加拿大原料药MF的AP和RP

Dora-Cheng

Appendix G: Distribution of MF Information between the Applicant and Restricted Parts， Preparation of Regulatory Activities in the “Non-eCTD Electronic-Only” Format

3.2.S.3.2， RP下的解释为：Insofar as the information is related to the detailed description of the manufacturing process and the MF Owner sufficiently justifies that there is no need to control these impurities in the final drug substance.

3.2.S.4.5， RP下的解释为： Insofar as the information is related to the detailed description of the manufacturing process, control of materials and process validation.

问题：个人理解如果上述信息和保密工艺有关的话，就应该列为RP中，AP不需提供，但是看法规的描述好像是反着的。请大家帮忙确定这两部分内容应如何体现在加拿大MF中，仅列在AP中？RP中？还是根据保密程度的要求分别撰写，AP和RP都提交？

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英文看不懂