Differences among Approval, Designation, and Registration
Veterinary drugs, feed additives, and agricultural chemicals have respective application systems under different laws even though all these products similarly need applications accompanied by the following data; veterinary medicine needs an approval system, feed additives need a designation system, and agricultural chemicals need a registration system. Now, let me briefly explain these differences.
In the case of veterinary drugs, business entities make applications accompanied by various data about the products under the Pharmaceuticals and Medical Device Law, after that they are scientifically examined in the Pharmaceutical Affairs and Food Sanitation Council, and then approved. On the other hand, feed additives are applied under another law: the Act on Safety Assurance and Quality Improvement of Feeds. Based on various data submitted by business entities, the Agricultural Materials Council examines their effectiveness and safety for livestock animals, thus, the country designates the ingredients which are regarded as necessary for promotion of livestock industry. Furthermore, in agricultural chemical, business entities apply for the products accompanied by various data under the Agricultural Chemicals Control Act. After that these products are examined scientifically by the Agricultural Material Council, and then registered.
In other words, the necessary ingredients in feed additives are designated mainly by the country. On the other hand, products of agricultural chemicals are applied by business entities, and evaluated scientifically and registered. Thus, the latter is done mainly by business entities.