Drug Evaluation Committee Points to keep in mind regarding regulatory amendments for reporting of adverse drug reactions, including periodic reporting (revised version)
May 2014
We have prepared a revised version of "Points to Keep in Mind for Regulatory Revision of Adverse Reaction Reporting, Including Periodic Reporting, etc." which was posted on the relevant website in November 2013.
The following revisions have been made in this document.
- Reflects the contents of the Notice of the Director of the Second Section and the Notice of the Director of the Third Section regarding safety issued on September 17, 2013.
- Includes examples of ideas and responses to questions raised during and after the "Symposium on Clinical Trial Safety" held in December 2013, which introduced key points of the contents of the document.
- Examples of the transition from six-month periodic reporting to annual reporting by JPMA participating companies are included.
- Explanation on the preparation of DSUR based on the ICH E2F guidelines is added.
The revised version of the document also includes the following revisions: (1) The revised version of the "Points to Consider in Revising Regulations Concerning Adverse Reaction Reports, Including Periodic Reports" has been updated to reflect the questions raised at the "Symposium on Clinical Trial Safety," and the revised version includes the relevant item numbers, and the ideas and responses to other items.
As in the previous version, this document has been supplemented with additional information based on the JPMA members' discussions with the relevant departments regarding the introduction of the new regulations, picking up points to be noted in the implementation of the new regulations. For a more accurate understanding of the contents of the notification, we have supplemented the background of the discussions leading up to the description of the notification.
We have also included, as necessary, matters that we believe can be further interpreted/implemented through discussions with the relevant departments.
We hope that this document will be used to facilitate the smooth implementation of clinical trial safety information operations based on the new regulatory requirements.