Pharmaceutical Administration Regulation & Drug Development in Japan

The development of new medicines is a serious issue in Japan. There are an estimated 40,000 medical products on the market in Japan, all of them regulated by the Ministry of Health, Labor and Welfare and its constituent councils and bureaus.

Regulatory Bodies

• The Ministry of Health, Labor and Welfare and the Pharmaceutical Affairs and Food Sanitation Council are in charge of pharmaceutical administration and drug development in Japan. According to the Japanese government's "Information in English on Japan Regulatory Affairs," the Pharmaceutical and Food Safety Bureau "handles clinical studies, approval reviews and post-marketing safety measures," including licensing.

Principal Regulatory Laws

• For the most part, pharmaceutical administration and drug development in Japan is controlled by a number of laws. These include the Pharmaceutical Affairs Law, the Pharmacists Law, Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization, Law Concerning Securing a Stable Supply of Blood Products, Poisonous and Deleterious Substances Control Law, Narcotics and Psychotropics Control Law, Cannabis Control Law, Opium Law and Stimulants Control Law.

Approval of New Medicine

• Drug manufacturers must submit a wide range of documentation to the Ministry of Health, Labor and Welfare, and decisions about approval may take between six to 18 months. Approved medicine must also be covered by the national insurance system, and so must conform to the drug pricing standards. This increases the price of the drug.