In August 2007, China’s State Food and Drug Administration (SFDA) issued six Working Procedures, laying out how it would conduct various procedural requests about medical device product registrations. The most notable of these was a detailed description of how to apply for... Read More
China’s State Food and Drug Administration (SFDA) has recently issued various laws to regulate more stringently quality control in the medical market. The US Department of Health and Human Services (HHS) is also helping China improve its medical market. The HHS and... Read More
The Chinese State Food and Drug Administration (SFDA) has recently issued a draft regulation “Measures on Managing Registration of Drugs,” which is currently soliciting public opinions on it. These measures outline new guidelines for evaluating drugs before marketing them in China. The... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a post-marketing system to harmonize medical device adverse event reporting. AHWP members have varied systems for adverse event reporting, and some have no system at all. The new draft document aims at reducing... Read More
With persistent issues of corruption and counterfeiting, China has implemented various policies to address its troubled pharmaceutical industry. From the antibiotic Xinfu scare, which led to at least 10 deaths to a bribery investigation of the former head of the State Food... Read More
With steadily increasing drug development costs and significant time spent on clinical trials, outsourcing clinical trials in Asia has rapidly become an appealing option for many firms. As developing a single drug can cost more than $200 million and take at least... Read More
INTRODUCTION China is the fastest growing economy in the world today. In 2004, GDP in China grew by 9.0%, while in 2005 it grew by 9.8%. Analysts predict that China’s economy will continue to grow at 8% to 9% per annum through... Read More
The World Health Organization (WHO) and various international partners came together in Germany November 2006 to develop a task force focused on preventing the global spread of counterfeit medicines. The International Medical Products Anti-Counterfeiting Taskforce, or IMPACT would cover legal, technological, communications... Read More
China's economy is growing rapidly, and so are standards of production. As its manufacturers continue to develop more sophisticated processes and products, quality standards are increasing dramatically. Medical devices are no exception. China's medical device market has grown to $6 billion, the... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More