The Asian Harmonization Working Party (AHWP) met in March 2008 in Malaysia. In addition to discussing updates of the AHWP Technical Committee (TC), members also discussed updates on the Global Harmonization Task Force (GHTF) during the 4th APEC funded seminar. The six... Read More
The East Asian Pharmaceutical Regulatory Symposium was recently held April 14-15 2008 in Tokyo. At the Symposium, the Health Ministers of China, Japan and Korea agreed to promote increased clinical data sharing and encourage global drug development. The three Ministers affirmed the... Read More
With increasing out-of-pocket expenses and little to no support from the government, many people in China choose to not receive any medical care. Based on a national health survey taken in 2003, nearly 50 percent of people who should seek medical care... Read More
Introduction For pharmaceutical companies in China, today is a very exciting time, but also a highly challenging one. Thanks to a rapidly rising economy (GDP growing over 11% in 2006) and newly prosperous citizens wanting better healthcare, the pharmaceutical market there is... Read More
China’s State Food and Drug Administration (SFDA) has decided to select medical device experts to enforce its “Regulations for Supervision and Administration of Medical Devices” and “Provisions for Medical Device Registration.” These experts will help standardize the technical examination of medical devices... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
With growing concerns of quality control in China, the U.S. will soon have access to records of Chinese manufacturers failing to comply with regulations. China’s State Food and Drug Administration (SFDA) and the US Department of Health and Human Services (HHS) issued... Read More
The State Food and Drug Administration (SFDA) of China has blacklisted 13 companies manufacturing unapproved medical devices. SFDA ran a spot check of 17 provinces, including Beijing, Shanghai, Guangdong, and others. The unapproved medical devices included single-use transfusion machines, metal bone and... Read More
Asia's growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India's GDP figures progressed from 7% to 9% over the same period. These countries' medical device markets are... Read More
China ‘s State Food and Drug Administration (SFDA) plans to set up a system recording companies’ advertising drugs, medical devices, and health foods, to better monitor and assess individual company performance. The new regulations will take effect on January 1, 2008. In... Read More