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www.fdanews.com/articles/84641-japanese-unsure-on-generics-informed-on-side-effects

JAPANESE UNSURE ON GENERICS, INFORMED ON SIDE EFFECTS

February 17, 2006

A new survey conducted by a Japanese generics manufacturer claims 90.6 percent of consumers are willing to use generics, but only 2.6 percent have tried to get them prescribed due to apprehension over the products. Meanwhile, the country's main drug regulator, the Pharmaceutical and Medical Devices Agency (PMDA), has started to release more comprehensive information on the drug side-effect notifications filed by manufacturers.

The 416-subject internet questionnaire also showed that the proportion of all respondents actually receiving generics fell to 1 percent. The main reasons were that people did not know how (40.7 percent) or when (32.3 percent) to ask, or "felt uncomfortable" about inquiring (31.4 percent).

Japan's generics sector accounts for just 5 percent of the total drug market by value, but sales could grow 50% per year to US$3bn over the next 5 years.

The PDMA has posted on its website details of drug side-effects submitted by companies as of April 2004, when the agency was established. During the month, there were 2,477 reported side-effects involving 732 drugs, including 63 deaths. A total of 12 of these fatalities were linked to a new cancer therapy.

Japan's Ministry of Health, Labour and Welfare had been releasing monthly bulletins on serious adverse drug reactions resulting in changes to prescribing precautions for some time. However, the release of broader data by the PMDA suggests that these covered only a minor portion of all adverse events.