PMDA conducts inspections and data integrity assessments in relation to applications for marketing approval, re-examination, re-evaluation, or use-results evaluation of a product to assess whether the tests and clinical trials have been conducted in an ethically and scientifically appropriate way in compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Post-Marketing Surveillance Practice (GPMSP) or Good Post-marketing Study Practice (GPSP), and whether the submitted data comply with the data integrity standards for regulatory submission documentation.
Regulatory Information on GLP.