Outline of Reviews and Related Services

During the review process, PMDA evaluates the quality,efficacy, and safety of drugs, medical devices, and cellular and tissue-based products in light of current scientific and technological standards. In addition, PMDA’s reviews and related services consist of various activities, such as “consultations” providing advice in relation to regulatory submission, GLP/GCP/GPSP inspections to ensure the submitted data are in compliance with the ethical and scientific standards, and GMP/QMS/GCTP inspections to ensure quality management of the manufacturing facility for the product submitted for approval.