The Japanese government recently approved a plan to amend the ban on “mixed medical care” in Japan. Mixed medical care refers to the use of both insured and uninsured medical treatments by medical institutions and doctors. The mixed medical care ban requires... Read More
Japan’s New Pharmaceutical Affairs Law (PAL) will include revisions to the Good Manufacturing Practice (GMP) regulations for medical devices. Under the New PAL beginning April 2005, all medical devices manufacturers will need to meet the new Japanese GMP regulations, based on ISO... Read More
As the official implementation date of the new PAL approaches (April 2005), Japan’s MHLW continues to make announcements of new Japanese medical device regulations. One of the most significant changes affecting both foreign and domestic companies selling medical devices in Japan will... Read More
Japan’s Ministry of Health, Labor and Welfare (MHLW) recently published in English, a draft regulation on the requirements for marketing authorization approval for in vitro diagnostics (IVD). The MHLW will evaluate the purpose of use, principle, structure, shape, category specifications, usage, etc.... Read More
Japan’s new Pharmaceutical Affairs Law (PAL) will be fully implemented in April 2005. Included in the changes will be the new requirement that all low-risk medical devices, or controlled medical devices, be evaluated by a third party organization. Japan’s Ministry of Health, Labor... Read More
Japan ’s Ministry of Health, Labor and Welfare (MHLW) recently issued a regulation to standardize the names of generic drugs. In the past, some generic drugs were given similar names, often causing confusion and even dispensing errors by pharmacists, doctors and hospitals.... Read More
Recently, Japan has seen a surge in hospital errors as well as an increase in improper administration of anticancer medications, prompting Japanese health officials to take action against these negative trends. Two new programs have been established by the Japanese Ministry of... Read More
Three major agencies responsible for drug and medical device approval in Japan merged into one organization called the Pharmaceuticals and Medical Devices Agency (PMDA), on April 1, 2004. Previously, the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), Organization of Pharmaceutical Safety and... Read More
In the past, visits to Japan’s Ministry of Health, Labor and Welfare (MHLW) for advice were free and non-binding. At these sessions, the MHLW officials usually would not make any comments, or if any comments were made, they normally did not carry... Read More
The race is on among foreign pharmaceutical manufacturers to meet the needs of Japan’s increasingly aging female population. Demand for treatments for osteoporosis, breast cancer, and other post-menopausal ailments is expected to grow in line with the rising number of women suffering... Read More