Japan to extend PMS data requirements

Starting October 2001, Japanese drugmakers must collect and submit dataconcerning the side effects of new medicines for up to six months following launch, the Ministry of Health and Welfare has announced.

Manufacturers will have to send representatives into physicians' offices regularly in order to determine whether there are any significant side effects or other safety issues relating to new products, reports Kyodo News International.

The MHW has also revised a post-marketing surveillance regulation extending for six years following a new product's launch. Currently, manufacturers must conduct research on 3,000 people without specifying any make-up of the study population. However, the revision requires them to concentrate on children, the elderly or patients with kidney or liver problems who may not have been included in clinical studies.