[SHINSA]The English versions of GMPGCTP Annual Report FY 2025 have been published.

The Office of Manufacturing Quality for Drugs (OMQD), publishes the GMP/GCTP Annual Report, presenting its activities and achievements related to GMP inspection, the regulatory framework, international initiatives, current issues, and future perspectives.

In addition to the main body of the report, the FY 2023, FY 2024 and FY 2025 reports are accompanied by a “List of Identified Deficiencies”, which outlines the major deficiencies observed during GMP inspections conducted by PMDA in each fiscal year. All confidential information is appropriately anonymized.

To Our Readers: We Value Your Feedback
（The survey closed on March 31, 2026. We sincerely appreciate your cooperation.）

The GMP/GCTP Annual Report aims not only to enhance the transparency of PMDA’s activities, but also to promote mutual understanding between PMDA and pharmaceutical companies/regulatory authorities both in Japan and overseas.
In order to better tailor the content of the Report to the needs of our readers, we would greatly appreciate it if you could share your feedback through this questionnaire.

The questionnaire can be accessed via the URL or QR code provided below.
The deadline for responses is scheduled for March 31, 2027.

https://app.sli.do/event/sTX5twiPJhUjMmbMXsKgq1

Publication of Inspectional observations

 From fiscal year 2022, PMDA started publishing GMP observations for which dissemination is considered particularly useful as warning and technical reference for the industry. The purpose of the publication is to promote voluntary efforts for quality improvements in pharmaceutical manufactures.

List of Rapid announcement of Inspectional observations

Observed Regulatory Attention / Notification of GMP Elements (Orange Letters)