按照申报经验来说，建议你提供这些数据，如果确实由于什么原因不可以提供，可以提前在Pre-IND中与FDA沟通确认。

FDA申报IND时，原料药和制剂的中控和中间体数据的要求是分阶段（phase-appropriate）的，并非所有细节都需要在初始IND中完整提供。核心原则来自21 CFR 312.23(a)(7)：信息量取决于临床阶段、研究持续时间、剂型以及已有数据，目的是确保受试者安全（identity, quality, purity, strength）。早期强调原料和原料药的识别与控制，最终规格到开发后期才预期完整。

 具体有一个PPT文件可以参考，你可以下载学习一下 化学、制造与控制：早期临床开发的要求。

先上结论：法规没有特别具体的说明，但是我们化药实践上是有在IND提供中间体和中控数据的，建议提供。

具体而言：

FDA网站对于IND要求中，制剂部分与中控、中间体数据可能相关的内容就是如下。可见流程图、工艺描述、检测（原文写的是as well as other relevant tests, as appropriate for the product，这个说法就有可能包括中控）、制剂标准、临床批coa、接受标准和分析方法是要求提供的。没有具体提到中控数据或中间体数据要求。

Drug Product

• Brief general description of the manufacturing process (in the form of a flow diagram is suggested) and packaging procedure, as well as other relevant tests, as appropriate for the product. Final specifications for the drug product intended to be used in toxicological and clinical studies should be included. For injectable products, sterility and pyrogenicity tests, endotoxin levels and particulate matter should be included. Submitting a copy of the certificate of analysis of the clinical batch is also suggested.

• The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug product.

原料药部分，则是要求提供制备方法、详细流程图、接受标准、分析方法、CoA等。也是没有具体提到中控数据或中间体数据要求。

Drug Substance

• Description of the general method of preparation of the drug substance, including a list of the reagents, solvents, and catalysts used. A detailed flow diagram is suggested as the most effective presentation. More information may be needed to assess the safety of biotechnology-derived drugs or drugs extracted from human or animal or plant sources.
• The acceptable limits and analytical methods used to ensure the identity, strength, quality, and purity of the drug substance, with a brief description of the test methods used (e.g., Nuclear Magnetic Resonance, Infrared, UV spectra to prove the identity, and High Performance Liquid chromatograms to support the purity level and impurities, etc). Submission of certificates of analysis is also suggested.

建议提供。现在申报IND基本都是参照ICH M4Q的CTD结构来撰写，结合我们已成功申报项目的实践，均在3.2.S.2.4章节（原料药/原液）及3.2.P.3.4章节（制剂）中递交了中控检项及相应可接受标准，在3.2.S.2.6章节和3.2.P.2.3章节提供了已生产批次对应的中间体及中控的检测数据。

需要提供，中控和关键中间体数据都是非常关键的信息。