Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group... 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
India’s growing medical device market has prompted many multinational companies to open their own local offices in the country. In 2007 alone, over 25 foreign medical device companies such as Boston Scientific, Medtronic, Abbott, DePuy and others received product import clearances for... Read More
After joining the WTO in January 2007, Vietnam has seen a sharp increase in foreign investment in its pharmaceutical industry. In 2007 alone, there were 58 new foreign businesses in this industry. Vietnam’s Ministry of Health reported that by the end of... Read More
Thailand’s Food and Drug Administration (FDA) is planning to increase fines on importers, sellers, and manufacturers of fake drugs. Currently, the FDA is proposing to amend Drug Act of B.E. 2510 where manufacturers can be fined up to 5 million baht (about... 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
The People's Republic of China has become the foremost manufacturing center in the world today. Chinese manufacturing output increased from 4% of the global total in 1995 to 10% in 2006. Over the past 15 years, gross domestic product has grown at... Read More
The Taiwanese legislature passed the “Biotech and New Pharmaceutical Development Act” in June 2007. The Act is designed to offer incentives to companies in the pharmaceutical and biotech industry. In one major change, the Act allows publicly-funded researchers to help private companies... Read More