FDA,WHO和EMA关于基于生物药剂学分类系统的生物等效性豁免指导原则的比较

Comparison and discussion of FDA,WHO and EMA guidelines on BCS-based biowaiver

本文比较了FDA,WHO和EMA各自发布的关于基于生物药剂学分类系统(biopharmaceuticsclassification system,BCS)的生物等效性豁免的指导原则。结果表明它们的基本理念都源于Amidon等提出的BCS理论,因此豁免的基本原则和考虑因素保持一致,但一些重要概念和豁免标准存在较大差异,WHO和EMA拓宽了FDA关于生物豁免应用的范围。文中总结了运用基于BCS的生物等效性豁免时需考虑的主要因素并进行了讨论,希望有助于深入理解这一科学理念并尽快在中国实施。

This article compares the guidelines issued respectively by FDA,WHO and EMA.The results show that their basic principles and considerations on biowaive are same because their theoretical basis are from the same BCS theory proposed first by Amidon et al.However different agencies hold different points on some important concepts and biowavier criteria which let WHO and EMA broaden the scope of application of biowaiver.This paper summarizes the factors needed to consider when applying BCS based biowavier,hoping to help the Chinese regulatory agency and pharmaceutical companies to deeply understand and implement these scientific concepts as soon as possible.