FDA公布已批准变更的可比性方案应用指南草案

翻译：julia 来自：蒲公英

GMP News

27/04/2016

FDA releases draft guidance on the use of comparability protocols for post approval changes

FDA公布已批准变更的可比性方案应用指南草案

On April 19, 2016, the US Food & Drug Administration (FDA) released a draft guidance for industry 'Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information'. Comments and suggestions regarding the draft guideline should be submitted within 60 days of publication.

2016年4月19日，美国FDA公布了行业指南”人用药品和生物制品可比性方案：CMC信息“草案。对于指南草案的意见和建议应在公布之后 60天内提交。

The guidance replaces the draft guidance published in February 2003. It provides recommendations on implementing postapproval changes through the use of comparability protocols (CPs). A CP is a comprehensive, prospectively written plan for assessing the effect of proposed CMC postapproval changes on the identity, strength, quality, purity, and potency of a drug product or a biological product. Using a CP in an original application or prior approval supplement (PAS) will, in many cases, facilitate the subsequent implementation and reporting of CMC changes. This could result in moving a product into distribution or facilitating a proactive approach to reinforcing the drug supply chain sooner than without a submitted protocol.

该指南取代了2003年公布的指南草案。它为使用可比性方案（CP）实施批准后变更提供了建议。CP是一份提前写就的书面综合性书面计划，用于评估所拟CMC批准后变更对药品或生物制品鉴别、课题、质量、纯度和效价的影响。在原始申报或批准前申报（PAS）中使用CP，在许多情形下，会有助于之后的实施，以及CMC变更的报告。这可能会使得药品可以进入销售，或者有助于加快构筑药品供应链。

The guidance emphasizes that it is intended to establish a framework to promote continuous improvement in the manufacturing of quality products by encouriging applicants to employ tools of  ICH Q8 to Q11:

指南强调说其意在建立一个框架，通过鼓励申报者实施ICH Q8至Q11中一些工具，推进生产中对药品质量的持续提高：

Effective use of knowledge and understanding of the product and manufacturing process;

有效使用产品和生产工艺知识和了解；

A robust control strategy;

强有力的控制策略；

Risk management activities over a product?s life cycle;

整个药品生命周期中风险管理活动；

An effective pharmaceutical quality system.

一个有效的药物质量体系。

An FDA approved submission containing a CP provides an applicant with an agreed-upon plan to implement the proposed change(s), and in many cases, justification to report the implementation of the proposed change(s) in a reduced reporting category.

一份经过FDA批准包括一份CP的申报可以为申报者提供一份已经同意的计划，用以实施所拟的变更，在许多情形下，可以降低一个报告级别来申报所拟变更的实施。

FDAs recommendations for the CP content: The CP submission should provide a comprehensive, detailed plan for the implementation of proposed changes and should include the information described below:

FDA给CP目录提出了建议：CP申报应提供一份全面详细的实施所拟变更的计划，应包括以下所述信息：

Summary;

总结；

Description of and Rationale for the Proposed Changes;

所拟变更描述及其合理性；

Supporting Information and Analysis (based on knowledge and risk assessments, information from development);

支持性资料和分析（基于知识和风险评估、研发信息）；

Comparability Protocol for the Proposed Change(s) - the CP should describe the specific tests and studies to be performed, including analytical procedures to be used and criteria to be achieved for the expected results. The level of detail that should be provided will depend on the complexity of the change and the specific risks associated with the change to product quality;

所拟变更的可比性方案—CP应描述将要实施的具体测试和研究，包括将要使用的分析方法和期望结果达到的标准。详细程度取决于变更的复杂程度，以及变更对产品质量的特定风险；

Proposed Reduced reporting category (i.e., an annual report, CBE, or CBE-30);

所拟降低级别的申报类型（即，年报、CBE、或CBE-30）；

Other Information.

其它信息。

Additionally, the draft guidance provides a 'Questions and Answers' section on CPs in the Appendix, which covers general questions and questions regarding formulation, manufacturing site and process, specification (including analytical methods), packaging, and process analytical technology (PAT) changes.

另外，指南草案在附录中提供了一份CP“问答“，其中覆盖了一般问题和关于配方、生产场所和工艺、质量标准（包括分析方法）、包装和过程分析技术（PAT）变更方面的问题。

CPs together with 'established conditions' may be effective tools for the overall product life cycle management. They can also facilitate the management of post-approval CMC changes in a more predictable and efficient manner, as it is the intention of the planned ICH Q12 Guideline 'Lifecycle Management'. Steps 1 and 2 a/b of ICH Q12 are expected for June 2017.

CP与”既定条件“一起可能会成为整个药品生命周期管理的有效工具。他们还有助于以更高效率和可预见方式实施批准后CMC变更的管理，因为这也是计划中的ICH Q12指南”生命周期管理“的目的。ICH Q12预期于2017年6月会达到第1阶段和2a/b阶段。

For more information please visit the ICH website and see the FDA draft guidance for industry 'Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information'.

更多信息参见ICH官网和FDA官网。