In September 2023, the Pharmaceutical Safety and Environmental Health Bureau (PSEHB) had an organization name change to the Pharmaceutical Safety Bureau (PSB). Divisions responsible for food regulations under PSEHB have been transferred to the Health Service Bureau within the Ministry of Health, Labour and Welfare.

PSB is the legal successor to the Pharmaceutical and Food Safety Bureau (PFSB) as the competent authority responsible for the regulation of drugs and medical devices. PSB commits to implementing the 2004 Confidentiality Commitment Statement of Legal Authority and Commitment between FDA and the former PFSB as written and will continue to protect FDA-provided non-public information provided previously or in the future under the 2004 Confidentiality Commitment Statement of Legal Authority and Commitment.

 

In April 2015, the Pharmaceutical and Food Safety Bureau (PFSB) had an organization name change to the Pharmaceutical Safety and Environmental Health Bureau (PSEHB) in April 2015. The legal role, functions and responsibilities of PFSB remain the same under PSEHB.

PSEHB commits to implementing the 2004 Confidentiality Commitment Statement of Legal Authority and Commitment between FDA and the former PFSB as written, and will continue to protect FDA-provided non-public information provided previously or in the future under the 2004 Confidentiality Commitment Statement of Legal Authority and Commitment.