include Merck’s anti-PD-1 therapy Keytruda and Amgen’s cholesterol therapy Repatha, and Gilead Sciences HIV therapy Genvoya.
Because speedy clearance is a priority, the CDE is focusing its efforts on drugs approved in Europe, Japan, or the U.S. that won’t require additional studies to be conducted in China. Instead, true to an announcement made last year, China says companies can submit the drugs for regulatory approval using data from overseas markets if it is believed there are no safety or efficacy differences across ethnicities.
(Source: The Wall Street Journal; Bloomberg)
