PharmAsia News: China Shifts Drug Recall Burden To Manufacturers In Move To Increase Accountability

SHANGHAI - China’s State FDA launched a new nationwide drug recall system Dec. 10, with an aim to set up an effective cooperative system between the government and pharmaceutical companies, and encourage them to recall unsafe drugs voluntarily.

"The new recall methods emphasize the primary responsibility of pharmaceutical manufacturers in drug safety," SFDA Spokeswoman Yan Jiangying told reporters at a Dec.12 press conference in Beijing. “Pharmaceutical manufacturers should take legal responsibility to recall bad drugs and alert the government of any reported adverse reactions caused by their drugs.”

“In the past, most drug recalls in China have been compulsory recalls issued by the government,” added Yan.

The new system is divided into three categories with different timeframes ranging from 24 hours to 72 hours, based on drugs’ respective levels of risk to health, according to Yan.

Enterprises that voluntarily recall unsafe drugs will be subject to lower, or even exempted from, administrative punishment under the new system. However, those who are aware of problems with their drugs but fail to issue voluntary recalls will face heavy fines and can even be deprived of their drug manufacturing licenses.

Under the new provisions, manufacturers will have to set up and improve their quality monitoring systems, promptly analyze information and feedback from hospitals, retailers and users, as well as investigate and evaluate potentially unsafe drugs.

The new provision also requires drug retailers and users to cooperate with manufacturers in recalling drugs.

“This is SFDA’s first ever regulation on drug recalls,” Chen Yang, a lawyer in the Beijing office of Sidley Austin, told PharmAsia News. “A recall system provides the public confidence that the government will pull back harmful products and forces the industry to put in place internal controls that may not have been present.”

Paul Li, an attorney with the San Francisco office of Squire, Sanders & Dempsey, told PharmAsia News that the new system shifts the burden of drug safety monitoring from the government to the drug makers.

“Previously, when a drug was found unsafe, the SFDA would issue a compulsory recall, which would at times mean prolonged delays in recalling the drug,” said Li. “The new regulation allows pharmaceutical companies to issue voluntary recalls on their own initiative and thus will be faster than the previous system.”

The new system will also apply to foreign companies that export drugs to China, according to SFDA’s Yan.

“Their legal obligations would be the same as domestic drug makers,” she said.

Foreign manufacturers will also have to report promptly to the SFDA, whenever they decide to recall any products outside China, added Yan.

“Multinational pharmaceutical companies will probably already have such a monitoring system in place,” said Li. “They can just continue doing in China what they have been doing abroad.”

Li added that the impact will be more significant for small and mid-size pharmaceutical companies in China.

“To establish such a monitoring system, a company will have to make substantial investments, the effects of which will be higher for smaller companies,” said Li.

– Ying Huang (pharmasia@elsevier.com)