The 145th Annual Meeting of the Pharmaceutical Society of Japan (Fukuoka)

Organizer: Wakabayashi Susumu (Kyorin University Hospital), Yuji Kashitani (Takeda Pharm.)

The review report is a document compiled by the PMDA for approval review of pharmaceuticals and other products. It summarizes discussions and evaluation results of quality, non-clinical, and clinical trial results submitted by applicants. The report is publicly available on the PMDA website and contains info on impartially reviewed pharmaceuticals. It is used by pharmaceutical companies, medical institutions, and pharmacies to understand characteristics, effectiveness, safety, and key issues in approval review. However, the focus is on main issues for approval and may not include sufficient useful info for utilization. Additionally, while the page count is high, info provided is limited. Therefore, there is room for improvement in its structure to make it easier for readers to understand and more efficient for PMDA reviewers.
In this symposium, we will present the composition and positioning of the review report as considered by the PMDA, as well as the actual utilization of the review report and desired content based on survey results targeting hospital pharmacists. From the industry perspective, we will present the examination results based on a survey by the Japan Pharmaceutical Manufacturers Association, the current challenges of review report content, and future expectations. Based on these opinions, we would like to have a positive discussion on the future direction of pharmaceutical review reports.