Due to Pandemic, Japan Extends Permission to Conduct GCP Compliance Inspections Remotely

Seeking to ensure clinical trials are accurate, credible, and safe while protecting the health of its personnel during the COVID-19 pandemic, Japanese regulators will continue to conduct Good Clinical Practice (GCP) inspections remotely through April 1, 2021.

The announcement by Japan’s Pharmaceutical and Medical Devices Agency (PMDA) allows the sites of companies operating in the country to be examined remotely after documentation is submitted to inspectors in advance. Remote inspections were first instituted earlier this year due to the constraints of the pandemic. Previously, the PMDA required on-site inspections.