Relaxation of policy to obligate to turn in bioequivalence test data on drug reassessment

Data of bioequivalence tests must have been turned in reassessment of drugs so far, but a regulation will be relaxed that it need to conditionally be turned in depending on target products for the reassessment.

The Ministry of Food and Drug Safety announced a policy to turn in bioequivalence test data in any circumstance as a material for drug reassessment will be amended to a conditional opti...