Japan AE (Adverse Event) Reporting Requirements

[jinglot]

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!!!

 

[Ajit Basrur]

Did you check this GHTF document?

Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan

Also refer this article for more info - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4588369/
.

 

[jkc3usc]

Does anyone have a Decision Tree for Japan? Looking to put one together for decision making on reporting.

Thanks!

 

[jkc3usc]

Nobody uses a decision tree / flow chart when deciding to report to Japan?

 

[April]

Did anyone ever create a decision tree for Japan? I am having a difficult time finding all the regulations?

 

[April]

Does anyone have a Decision Tree for Japan? Looking to put one together for decision making on reporting.

Thanks!

Did anyone ever create a decision tree for Japan? I am having a difficult time finding all the regulations?