Japan's Drug Approval System To Be Reformed

Rumors that the Pharmaceutical Affairs Bureau of Japan's Ministry of Health and Welfare will be abolished have proved to be true (Marketletter September 2).

According to various media reports, quoting Ministry sources and verified by the Marketletter, this will be part of a revamping of the process for evaluating and registering new drugs in Japan, bringing the country's system more into line with that of the USA's Food and Drug Administration. The present eight sections of the PAB will be reduced to six under the (tentative) name of Drug Safety Bureau; the Research and Development section will be abolished and the Policy and Economic sections will be combined.

The PAB has long had the dual function of acting as the overseer of drug safety on the one hand and promoting the pharmaceutical industry on the other, roles that have been criticized as contradictory. The criticism has intensified over the past year as a result of the spread of HIV among hemophiliacs and others due to the use of unheated blood coagulants contaminated with the virus in the 1980s.