Present systems and future needs for risk assessments of biologicals: the perspective of the regulator in the People's Republic of China.
Regulation of veterinary biologicals in the People's Republic of China is governed by the Animal Drug Administration Regulations issued by the State Council in 1987. These regulations authorize the Ministry of Agriculture to prescribe requirements governing the production and marketing of veterinary biologicals shipped into, within or from China. The goal of the veterinary biologicals programme is to ensure that all veterinary biological products are pure, safe, potent and effective. The programme is based on review, licensing, inspection and post-licensing testing. Risk assessment procedures and requirements for biotechnology-derived veterinary biologicals have been established. China needs international harmonization of trade in veterinary biologicals and will make a great contribution in this field.
Xia
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Y
National Institute for the Control of Veterinary Bioproducts and Pharmaceuticals (NICVBP), Beijing, People's Republic of China.
Zhang
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Z
Li
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M
D000818:Animals; D001688:Biological Products / Q000009:adverse effects / Q000592:standards*; D001709:Biotechnology / Q000592:standards; D002681:China; D006801:Humans; D007880:Legislation, Drug; D007886:Legislation, Veterinary; D008004:Licensure; D011786:Quality Control; D018570:Risk Assessment
D001688:Biological Products