Singapore, a tiny city-state with a population of only 4 million, has one of the world’s strongest economies, with GDP per capita of US$28,000, similar to that of the United States. Singapore spends approximately US$2.5 billion per year on healthcare, for an... Read More
Despite Hong Kong’s reversion to China in 1997, under the terms of its return, Hong Kong is exempt from the rules and regulations outlined above for Chinese medical devices. Hong Kong does require general registration of imported medical devices, but there are... Read More
In India, the major sources for pharmaceutical regulation are the Drugs and Cosmetics Act of 1940 (DCA) and the Drugs and Cosmetics Rules (DCR). This legislation applies to the whole of India and all products, whether imported or made in India. The... Read More
China’s $22.5 billion pharmaceutical market is the second largest in Asia, after Japan, and foreign drug imports and pharmaceutical investment in China will likely increase as China enters the WTO. Anticipating an influx of foreign pharmaceuticals, the Chinese government established the State... Read More
The Vietnamese government has announced it will invest up to $1.5 billion in the pharmaceutical manufacturing sector over the next 10 years. The money will be used for a variety of programs, including upgrading technology to meet Good Manufacturing Practice standards, developing... Read More
Given Japan’s conservative regulatory environment, it should come at no surprise that advertising and promotion of medical devices and pharmaceuticals in Japan is highly regulated and very restrictive. Without shonin, or “approval” of a product, advertising the name, manufacturing process, indications, effects,... Read More
Though most medicine manufactured by foreign joint ventures, large State-owned enterprises, or foreign manufacturers (including imports) is labeled correctly, much of what is manufactured by small domestic producers is not. Product information and labels on locally manufactured products often omits potentially negative... Read More
Once severely restrictive in practice and economically limited, markets in China are beginning to hold brighter prospects for successful entry by foreign manufacturers and suppliers. Medical product companies looking for product import, distribution and manufacturing opportunities in China will find promise in... Read More
Despite the damage from the Asian financial crisis, South Korea’s economy is moving ahead with a surge in imports and increased consumer confidence. The Korean pharmaceutical market is no exception to Korea’s economic boom. The Korean Ministry of Health and Welfare (MHW)... Read More
Clinical trials are essential in monitoring the safety and quality of all pharmaceuticals. Japan's Ministry of Health and Welfare (MHW) and the drug organization (KIKO) are working with the Pharmaceutical and Medical Device Evaluation Center in Japan to guarantee that safety standards,... Read More