Drug Evaluation Committee Notes on Regulatory Revisions Concerning Handling of Safety Information for Investigational Products in Clinical Trials
Clinical Evaluation Subcommittee
August 2023
In accordance with the revision of the Pharmaceutical Affairs Law, the systems for notification of clinical trial plans and reporting of adverse drug reactions in clinical trials were reformed, which came into full effect on September 1, 2022.
This regulatory revision introduces the concept of investigational new drug and further clarifies the objects that should be monitored for safety during a clinical trial by the sponsor or investigator. It is now important for those involved in handling safety information in clinical trials to ensure the safety of trial participants and the science and reliability of clinical trials by appropriately understanding the changes in the relevant notifications associated with the regulatory revision and reporting safety information to the regulatory authorities and the investigational sites without delay.
In light of this situation, we have compiled the notifications issued as a result of regulatory amendments and prepared a document explaining the operation (handling of adverse drug reaction reports) for smooth implementation of clinical trial safety reporting to the regulatory authorities and the investigational sites.
We hope that this document will help those involved in handling clinical trial safety information to have a common understanding and to carry out their duties.