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
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
On the surface, Japanese GCP guidelines seem fairly standard and straightforward. Basic duties and requirements for the medical institution(s) at which trials are held, the physicians involved, the Institutional Review Board, and the Trial’s Sponsor are very similar, if not identical, to... Read More
Foreign companies looking to penetrate medical device markets in Asia need to pay close attention to the regulatory environment in order to handle the difficulties that await them. Japan's medical device market is the second largest market in the world, worth almost... Read More
Effective January 14th, Japan’s Ministry of Health, Labour, and Welfare (MHLW) issued new guidelines for medical device packaging. The Guideline of Package Insert for Medical Devices aims to provide physicians and consumers with clearer, more comprehensive product and usage information to prevent... Read More
The Japanese Ministry of Health, Labor and Welfare (MHLW) recently passed a new foreign reference pricing policy for medical equipment that will take effect on April 1, 2002. The decision has sparked controversy, as many U.S. observers believe the new policy violates... Read More
Mergers and acquisitions in the Japanese healthcare industry are on the rise. The strength of the dollar (versus the yen) and deregulation in Japan have many U.S. and European drug companies planning to increase their presence in Japan, where pharmaceutical sales are... Read More
Compared to the U.S. and many European countries, the biotechnology industry in Asia is embryonic. However, in recent years, several Asian countries have designated the expansion of biotechnology as crucial to their economic development. Some governments in Asia have thus begun taking... Read More
The Asian market as whole is huge, comprising some 3.5 billion people -- 60% of the world total. Each country, though, has its own culture, business norms, and regulations, and companies investing in the region need to be aware of the differences.... Read More