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China’s New Monitoring Rules Aim to Prevent Drug Shortages

| Jan 28, 2017 09:00 AM EST

China-made detection reagent of Ebola virus is being processed on Aug. 26, 2014 in Shenzhen, Guangdong Province of China.

China will strengthen the monitoring of medicines that are prone to chronic supply shortages to ensure that they can be replenished quickly, according to new national guidelines.

The drug regulations stated in the guidelines are aimed at addressing irregularities in the production and circulation of drugs and improving its quality and efficiency, Wang Hesheng, vice-minister of the National Health and Family Planning Commission, said on Wednesday.

The guideline, which was drafted by the State Council's Health Reform Office and China Food and Drug Administration, has been approved and will be released soon, according to Wang.

He said that the new regulations will lead to improved oversight of the production of drugs and faster approval of new medicines.

The guidelines also push for the streamlining of the circulation of drugs between pharmaceutical companies and hospitals to cut down the price of drugs and regulate the increase of expenditures, Wang added.

Reports of shortages of commonly used medicines, including essential ones, in many parts of China have stirred public interest in the country in recent years.

Protamine sulfate, an injection needed for life-saving operations including heart surgeries, made headlines in April after it was reported that the drug was in short supply in many areas of China, forcing several hospitals to temporarily suspend heart surgeries.

The National Health and Family Planning Commission responded in May that Chinese pharmaceutical companies have halted production of the drug at the end of 2015 due to new drug laws in China, causing the shortage.

Measures to encourage production of the drug were undertaken so that it can be supplied immediately to the market, the commission said in a statement in May.

Wu Zhen, head of the China Food and Drug Administration, told Xinhua on Wednesday that many of the medicines that are in short supply are for children.

Guo Xiang, deputy director of consumer goods at the Ministry of Industry and Information Technology, said the ministry has chosen seven kinds of drugs for children's use and has authorized pharmaceutical companies since last year to produce them to ensure a steady supply.

The ministry has invested 80 million yuan last year to help increase the supply of paediatric medicines, he said.

Fu Mingzhong, executive president of the China Association of Pharmaceutical Commerce, said a national data platform on the monitoring of drugs will certainly address China's drug shortage.

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