Update on Japan Regulatory Agency
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.