申请上市许可的生物技术衍生药品(以及化学合成衍生的类似产品)临床前生物安全性测试的申请人须知

Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety of Medicines
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Notes to applicants for marketing authorizations on the pre-clinical biological safety testing of medicinal products derived from biotechnology (and comparable products derived from chemical synthesis)
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