J
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!!!
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!!!