Since 1985, Japan’s In Country Caretaker (ICC) system has allowed foreign medical manufacturers without a local office in Japan to register products “directly” in their own name (Japan law does not allow medical companies without a local presence to register their products... Read More
Scientists in Singapore will be allowed to withdraw stem cells from adult human tissues, aborted fetuses, and surplus embryos less than 14 years old for research purposes, according to new guidelines approved by the Central Government July 17, 2002. The cloning of... Read More
A recent report by the accounting firm, Ernst & Young, finds an increase in the amount of investment by governments in the Asia-Pacific region in biotechnology. Besides investment incentives and tax breaks, governments have begun to nurture the fledgling industry with increased... Read More
With the world’s largest population and an immense pool of untreated patients, many who qualify for various clinical testing, China poses an attractive prospect for pharmaceutical companies. US drug manufacturers are realizing the untapped potential of testing in China. Most importantly, costs... Read More
India is the world’s second most populous country after China, with a total population of about 1 billion. While much of India is rural and poor (over 70 percent of the population lives in rural areas and the per capita income is... Read More
The Drug Control Authority (DCA) is the regulatory agency charged with regulating pharmaceutical products in Malaysia. Established under the Control of Drugs and Cosmetic Regulation 1984 (CDCR), the DCA’s main task is to ensure the quality, safety, and efficacy of pharmaceutical and... Read More
For new medical devices and pharmaceuticals for which there are no equivalent products already approved in Japan, clinical trials are required. This rule also applies to previously approved products to which improvements or modifications are made which could potentially improve the efficacy... Read More
As part of a larger reorganization and reform effort, in January 2001 Japan’s Ministry of Health and Welfare and Ministry of Labor merged, creating the Ministry of Health, Labor, and Welfare (MHLW). Among other things, the agency’s mandate includes the promotion of... Read More
In line with its accession to the World Trade Organization (WTO), the Chinese government promulgated a new Drug Administrative Law effective December 2001. New clauses address drug quality control, labeling and advertising restrictions, and other issues related to safety and improving standards... Read More
Japan’s Ministry of Health, Labour, and Welfare (MHLW) announced its latest wave of drug pricing cuts last month, the latest in a series of biennial price adjustments that began in the early 1990s. Under the Japanese national healthcare insurance system, the government... Read More