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
The Korean Ministry of Health and Welfare has announced that it will implement price cuts on drugs produced by foreign pharmaceutical companies. In addition to cutting drug prices, the government also cut the number of drugs that are covered by insurance, only... 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
The Korea Food and Drug Administration (KFDA) recently approved the first multinational clinical trial for a medical device. The device, the Nobori drug-eluting stent, is manufactured by the Terumo Corporation, an international medical device company headquartered in Tokyo, Japan. The trial involves... Read More
New IVD regulations are being developed throughout Asia. In Korea, before IVDs are permitted to enter the Korean medical market, these products require approval by the Korean Food and Drug Administration through a process similar to the pre-market approval (PMA) process for... Read More
The Korea Food and Drug Administration (KFDA) has continued its efforts on harmonization of medical device standards with the enactment of medical device Good Clinical Practice (GCP) regulations on July 14, 2005. Previously, GCP regulations were not established for medical devices in... Read More
In May 2005, a Memorandum of Understanding was signed by members of the World Health Organization (WHO), Korea Ministry of Health and Welfare (MOHW) and Korea Food and Drug Administration (KFDA), as a means of cooperating on chemical safety activities. Under the... Read More
The National Health Insurance (NHI) Act oversees all public health insurance in Korea. This Act covers the entire population and all citizens earning an income in Korea must contribute a percentage of their monthly salary. Today, the Korean government considers the medical... Read More
Korea’s Ministry of Health and Welfare (MOHW) recently announced plans to deregulate a number of medical laws in hopes of boosting the country’s medical sector. The new bill, to be drafted by the end of 2005 and passed early in 2006, is... Read More
In Korea, the National Health Insurance (NHI) Act oversees all public health insurance. This Act covers the entire population and all citizens earning an income in Korea must contribute a percentage of their monthly salary. The Ministry of Health and Welfare (MOHW)... Read More