Optimum use of generic products would require equivalence, not only in terms of quality, safety, and efficacy in clinical studies, but also patient acceptability to not jeopardize treatment success because of non-adherence which would de facto limit the potential cost saving anticipated by their use. Although acceptability is a requirement for the authorization of pediatric innovator products, a survey of European Union (EU) regulatory authorities showed that few have a formal process for assessing patient acceptability of generic products during the registration processes. The current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on unifying guidance for the development and scrutiny of generics but should include acceptability alongside the other factors being considered for harmonization.

仿制药的最佳使用需要等效，不仅在临床研究中的质量、安全性和有效性方面，而且在患者可接受性方面不会因为事实上的不依从而危及治疗成功限制其使用预期的潜在成本节约。尽管可接受性是儿科创新产品授权的一项要求，但欧盟 (EU) 监管机构的一项调查表明，很少有正式的流程在注册过程中评估患者对仿制药的可接受性。当前的国际人用药物技术要求协调委员会 (ICH) 侧重于统一仿制药的开发和审查指南，但应包括可接受性以及正在考虑进行协调的其他因素。