Comparison And Analysis Of Registration Authorisation Regulation Of Veterinary Biological And Drug Product In U.S.A, EU And China

There are many different administrant regulations of veterinary biological and drug products licensing authorization in the United States of America, EU and China. Primarily they are showed on authority agency, legal basis and requirement of the dossiers. Administration of veterinary biologic and animal drug in the United States of America is belongs to two agency: APHIS-CVB and FDA-CVM. Mostly the legal basis for product licensure include: VST Acts, 9CFR ,VSM, Federal Food, Drug, and Cosmetic Act, 21CFR etc. The European medicines evaluation agency for product used in animal is EMEA-CVMP. The legal basis on three director (81/851/EEC, 81/852/EEC, 2001/82/EEC) and one regulation (2309/93/EEC). Chinese MOA Animal Medicine and Instrument of Husbandry and Veterinary Bureau in charge of licensure of animal medicine product. OVPC of MOA in charge of evaluation. And IVDC in charge of testing sample. The requirements of dossier contents for licensing application are different in U.S.A, EU and China. This dissertation explains the dossier detailedly include: the dossier requirements of veterinary domestic, import product and animal drug product in U.S.A. The dossier requirements of immunological medical product, Medicine product and unimmunological medical product in EU. And Chinese dossier requirement of domestic new veterinary biological and drug product, import eterinary biological and drug product.From comparison and analysis of evaluation procedure, evaluation supporting system, relation between single vaccine and multi-vaccine, experts reports and dossier, combine with the status of China product registration, give out suggestion to improve registration regulation in China.