Ministry of Health, Labour and Welfare


Pharmaceutical and Medical Safety Bureau

In Pursuit of Safety of Drug and Medical Care

The bureau implements measures for securing the efficacy and safety of drugs/quasi-drugs, cosmetics and medical devices, safety measures for medical institutions, and measures against narcotics and stimulants, while handling blood business. Thus, the bureau addresses various issues directly related with people's life and health.

Takes Charge of People's Life and Health

The advancement of pharmaceuticals and medical devices had resulted in the marked improvement of health and sanitary conditions of the nationals. A lot of even more efficacious products have been developed as a result of the rapid development of frontier technologies in the last few years. On the other hand, products that are difficult to take or that could cause severe adverse reactions have also increased. Under such circumstances, people's interests in the safety of pharmaceuticals have grown to the greatest ever.
In light of the above, the Pharmaceutical and Medical Safety Bureau strives to protect people's life and health through comprehensive efforts, covering clinical experiments, technical examinations for registration and after-sales follow-ups, to secure the safety, efficacy, etc. of pharmaceuticals.

Promptly Provides Efficacious Drugs

As for clinical examinations, or the last stage of the development of pharmaceuticals, "Standards on the Implementation of Clinical Trials on Drugs (New GCO)" was fully enacted in April 1998 aiming to satisfy scientific and ethical requirements. In the meantime, efforts for smooth implementation of clinical examinations are also being promoted, including the establishment of a system to invite positive participation of subjects in clinical examination and the improvement of a system of medical institutions conducting clinical examinations. This is to activate clinical examinations in Japan that have reportedly become stagnant.
As for the system for technical examinations for registration, "Drug and Medical Device Examination Center" specializing in such examinations was set up in July 1997. The number of examiners is to be doubled under a three-year program, as part of efforts for radically strengthening the system. The center gives and promptly completes examinations that can stand comparison with those in Western nations.
In addition, efforts for securing international harmonization among regulations on pharmaceuticals are being promoted aiming to provide excellent drugs promptly to nationals, through, for example, "International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use among Japan, the US and the EU".

Pursues Safety of Pharmaceuticals

It is necessary to collect information upon adverse reactions of drugs widely both at home and abroad, appropriately evaluate such information, promptly take measures against them, and offer such information widely to medical professionals, etc. A system coordinating various countermeasures is to be established to that end, while "Drug Information Offering System" using the Internet was put into operation in May 1999.
At the same time, "separation of dispensing and prescribing drugs" is being promoted to avoid duplicate dispensing as a result of receiving medical care at different departments and to eliminate mutual reactions among different drugs, while allowing pharmacists to give sufficient drug administration guidance.

Pursues Safety in Medical Services

The bureau promotes measures for securing safety in medical services, implementing, for example, various measures against hospital infection including the preparation of a guideline, so that people can receive medical services without anxieties.

Provides Safe Blood Products through Blood Donation by Nationals

Blood transfusion products produced from donated blood and various plasma derivatives are precious pharmaceuticals that are essential for medical treatment. Accordingly, the bureau implements various measures for promoting blood donation, effective utilization of donated blood, appropriate uses of blood products at medical institutions, the introduction of state-of-the-art scientific technology, etc. Thus, the bureau strives to secure domestic self-sufficiency and safety in blood products.

Aims to Create a Society without Drug Abuses

In the last few years, drug abuses, mainly stimulant abuses, have increased significantly in Japan, particularly among juveniles, causing serious problems. To face with such circumstances, the ministry promotes a variety of measures as the ministry for comprehensive promotion of drug abuse eradication measures under the "Five-Year Strategy to Prevent Drug Abuses" mapped out in May 1998. Such measures include the tightening of regulations, the upgrading of public education, the promotion of measures to prevent repeated abuses and the promotion of international cooperation.