Draft for speeding Japan drug provision

The Study Group on Rapid Supply of Effective and Safe Drugs within the Japanese Ministry of Health, Labor and Welfare has discussed a speculative draft to finalize the discussion in the group in the near future.

This stresses several points which the government and the pharmaceutical industry should do to rapidly provide effective and safe drugs to patients. For instance, the draft urges the government to utilize micro-dosing systems and to develop biomarkers in order to modernize and accelerate drug approval reviews. The draft report also asks pharmaceutical manufacturers to change their strategy for clinical trials where overseas development precedes domestic evaluation when promising drug candidates are discovered.

The draft also calls for the improvement of warnings on package inserts and the implementation of educational PIs for physicians and pharmacists because they are apt to neglect important issues described in these in their daily medical and pharmaceutical practices.