首先，根据21CFR 312.23的7(iv)(b)，其中涉及辅料和包装的内容要求如下，并没有明确要求要提交辅料或者包装的CoA。

A list of all components, which may include reasonable alternatives for inactive compounds, used in the manufacture of the investigational drug product, including both those components intended to appear in the drug product and those which may not appear but which are used in the manufacturing process, and, where applicable, the quantitative composition of the investigational drug product, including any reasonable variations that may be expected during the investigational stage; the name and address of the drug product manufacturer; a brief general description of the manufacturing and packaging procedure as appropriate for the product; the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the drug product; and information sufficient to assure the product's stability during the planned clinical studies. Reference to the current edition of the United States Pharmacopeia—National Formulary may satisfy certain requirements in this paragraph.

其次，根据FDA指南新药Ⅰ期临床试验申报资料的内容及格式要求，这里面只提到制剂产品及API建议提交CoA，并没有具体说P4、P7要不要提供CoA。

因此，根据指南、法规，是没有强制要求提供辅料（新型辅料除外）、包装的CoA的。不过，就我个人的化药IND初始递交的实际经验来说，还是会放辅料、初级包材的CoA的。供参考。