In Japan, it is still common for medical doctors to limit the amount of information they give to their patients. Doctors in Japan are seen as “kings,” similar to the situation in the U.S. in the 1950s and 1960s prior to managed... Read More
The Japanese Health Insurance Reform Bill was enacted at the end of July 2002. This reform will shift healthcare cost burdens towards the active workers and the elderly. The main changes as a result of the bill are as follows: Co-payment for... Read More
In an effort to strengthen Japan’s drug development capabilities, a group of about 20 public, academic, and private organizations are together forming the Kansai Bio-Information Highway Project. The project comprises of an extensive computer-networking endeavor that will allow participants of the project... Read More
Slowing economies have not stopped Asian countries from moving ahead with medical device regulatory reforms. Asian consumers demand high-quality healthcare products, making it worthwhile for American manufactures to be active in the region. Procedures and practices vary according to country. This article... Read More
The Japanese House of Representatives passed and enacted the revised Pharmaceutical Affairs Law on July 25, 2002. The revision of the law will facilitate start-up pharmaceutical and medical device companies that do not have production facilities in Japan to enter into the... Read More
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
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