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China approves plan to vouchsafe drug safety

By Wang Xiaodong  (China Daily)

08:20, December 08, 2011

BEIJING - The State Council approved a blueprint on Wednesday to establish a credit rating system and intensify monitoring of pharmaceutical groups to boost the country's drug safety over the next five years.

"Our country's pharmaceutical companies are experiencing various problems such as the lack of an integrated credit system, inadequate supervision and a weak technical foundation. Medicinal safety is in a high-risk stage," according to a statement released on Wednesday after a State Council executive meeting presided over by Premier Wen Jiabao.

The 2011-2015 plan set the general goal of "sharply" increasing the safety level and people's satisfaction with drugs by ensuring that all pharmaceutical products meet the standards of a newly revised regulation on medical product quality management by the end of 2015, the statement said.

Authorities should speed up digitalization of drug supervision. Unified code management for approved drugs should be adopted and electronic supervision should cover all types of drugs, according to the plan.

Authorities should intensify safety monitoring and early-warning capabilities, and safety monitoring and evaluation should be focused on new medicines, traditional Chinese medicine injections and high-risk medicines. Emergency planning should be improved to ensure a timely and efficient supply of medicines for emergencies, the document said.

More efforts should be spent on innovation in medicine law enforcement, regulating the paths of distribution of medicines and reducing the middlemen in distribution. The formulation and updating of laws and regulations concerning medicine management should be accelerated, according to the plan.

To ensure medicine safety, the Ministry of Public Security concluded a campaign on Nov 17, which resulted in some 1,280 investigations across 170 cities in 29 provinces and autonomous regions.

Li Dakui, deputy director of the Chinese Pharmaceutical Association, said it is timely that the meeting has put speeding up digitalized supervision on the agenda. "Unified code management is crucial to effective supervision of drug production and distribution. It can regulate the distribution and keep track of services for drug distribution," he said.

"Code management is a universally adopted practice in medicine. China should have adopted this practice long ago."

The high cost of drugs has been a public nuisance in China, partly due to excessive middlemen in the distribution. In a move to reduce people's medical bills China lowered the retail price ceiling of 82 kinds of pharmaceutical drugs by an average 14 percent on Sept 1.

"Currently, there are too many links and irregularities in medicine distribution," said an industry insider who asked to remain anonymous.

"The price of a medicine in a pharmacy may be 10 times or even higher than its factory price due to excessive distribution."

"Because now China generally has an oversupply of medicines, to ensure the safety of medicine has become even more urgent."

Xinhua contributed to this story.

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