Drug Evaluation Committee Forms for Communication of Safety Information to Medical Institutions Conducting Clinical Trials Recommended by the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Clinical Evaluation Subcommittee
April 2022
The Pharmaceutical Manufacturers Association of Japan (PMAJ) recommends a form for communicating safety information to investigational sites. In addition to the "Common Line List for Individual Reporting Recommended by the Pharmaceutical Manufacturers Association of Japan (PMAJ)," which has been used for some time, the "Common Summary Table for Individual Reporting Recommended by the PMAJ," which was newly introduced at the "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act - Impact on Clinical Studies by the Introduction of Investigational Products -" held on February 22, 2022, is available. has been posted on our website.。
In accordance with the revised Pharmaceutical Affairs Law, the Notice (*) regarding materials to be submitted immediately prior to the investigation for the new drug GCP onsite survey and written conformity survey has not been revised. As in the past, a list of the progression up to the provision of adverse drug reaction information to the investigational sites is still required.
(*): Appendix 2, "Procedures for Conducting Documentary Conformity Surveillance and GCP On-site Surveillance for Drug Application Materials, and Conducting Documentary Conformity Surveillance and GPSP On-site Surveillance for Drug Application Materials for Interim Evaluation, Re-Evaluation and Reassessment (NHI No. 0831001, August 31, 2020)", Survey of Applicants and Sponsors (Document 5) Clinical study part 4 (only for medical institutions subject to GCP on-site investigation) (iii) "List of progress from the acquisition of information on serious adverse drug reactions notified by the sponsor to the investigational site under investigation based on GCP Article 20 to the provision of information to the investigational site under investigation" (Japanese only)
References
- Briefing on the Revised Pharmaceuticals and Medical Devices Act -Impact of the Introduction of Investigational New Drugs on Clinical Trials-" held on February 22, 2022
- Briefing on the Revised Pharmaceuticals and Medical Devices Act -Responses, etc. required of pharmaceutical companies based on notifications and examples-", held on February 22, 2022
Deliverables of the Drug Evaluation Committee Return to list of all deliverables