In November 2002, China’s State Drug Administration (SDA), which has been replaced by China’s new Food and Drug Administration, issued an official memorandum announcing new regulations related to diagnostic products. The memorandum indicated the following basic guidelines: Both the drug and medical... Read More
The Chinese government’s efforts to control the skyrocketing prices of pharmaceuticals in China are threatening the profit margins of foreign pharmaceutical manufacturers. The government’s measures to control drug prices has been two fold, the first is the implementation of a competitive bidding... 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
Heart disease continues to be one of the leading causes of death in Asia. As countries like Japan, China, Taiwan and the Philippines have a greater demand for medical devices and pharmaceuticals to help treat cardiovascular disease, many foreign medical companies have... Read More
In a move to raise competitiveness in the pharmaceutical industry in China, the State Food and Drug Administration (SFDA), the government body which has replaced the State Drug Administration for some pharmaceutical regulatory functions in China, has lifted price controls on over... Read More
In response to the recent price fluctuations of medical products in China due to the SARS (Severe Acute Respiratory Syndrome) outbreak, the Chinese government released a circular in April 2003 announcing that measures will be taken to prevent price gouging on medical... Read More
Despite the slowing economies, Asia still continues to offer medical device manufacturers many investment opportunities. With information and updates on China, Malaysia, Thailand, the Philippines and ASEAN, this article highlights the benefits and advantages of manufacturing medical devices in Asia. Asian countries... Read More
The Chinese government announced on March 6, 2003 a radical restructuring of several government bureaucracies. Among the government bodies that will undergo drastic change will be the Ministry of Health, Ministry of Commerce, and Ministry of Foreign Trade and Economic Cooperation. The... Read More
As Asian countries begin to adopt more western lifestyles and foods, “western” diseases are becoming more prevalent killers in Asia. Economic transition, urbanization, and technological development have brought about lifestyle changes that have increased the chances for heart disease in Asia. Developing... Read More
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to... Read More