• Add this page to "Favorite pages"
  • Print the text(Open link in a new browser window)
Here begins the text.

GLP / GCP / GPSP Compliance Assessments

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 appropr iate way in compl iance 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.
PMDA also provides GLP compliance certification to testing laboratories.

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

  • Contact us
  • Access/Map

Copyright (C) Pharmaceuticals and Medical Devices Agency, All Rights Reserved.

000041645
0
GLP / GCP / GPSP Compliance Assessments
/english/review-services/glp-gcp-gpsp/0001.html
en