20150218 ECA新闻：法规申报资料中的风险分析要求：EMA和FDA的建议

20150218 ECA新闻：法规申报资料中的风险分析要求：EMA和FDA的建议  

2015-02-27 20:10:11|  分类： ECA新闻

GMP News
18/02/2015

Requirements for Risk Analyses in the Regulatory Submission Dossier: EMA's and FDA's Recommendations

法规申报资料中的风险分析要求：EMA和FDA的建议

The EMA has published a new question & answer-(Q&A) paper together with the FDA at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Among other things it answers questions on the topic risk analysis.

EMA于2014年年底与FDA一起刚公布了一个新的问答资料。该文件回答了关于法规申报资料的详细程序的要求的问题。其中，它回答了关于风险分析的问答。

To the question "What types of risk assessments can be included in a regulatory submission?" the document provides a very pragmatic answer: It is up to the applicant himself to determine this. But it is stated explicitly that this information can be useful to aid the assessor/reviewer for determining how the applicant selected the specific formulation, manufacturing process and controls. The document mentions that the Agencies have seen risk assessments that have been used for the selection of in-process controls for example.

对于“哪些风险评估（RA）类型可以包括在法规申报文件中？”的问题，文件提供一个非常实际的回答。它取决于申报者自己。但其中也清楚说明了，这些资料可能有助于评审员知道申报者是如何来选择特定的处方、生产工艺和控制。文中提到了例如官方已看到了风险评估用于选择中控。

The question "What level of detail should be considered for a risk analysis related to process design in a regulatory submission?" is answered more precisely in the document. In the beginning the answer is rather general: The level of detail should be commensurate with the significance of the outcome of the risk analysis to the commercial manufacturing process and to the control strategy. Taking the example of a critical process step the document gives more concrete information. This information should contain the following:

文中对问题“在法规申报文件中工艺设计相关的风险评估要考虑到何种详细程度？”的回答更为精确。在刚开始，回答是有点笼统的。详细程度应与商业生产工艺和控制策略RA结果的重要性相等同。文件以关键工艺步骤为例给出了更详细的信息。该信息应包括以下：

• A statement of which risk analysis tool was used. If a novel risk analysis tool was used, a definition of this method along with an example of its use should be included.
• 一份使用了哪些风险评估工具的声明，或如果使用了一个新的RA工具，该RA工具与工具中输出样品的定义
• A comprehensive qualitative or quantitative summary of the outcome of the risk analysis (e.g. the risk priority number).
• RA结果的定性或定量综述（例如，RPN（风险优先号）
• The threshold value for the risk priority number (and an explanation for why such a threshold was chosen) leading to the selection of variables/parameters that warranted further study.
• 导致选择出变更/参数用于进一步研究的风险优先序号阈值（和一个为什么选择该阈值的解释）
• A list of all risk priority numbers.
• 所有风险优先序号清单
• Information on the way in which risk assessment activities were used to determine which process parameters and quality attributes are to be considered critical or non-critical.
• 使用风险评估活动来决定哪些工艺参数和质量属性被认为是关键的或非关键的信息。
  

Interestingly, the document also contains a notice to the regulators themselves. These should take the following into consideration before requesting additional details regarding a risk analysis: complexity of the dosage form, the commonality of the risks identified relative to products of the same type, and the amount of commercial scale manufacturing data available.

有意思的是，文件中还包括了一个对法规人员自己的通知。在要求关于风险评估的更多详细资料前，应考虑以下内容：剂型的复杂程度、相对于同类药品已识别的风险的通用性，以及可获得的商业规模生产数据的数量。

The answer to the question "What level of detail should be considered for a risk analysis related to product design in a regulatory submission?" is similar to the answer to the question on process design: The level of detail should depend on the risk presented by the formulation and dosage form. In the case of the product design, however, the topic "misuse" should also be taken into consideration. As an example a solid modified release oral formulation for an opioid is mentioned.

对问题“法规申报中产品设计相关的RA要考虑的内容详细程度应如何？”的回答类似于对工艺设计的回答：详细程度应取决于处方和剂型所代表的风险。如果是产品设计的话，则“误用”的问题也要进行考虑。在其中提到了类鸦片的口服固体改释制剂的例子。

For further information please see the complete "Questions and answers on level of detail in the regulatory submissions".

更多信息参见完整版本。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201512611566211/

好资料，好好学习