Among other things, the agency is tasked with the following: • Drug and medical device testing: • Scientific review of market authorization applications based on Japanese pharmaceutical law • Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA)) • Inspection and conformity assessment of
Good Clinical Practice (GCP),
Good Laboratory Practice (GLP), and
Good Practice Systems and Programs (GPSP) • Auditing of manufacturers to ensure they conform to
Good Manufacturing Practice (GMP) and have a suitable
Quality Management System (QMS) • Post-marketing drug safety: • The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices • Advising consumers on approved products • Research on the development of industry standards • Victim compensation: • Payment of medical costs, lost wages, and pain and suffering for those who experience injury or disability resulting from the use of medical products • Disbursement of funds to those infected with
HIV as a result of
blood transfusions == Leadership ==