欧盟有关生物技术通用名药法规进展

随着第一代生物技术药物接近专利保护期满,欧盟发布了一系列针对生物技术通用名药的法规,针对该类药物的复杂性,力争将应该进行的试验减至最少.现综述欧盟有关生物技术通用名药的法规,包括欧盟人用药品2001/83/EC和2004/27/EC法令、生物技术蛋白质为活性成分的药品等效性指导方针、生物技术药物/生物制品制造过程中的变化的指导方针说明.

Regulatory status of biogenerics in European Union

With the imminent expiration of patent protections for the first generation of brands of biotech drugs, the regulatory criteria to approve the generic substitutes are becoming an important affairs demanding prompt solution. Because of the complexity involved in the generation of such biotech drugs, it is essential to validate most of pilot processes to manufacture the generic bio-substitutes, which seems not the same approval criteria as traditional generics. Current legislation has been discussing how to minimize the validation of the relevant processes. This paper summarized the regulatory status regarding standardization of biogenerics in European Union.