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China bans imports of ROK medical product

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(Globalpost/GlobalPost)

BEIJING, Dec. 9 (Xinhua) -- China's drug watchdog has banned imports of a set of antibiotic injection products manufactured by a Republic of Korea (ROK) pharmaceutical company due to its refusal to accept spot checks.

According to a statement issued by the China Food and Drug Administration (CFDA) on Monday, the body has ordered all ports to stop importing cefmetazole produced by the ROK's Daewoong Pharmaceutical Co.,Ltd.

The statement quoted an unnamed CFDA official as saying that the administration plans to inspect the production facilities of some imported goods, including Daewoong Pharmaceutical's cefmetazole, in order to strengthen management of such products, a policy which is in line with the CFDA's annual arrangements.

However, Daewoong Pharmaceutical did not accept checks according to a prearranged schedule.

The CFDA therefore decided to ban its cefmetazole until it can make sure the product meets Good Manufacturing Practice (GMP) standards after conducting spot checks, the official said.

Implementing GMP standards is a credible measure to ensure the quality, safety and efficiency of drugs, he added.

Drugs sold in China must meet the standards of the country's drug manufacturing quality norms and be subject to the supervision of China's drug regulator.

Drug manufacturers that refuse or fail the examination will be severely dealt with according to the law, according to the official.

Daewoong Pharmaceutical aims to "become the top pharmaceutical company in Eastern Asian countries" in 2015, according to its official website.

http://www.globalpost.com/dispatch/news/xinhua-news-agency/131209/china-bans-imports-rok-medical-product