This may not relate specifically to N-NOs but in a recent interaction with PMDA reference was made to an update to guidance:
- Q26 of “Revision of the Q&A on Plan Notifications and Conduct of Clinical Trials on Medicinal Products” (Administrative Notice, August 31, 2022).
Is anyone on this forum aware of this ?
This is the document in Japanese that you mentioned.
Q26 means how to submit the result of hazard assessment for drugs used for clinical trials. It includes the example of drugs for ph-2b clinical trials. Synthetic scheme of API and DP and figures with qsar results, classification and analytical test results are there.
I am sorry I am not sure where is the document in English.
English Translation of Q26 and Answer:
Section 9 of the M7 guideline states that “Information related to this guideline must be presented
at each stage below.” However, materials regarding the evaluation and control of DNA reactivity
(mutagenicity) impurities must be submitted in the clinical trial protocol notification. Is it okay to attach it to the document?
No problem. In addition, if the clinical trial plan related to the notification corresponds to a Phase IIb study or a Phase III study, a manufacturing process flowchart for the drug substance and drug product manufactured in accordance with investigational drug GMP should also be attached. . In addition, regarding the evaluation results regarding the mutagenicity of impurities, please prepare materials with reference to the examples below.
In addition, if these materials are to be attached to the clinical trial protocol notification, please enter the name of the document ``Data related to the evaluation and control of DNA reactivity (mutagenicity) impurities’’ in the notification attachment column of the clinical trial protocol notification. Please write as follows.
(Example) For Phase IIb and later studies
Figure 1. Flowchart of manufacturing process for drug substance
Figure 2. Pharmaceutical manufacturing process flow chart
I hope this can help…
English translation using DeepL (Deep learning translator)
000248031 en.pdf (249.4 KB)