There is no doubt that China is and will continue to be a global hotspot for the medical industry. Yet many Western companies that rush haphazardly into China without fully understanding its business culture and mentality ultimately meet with failure. This presentation... Read More
China’s Center for Drug Evaluation (CDE) under the State Food and Drug Administration (SFDA) has recently released statistics for CDE drug registration approval recommendations in 2008. The CDE reviewed over 25,000 applications, including those for clinical trials, import, and production, but rejected... Read More
On January 21, China’s State Council approved the implementation of China’s long-awaited healthcare reform plan. All levels of government will be investing a total of RMB 850 billion (approximately US $124 billion) over the next three years to implement the changes in... Read More
In November 2008, the Chinese Diabetes Society (CDS) released the results of its study into the epidemiology of diabetes in China. The results suggested that diabetes is becoming prevalent in China more rapidly than previously estimated, increasing the market prospects for Western... Read More
On October 28, 2008, China’s State Food and Drug Administration (SFDA) announced the implementation of a “catalog management” system for a list of specified medical devices and drugs. This is part of a Chinese effort to extend regulation to exported medical products... Read More
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
On September 16, 2008, high-ranking officials from both China and the U.S. met in California to discuss important issues, such as medical product importation regulations and intellectual property rights. The 19th U.S. – China Joint Commission on Commerce and Trade (JCCT) included... Read More
In September 2008, China’s State Food and Drug Administration (SFDA) issued a notice that continues standardization of the registration process for imported medical devices. Several previous notices were abolished and thus no longer apply. Medical device companies applying for product registration should... Read More
On September 1, 2008, China’s State Council approved the Ministry of Health’s (MOH) plans for reorganization. In line with the State Council’s earlier announcement in March 2008 that the currently independent State Food and Drug Administration (SFDA) would fall under the management... Read More
The SFDA, with the aid of pharmaceutical industry associations, is pushing hard to stop the illegal manufacture of active pharmaceutical ingredients (API) and intermediates in China. The SFDA announced its plans in June to set up an API supervision network, accessible through... Read More