Japan Mistry of Agriculture, Forestry and Fishery (JMAFF) have announced partial amendments of Pharmaceutical Affair Law in field trials requirements of biologicals and fluoroquinolone antibiotics. Before the change, one Japanese site of field trials was mandatory for registration for biologicals and fluoroquinolone antibiotics. It is acceptable for JMAFF that the data of field trial are in accordance with field trial standards of FDA, EMA and APVMA. It is necessary to explain that animals and disease of the trial can be extrapolated scientifically. It is same condition for acceptance of data for pharmaceutical products.