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
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
In April 2004, Taiwan’s Department of Health (DOH) published a new draft that will alter the classification and registration system for medical devices in Taiwan. The regulation will be formally announced in late 2004, once the DOH receives feedback from the medical... Read More
After conducting several recent investigations into medicine labeling habits of pharmacies in Taiwan, the Taiwan Department of Health (DOH) found that some pharmacies are failing to comply with the labeling requirements. Currently, several associations in Taiwan are establishing programs to provide additional... Read More
Many regulatory authorities in Asian countries are choosing to allow medical device product registration submissions to be done in electronic form. Previously, all governments required product registration applications to be completed in paper form, however, technical advances and the advent of a... Read More