【讨论】Different for Generics and Innovator Product（中英）

zhulikou431

Different Storage Conditions and Stability Characteristics for Generics and Innovator Product: Is that allowed?
It may happen - in the development of generic medicinal products - that the in-use stability properties or the storage conditions deviate from those of the innovator product. The question whether this is basically allowed or only allowed with restrictions in the context of the application for authorisation of a generic product has been answered by the EMA and put on its updatedQ&As webpage. The answer to the following two questions was published as supplement to the Q&As:
"Is it allowed that the in-use stability of one product deviates from other authorised products (e.g. regarding storage time, storage conditions)?
Is it allowed that the storage condition of one product deviates from other authorised products (e.g. storage in refrigerator versus storage at temperatures not exceeding 25°C)?"
The EMA clearly states in the answer to both questions "each product will be assessed on its own merits". At the same time, the EMA takes into consideration whether differences in in-use stability and/or storage conditions potentially could lead to detrimental medication errors (wrong dosing). In such a case, the EMA cannot accept the differences and will delay the treatment of the application until the problem has been solved. In its answer, the EMA refers to a position paper of the CHMP which discusses medication errors caused by differences between generics and innovator products. This position paper is dated 30 May 2013 and its title is "Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures". The different in-use stability and storage conditions aren't explicitly addressed in the document. That's the reason why the EMA felt compelled to clarify those questions in the Q&As.

zhulikou431

1. Is it allowed that the in-use stability of one product deviates from other authorised products (e.g regarding storage time, storage conditions)? H+V March 2014
是否允许一个产品的使用过程中稳定性要求不同于其他批准的产品（例如，关于储存时间、储存条件）？
In principle, each product will be assessed on its own merits and differences may exist. However, when the difference in inuse stability and/or compatibility potentially leads to detrimental medication errors in daily practice, such a difference cannot be accepted. Each difference will be assessed in relation to the products at issue and the context in which the products are used, in line with the CHMP position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures, EMA/CHMP/277591/2013. Although the CHMP position paper relates only to medicinal products for human use, the same principles can be applied if necessary to veterinary medicinal products when there is a known or demonstrated potential for medication errors.
原则上，每个产品应该基于自己的特点被评估，而且差异是可能存在的。然而，当差异存在于使用过程中稳定性方面，和/或相容性方面，在日常实践中，可能导致不利的医疗失误，这样的差异是不能被接受的。每个差异将结合产品使用的环境和在产品签发时被评估，并考虑CHMP的关于药品效益-风险平衡和风险最小化措施的中的潜在用药失误的立场文件（EMA/CHMP/277591/2013）。尽管CHMP立场文件仅仅人用药品相关，当存在已知的或者证实的潜在用药失误时，如果必要的话，这个相同原则也适用于兽药。

zhulikou431

2. Is it allowed that the storage condition of one product deviates from other authorised products (e.g. storage in refrigerator versus storage at temperatures not exceeding 25°C)? H+V March 2014
是否允许一个产品的储存条件不同于其他批准的产品（例如储存于冰箱条件vs储存于不超过25℃的温度下）？
In principle, each product will be assessed on its own merits and differences may exist. However, when the difference in storage temperature potentially leads to detrimental medication errors in daily practice, such a difference cannot be accepted. This will be assessed on a case by case basis in relation to the products at issue and the context in which the products are used, in line with the CHMP position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures, EMA/CHMP/277591/2013. Although the CHMP position paper relates only to medicinal products for human use, the same principles can be applied if necessary to veterinary medicinal products when there is a known or demonstrated potential for medication errors.
原则上，每个产品应该基于自己的特点被评估，而且差异是可能存在的。然而，当差异存在于储存条件，在日常实践中，可能导致不利的医疗失误，这样的差异是不能被接受的。每个差异将结合产品使用的环境和在产品签发时被评估，并考虑CHMP的关于药品效益-风险平衡和风险最小化措施的中的潜在用药失误的立场文件（EMA/CHMP/277591/2013）。尽管CHMP立场文件仅仅人用药品相关，当存在已知的或者证实的潜在用药失误时，如果必要的话，这个相同原则也适用于兽药。

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