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State FDA (SFDA), Ministry of Science and Technology (MOST), Minsitry of Health (MOH) and other China government agency policies and regulations and how they impact the industry...

Recent Articles

Beijing FDA Speeds Up its Fast-Track Review Jan 31, 2012: To promote the research and registration of innovative therapeutics in Beijing, the Beijing FDA has issued a new set of guidelines for fast-track status, effective February 12, 2012. The new set of rules mandate a review time of just 15 working days, down from 30 working days under the previous guidelines. Also, seven categories of drugs now qualify for fast-track status in Beijing, against four categories of eligible candidates in the national-level SFDA. More details....

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China Announces Major Program for Biotechnology 2010-2020 Jan 5, 2012: To establish itself in the global front rank of biotech innovation, China has issued the National Program on Bioscience Technology Development 2010-2020. The program, which was issued by the Ministry of Science and Technology, establishes a series of ambitious, very specific goals for developing a world-class biotech industry in China. As a starter, China wants to produce three to five top biotech scientists with international reputations and Nobel Prize potential by 2020. More details....

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China Supports Foreign Direct Investment in Biotechnology Dec 30, 2011: China issued new rules that will encourage foreigners to invest in China biotechnology companies. Because biotechnology is a favored industry, foreign direct investments in the sector will be subject to a lower level of administrative scrutiny and may also qualify for preferential tax treatment and other benefits. More details....

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China Will Regulate TCM Products to Improve Their Purity Dec 13, 2011: China’s State Council has ordered measures that will more tightly regulate the production of TCM products. The goal is to increase the safety of TCM drugs and also improve their efficacy. The new rules will affect both how TCM raw materials are grown and how companies extract their active ingredients for botanical sources. More details....

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China's 12th Five-year Plan for Medical Technology Dec 2, 2011: China has released its 12th Five-year Plan for Medical Technology, setting a long list of broad goals to be accomplished by the end of 2015. Those goals range from discovering world-leading medical technology to establishing robust means of diagnosing and treating China’s rural population, who live far from the country’s high-tech hospitals in urban centers. This Plan does not mention how much financial support each of the goals will receive, but it does lay out the country’s agenda for 2011-15. More details....

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WHO Certification a Shot-in-the-Arm for China Vaccine Makers Dec 1, 2011: On March 1, 2011, the World Health Organization certified that the SFDA’s standards meet international criteria for vaccine supervision. Other regulatory hurdles remain, but the WHO imprimatur means China vaccine makers will eventually be able to supply vaccines to resource-poor nations through UN-related agencies, a huge market. Over time, the WHO action could transform China’s vaccine industry. More details....

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PRC Increases Goals of Healthcare Reform Dec 1, 2011: China wants to increase the benefits of healthcare reform. To accomplish that, the PRC will seek to implement measures that increase the per-person allowance in medical insurance plans and extend the essential medicine system to public clinics in villages and private clinics. The initiative was announced by the PRC’s Vice Premier, Keqiang Li, in a meeting convened by the State Council that was devoted to health care. More details....

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China Plans $1.7 Trillion Investment in Hi-Tech, including Biotechnology Nov 21, 2011: China will invest 10 trillion RMB ($1.7 trillion) over the next five years into five strategic industries – one of which is biotechnology. The program and the amount were announced by US Commerce Secretary John Bryson, who is visiting China on an official trade mission. The program was reported for the first time one year ago in a Reuters report, but it was never officially confirmed. More details....

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SFDA Will Inspect Foreign Drug Makers Nov 17, 2011: The SFDA has announced it will begin inspecting foreign drug makers whose products are imported into China. The initial batch, mainly volunteers, will consist of five to ten foreign drug makers from five different countries. These companies signed up because they want to help the SFDA refine its inspection skills. The move reflects China’s desire to bring its drug regulation system up to international standards. More details....

The FDA Improves Tracking of Foreign-Sourced Drugs Nov 2, 2011: The US FDA is instituting a new IT system that tracks the source of drugs to help control the risks of drugs manufactured in foreign countries. For countries like China, the new system asks companies to increase their cooperation with the US pharmaceutical regulator. Drug companies whose products are well documented will be rewarded with expedited customs clearance. More details....