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W-12: FDA Inspections in Japan: A Comparison with PMDA inspections





Poster Presenter

      Eunhee Chung

      • Director
      • SOUSEIKAI Global Clinical Research Center
        Japan

Objectives

Sharing information regarding a recent BE inspection conducted at SOUSEIKAI Sumida Hospital in Japan by the US FDA in January 2017. In this research, we also reviewed past FDA inspections that were conducted in Japan, and compared the characteristics of these inspections with the PMDA inspections.

Method

To date,16 inspections were conducted in Japan from the US FDA, including 2 Inspections for 3 protocols at SOUSEIKAI Sumida Hospital. For a better understanding of the purposes of the FDA and PMDA inspections, we reviewed the process and the results from the inspections conducted from 1988 to 2017.

Results

According to the FDA database 3,962 inspections for the project 48 Bioresearch Monitoring (BIMO) from the Center for Drug Evaluation and Research have been conducted in the world from Jan. 2008 to present. Among these inspections, 16 inspections were conducted in Japan, including 2 inspections at SOUSEIKAI; the first inspection was done in 2008, and the second was conducted in 2017. Besides these two FDA inspections, SOUSEIKAI has had 47 inspections from the Japanese regulatory authority, the PMDA. Based on our inspection experiences and the publicly available information related to inspections at other sites, we found differences in the methods, processes, and resulting evaluations over the entire process of inspections between the PMDA and the US FDA. We found that even though there are some differences in the inspections from these two regulatory, by preparing accordingly for the inspection based on our past experiences and attention to common patterns of questions, documentation queries, and staff availability, we were able to make the process an increasingly more smooth, transparent, and overall effective and efficient one.

Conclusion

As the globalization of drug development has been increasing both extensively and steadily, the inspections themselves are also becoming widely globalized as well. There are few differences in the GCPs and regulations in Japan, however the purpose of inspections are usually the same as other countries: protect the rights and safety of human research subjects, and assure the quality and integrity of research data. By understanding the purpose of the inspections, discerning and learning from the similarities and differences between inspections with global perspectives and implications, it will be possible to continue to create a global standard for conducting clinical trials that will eventually lead to deliverance of new medicines to patients all over the world more safely and quickly. Through our experience handling a broad variety of global trials, with all the related inspections and challenges that come with them, this enables us to have the skill and insight to carry out future trials even more efficiently, raising the bar of global standards for safer and even more effective clinical research and trials.