On December 17, 2009, China, Japan, and Korea participated in the second WG meeting on drug clinical trials. This meeting included China’s SFDA, Korea’s Food and Drug Administration (KFDA), and Japan’s Ministry of Health Labor and Welfare (MHLW) and Pharmaceuticals and Medical... Read More
China’s State Food and Drug Administration (SFDA) issued new plans for ensuring the quality of essential drugs on November 25, 2009. All provincial food and drug administrations will need to focus on strengthening essential drug production and quality control supervision work. They... Read More
China's State Food and Drug Administration (SFDA) continues to ramp up plans to improve quality and increase regulations in the medical device arena. After setting up a trial Good Manufacturing Practice (GMP) scheme for sterile and implantable medical devices, SFDA issued the... Read More
More and more medical device companies are sourcing and manufacturing their products in China. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about QA in China to be... Read More
On September 11, 2009, China’s State Food and Drug Administration (SFDA) hosted a Medical Devices Task Force meeting in China. The agenda covered various medical device topics and regulations. For clinical trials, the US encouraged China to adopt a risk based approach... Read More
In today's global recession, innovation, creativity and resourcefulness are essential. Using these tools to determine the appropriate regulatory strategy for your medical device could decide the success or failure of your product in Asia. This article provides the most recent regulatory updates... Read More
As part of China’s overhaul of its healthcare system, the government has recently released a list of approximately three hundred medicines that are expected to be sold at government-controlled prices starting in September. The list of essential medicines includes Western medicines such... Read More
In the most recent development of China’s nationwide health care reform that was introduced in January of this year, the Chinese Ministry of Finance stated on July 6, 2009 that approximately 10.4 billion RMB (approximately $1.52 billion) would be allocated to public... Read More
As the global economic crisis deepens, China is entering a new phase in its development. Its exports, economic growth, and employment levels are all falling. It is, however, important for Western businesses to keep these changes in perspective. China's gross domestic product... Read More
R&D in Asia has the potential to significantly improve the global performance of medical device companies by cutting costs and speeding product development--but extensive due diligence is required for success. Read More