An Update on China’s Health Product Registration Trends

January 18, 2013

Are changes in registration methods, health claims, and product approvals in China's future?

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.