A Ministry of Health, Labor and Welfare (MHLW) panel has recommended reclassifying 350 drugs and allowing them to be sold as over the counter (OTC) medications at convenience stores. Types of drugs include intestinal remedies, gargles, antiseptics, vitamin-based remedies and cough rubs.... Read More
Japan’s Ministry of Health, Labor, and Welfare plans to implement a new rule requiring prescription drugs to have bar codes in order to reduce dosage errors. The first phase is planned for the summer of 2005. Later this year, a panel of... Read More
The Japanese Ministry of Health, Labor and Welfare recently announced in October 2003, their plan for a notification system for minor changes in approved medical products. The guidelines for the notification system will be included as part of the revised Pharmaceutical Affairs... Read More
Japan's complex medical marketplace has been significantly deregulated in the past several years. The government has also taken some measures to be more open to foreign businesses, thus allowing more foreign companies to enter Japan's medical market. Several business and regulatory strategies... Read More
The higher costs associated with conducting clinical trials in Japan is forcing many of Japan’s top pharmaceutical manufacturers to perform their clinical studies in other countries. This has resulted in the reduction of the number of clinical trials performed in Japan. Contract... Read More
One of the main purposes of the recent revisions in Japan’s Pharmaceutical Affairs Law (PAL), which was passed into legislation in 2002, was to place a greater burden of responsibility for companies to assure quality. The Ministry of Health, Labor and Welfare... Read More
Japanese drug makers are looking into the future and investing in drug development based on the human genome. Major Japanese pharmaceutical manufacturers are now looking for links between drugs and genetics since the effective completion of the human genome map. Drug makers... Read More
The Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science, and Technology (MECSST) in Japan jointly unveiled their “Three-Year National Drug Clinical Trial Action Plan” on April 30, 2003. The plan, which will run from 2003... Read More
As part of the extensive Pharmaceutical Affairs Law (PAL) revisions in Japan, the Japanese government has instituted changes to their current regulations in order to consolidate safety measures for biological products. The regulatory changes for biological products were introduced in July 2003.... Read More
In early April 2003, the Japanese government took its first steps towards granting patents to medical procedures. A council for the Ministry of Economy, Trade and Industry drafted a plan that would allow patents to be granted for medical techniques associated with... Read More