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Health ministry prepares guidelines for prescription of new drugs

  • August 24, 2016
  • , Yomiuri , p. 35
  • Translation

In response to the recent rise in new, expensive medications entering the market, the Ministry of Health, Labor and Welfare announced a policy to assign more personnel to the Pharmaceutical and Medical Devices Agency under the ministry and issue guidelines to ensure the appropriate usage of new medications.


For each new medication, the guidelines, called “guidelines to promote optimal usage,” provide profiles of the kind of patient that is expected to benefit most from the new medication based on genetic characteristics, as well as the minimum requirements necessary for physicians and hospitals to be able to prescribe the new medication.


The agency will analyze data from clinical trials and issue guidelines prior to each medication’s market launch. Post-launch data will be studied to make changes to the guidelines if necessary.


Behind the ministry’s move is the concern that an increasing number of highly priced medications, especially for cancer patients, will further strain the country’s healthcare system. (Abridged)

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