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
The Bureau of National Health Insurance (BNHI) of Taiwan recently issued its fifth round of drug price cuts, to take effect from November 1, 2006. This cut represented a compromise from earlier plans. The initial proposal put forward by the government was... Read More
While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety... Read More
Taiwan’s Bureau of Pharmaceutical Affairs, a section of the Department of Health, is working on plans to raise clinical trial review fees for New Chemical Entities (NCEs) from the current level of about $1,500 to about $18,300, or somewhere in between. No... Read More
Asia has a population of over 4 billion people, and represents about 60% of the world's population. Annual economic growth rates in the Asian countries have been as high as 8 or 10% over the past decade, in comparison with some developed... Read More
To expand their sales in the Asian medical markets, medical companies need to stay abreast of the new and changing regulatory environments for drugs, devices and In Vitro Diagnostics (IVDs). New or improved regulations are implemented frequently in Asia, including changes in... Read More
Taiwan's National Health Insurance (NHI) Program was established in 1995 in order to provide affordable, good quality health coverage to all citizens. Previously, three different insurance systems were in effect, offering nearly a dozen different insurance programs. These programs were only available... Read More
Taiwan's medical device market is one of the most advanced in Asia and it continues to be increasingly sophisticated. The market is worth nearly $900 million, making it Asia's 4th largest. Taiwan's domestic industry is growing, but it remains largely fragmented and... Read More
In response to pressure from the U.S. government, Taiwan recently decided to take measures to regulate and protect the data of pharmaceutical companies. On September 22, 2004, Taiwan’s government approved draft amendments to their Pharmaceutical Affairs Law. Under these new amendments, foreign... Read More
In order to attract more foreign companies to collaborate with domestic companies and develop advanced technologies in Taiwan, the Taiwanese government has launched several programs to lure foreign investors into the country’s biotechnology sector. Additionally, the Taiwanese government also hopes to expand... Read More