The FDA will open a 13-member branch office in the US embassy in Beijing, the first foreign-located branch for the agency. The new office will attempt to prevent China-related safety problems before they happen. The safety problems are critical because China is the number one supplier of APIs to the US. More details...

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The authors continue to examine the proposed changes in China patent law, bringing readers up to date by focusing their attention on the differences between Draft Revision 2008 and Draft Revision 2006.  They find four major issues undergoing change: Willful infringement, misuse of patent rights and unfaithful accusation, inventions made in China, and empowerment of patent administration. A previous article covered the first two topics (see article). Here, the authors discuss inventions made in China and empowerment of patent administration. More details...

Last week, for two days the NIH held a Research Roundtable on traditional Chinese medications, where US and China scientists discussed TCM. At the outset, the US and China signed a Memorandum of Understanding that will set up a collaboration to further scientific research into TCM. The MOU was signed by the Secretary of HHS, Mike Leavitt, and the Chinese Vice Minister of Health, Wang Guoqiang. The MOU acknowledged that “alternative” medical practices are already a part of many Americans’ health practices. Leavitt said the new initiative will help us understand how “to appropriately integrate traditional Chinese medicine with Western medical approaches.” More details...

China has agreed to allow the FDA to open three inspections offices in China by the end of 2008. The offices will be placed in Beijing, Shanghai and Guangzhou, according to Mike Leavitt, Secretary of the US Department of Health and Human Services. The offices will house between nine and twelve staff members. Leavitt positioned the move as more than a safety watchdog operation. More details...

Six patients, each of whom had been given human immunoglobulin from a specific batch manufactured by Jiangxi Yabo Bio-pharmaceutical, died in the few days following May 22.  Although drug-caused death seems a familiar story, the one had a new twist: the SFDA was very quick to follow up, identify the likely cause, and remove the remaining examples of the batch from the supply chain.  More details...

China Sky One Medical, Inc. reported it received SFDA approval for five new patch products, most of them using natural herbs as their active ingredients. They include an Anti-smoking patch, a Scar patch, a Migraine patch, an Eye patch and a Coronary heart disease patch. More details... 

Stock Symbol: (AMEX: CSY)

The SFDA will soon introduce new rules that will speed up the IND process for innovative drugs in China. The new procedures will not, apparently, change overall IND standards. However, the SFDA will establish guidelines that distinguish innovative drugs, especially those for unmet needs, from less significant submissions. These innovative INDs will receive first priority at the SFDA and result in a speedier ruling, though the SFDA did not declare a specific target for IND turnaround time. More details...

As expected, the Ministry of Health (MOH) has been reorganized and now will assume administrative responsibility for the SFDA. For the past five years, the SFDA has been operating as an independent agency. Before that, the SFDA was part of the MOH. The plan to reorganize the Ministry of Health was presented to the State Council on March 11 by Jianmin Hua, Secretary General of the State Council. He said the goal of the reorganization was to establish clear lines of responsibility for food and drug surveillance. More details...

The FDA and Baxter International announced today that a heparin-like molecule found in Baxter’s supplies of heparin may be the culprit in the recent wave of heparin-caused side effects. Baxter, which produces half of the US supply of heparin, has recalled all of its heparin products. Between 5% and 20% of the raw material sampled seemed to be contaminated. The brouhaha has caused a call for more and better FDA inspections of foreign-sourced drugs and APIs, but that may be difficult to achieve.  More details...

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According to unofficial reports, the State Government of China will spend a huge 4 billion RMB ($548 million) over the next five years to stimulate development of innovative drugs in China. Another 7 billion RMB ($966 million) will be allocated in the following 10 years. These funds are in addition to existing programs. The State Council, China’s cabinet, is said to have approved the initiative on December 28, 2007, but as yet, it has not made a formal announcement of the program. More details...