Host: The Japanese Society of Toxicology
Name : The 51st Annual Meeting of the Japanese Society of Toxicology
Date : July 03, 2024 - July 05, 2024
The PMDA evaluates new drugs from various angles, including quality, non-clinical, and clinical, in accordance with the "Act on Quality, Efficacy and Safety Assurance of Drugs and Medical Devices" (Pharmaceutical Affairs Law). Our purpose is to ensure the prompt delivery of more effective and safer products to patients and medical facilities, while taking into account the risk-benefit ratio. In recent years, PMDA has focused on evaluating new modalities such as antisense nucleic acids, siRNA, and CAR-T cells, which are expected to receive marketing approval as soon as possible due to their unique mechanisms of action. However, since these products have limited development experience, their safety in humans must be carefully evaluated.
Based on PMDA's experience in regulatory strategy consultation, clinical trial consultation, and regulatory submission, this presentation will discuss the concept of non-clinical safety studies for various new modalities and aim to deepen mutual understanding on non-clinical safety evaluation of these modalities.
