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Trends in the Development of Products in Japan and Differences Between ICH-GCP and J-GCP

In Japan, clinical trials must be conducted under the unique Japan-Good Clinical Practice (J-GCP) process—while compatible with the International Council for Harmonisation Good Clinical Practice (ICH-GCP), the processes differ in some key areas.

In this white paper, Syneos Health experts examine the required documentation and the differences between ICH-GCP and J-GCP. At the same time, they look at how this has impacted trends in the development of pharmaceuticals, medical devices and regenerative medical products in Japan, including the approval of behavior change applications and the status of decentralized clinical trials.

Download the white paper.

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