Japan's PMDA to publish all adverse effects

On January 31, Japan's Pharmaceuticals and Medical Devices Agency started to publish all drug adverse effects which are obligatorily reported by pharmaceutical manufacturers. At first, all of the AEs that had been reported during April 2004 were announced on the PMDA's web site the same day. Other adverse effects after May 2004 will be published sequentially.

Until now, only the cases of AEs in which the causal relationship between the adverse events and drugs is strongly suspected have been announced on the web site. In addition, the PMDA began to publish a pharmaceutical guidance for patients that is compiled by drug manufacturers from the same date.

The guidance is designed to increase awareness of drug compliance and adverse events and is checked by the Ministryof Health Labor and Welfare and the PMDA. An oral anti-diabetic drug guidance for patients as the first guidance was placed on the web site the same day.