CHEMISTRY MANUFACURING AND CONTROLS (CMC) REQUIREMENTS FOR A CLINICAL TRIAL APPLICATION FOR BIOLOGICS
And
CMC CHANGES TO GRANTED CLINICAL TRIAL PERMISSIONS
I.
This document summarizes the CMC (Chemistry, Manufacturing and
Controls) information recommended to be submitted by the sponsor
for approval by the Health Authority prior to beginning a clinical
trial involving a biological medicinal
product.
This document provides information that would typically be
expected for an investigational product as part of a clinical trial
submission. Given the variety of acceptable approaches that can be
applied during product development to ensure the proper identity,
strength or potency and purity of the drug substance and drug
product, it is understood that the eventual content and timing of
the information provided can vary and is ultimately dependent on
the phase of the investigation, the extent of the human study, the
duration of the investigation as well as the nature and source of
the drug substance and the drug product dosage
form.
II.
The goal of the CMC information in the Clinical Trials
submission is to demonstrate that the quality of the biological
medicinal product is suitable for its intended purpose and to
address those attributes that may impact patient safety (e.g.,
microbiology, viral safety).
简介
本文件总结了建议由申办者在涉及生物药品的临床试验开始前，为获得卫生部门批准而递交的CMC（化学、生产和控制）信息。
本文件提供了通常可从试验xx中获得的信息，做为临床试验申请的一部分。考虑到在药品研发过程中可以采用多种可接受的方法以保证原料药和药品的合理特性、规格或效价、以及纯度，可以理解所提供的信息的最终内容和时间有所差别，最终应视研究阶段、人体试验程度、研究持续时间、以及原料药性质或来源、和药品剂型而定。
II.CTA中CMC信息的目的
临床试验申请中的CMC信息的目的是证明生物药品的质量与其指定用途相匹配，并且阐明可能影响患者安全的特性（例如：微生物、病毒安全）。安全性问题通常与药品作用机制或免疫原性相关，而非与毒性杂质相关。在研发过程中，生物药品经过数项临床试验的测试，并使用通过不同工艺生产出的药品。在所有临床阶段中，申办者均应负责确保生物药品的可用性。
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