An Update on China’s Health Product Registration Trends

China’s State Food and Drug Administration (SFDA) is mulling several actions that would likely affect its dietary supplements market, reports the U.S.-China Health Products Association (USCHPA).

USCHPA says that the SFDA is intent on decreasing its total number of health product registrations, both domestic and foreign, by “close to 50%” with a target around 300 products. Product registrations, however, have shifted in favor of domestic products in recent years. A USCHPA chart covering registrations from the past 17 years provides the evidence.

“The association created this chart because this information is only available from China's SFDA in Chinese and is a good measuring stick for foreign companies to judge just how many foreign companies are getting registrations-which is, sadly, very few,” explains Jeff Crowther, USCHPA executive director. “This is not because [the companies] fail to get [registrations]; it is more often the case that foreign companies look to import their products under the food category and not under the health food category."

He continues, "This is because importing a product as food requires a smaller investment [than importing a product in] the health food category. Many of the companies that make up the global dietary supplement industry are small- to medium-sized enterprises and do not have the resources to invest hundreds of thousands of dollars just to get into a market [the health product market], which [currently is the amount of money] needed to enter under SFDA's health product registration system.”

USCHPA adds that China will be looking to simplify the registration process for single-ingredient products that traditionally require expensive, multiyear registration labor. Allowable health claims could also decrease from 27 to 18, according to reports of ongoing draft regulations.