Drug Evaluation Committee Handling of Safety Information in Clinical Trials Considering Appropriate Management of Off-label Control Drugs, Concomitant Drugs, etc.
Clinical Evaluation Subcommittee
December 2020
Handling of Safety Information in Clinical Trials: Considering the Appropriate Operation of Off-label Controls and Concomitant Drugs
The Clinical Evaluation Committee of the Committee for Drug Evaluation held a meeting on March 27, 2018 to consider the handling of safety information of off-label control drugs and concomitant drugs in clinical trials.
This meeting was planned in response to the recent increase in the use of drugs that have already been approved overseas as control or concomitant drugs outside the scope of domestic approval, and the fact that the law does not clearly specify the handling of safety information for drugs used other than the study drug. These control drugs, concomitant drugs, etc. were sometimes referred to as "unapproved control drugs, concomitant drugs, etc." in the past, but this time they are described as "off-label control drugs, concomitant drugs, etc.".
The results of the survey conducted by the Pharmaceutical Manufacturers Association of Japan (PMAJ) and a session to discuss this issue was held with the cooperation of the MHLW's Drug Evaluation and Review Administration Division and the PMDA's Review Management Division. We hope that the examples shown in the slides will be of some help to your company.
Addition: "Summary of Handling of Off-label and Concomitant Drugs, etc." and "Example of Reminder Letter
Summary of Handling of Off-label/Concurrent Drugs, etc. (209KB)
Note: The examples of the reminders can be used only when the safety information is notified in accordance with the enforcement regulations and GCP ordinances prior to the enforcement of the Ministerial Ordinance Concerning Maintenance, etc. of Relevant Ministerial Ordinances in Connection with the Partial Revision of the Act on Quality, Efficacy and Safety Assurance, etc. of Pharmaceuticals and Medical Devices (Ministerial Ordinance No. 155 of the Ministry of Health, Labour and Welfare, 2020). The following is an example of a reminder letter.
Example of a Letter of Intent (49KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables