Japan AE (Adverse Event) Reporting Requirements

jinglot

Starting to get Involved
#1
Hi! I am finding conflicting information online and not much in English regarding reporting requirements in Japan. Some main questions:

1. Are AEs outside of Japan reportable to PMDA?
2. Are AEs that are already provided in labeling reportable?

If anyone has a decision tree that they are willing to share, that would be super helpful as well...

Thank you in advance!!!
 

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