Pharmaceuticals and Medical Devices Agency

Tasks

• 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
• * Inspection and conformity assessment of Good Clinical Practice, Good Laboratory Practice, and Good Practice Systems and Programs
• * Auditing of manufacturers to ensure they conform to Good Manufacturing Practice and have a suitable Quality Management System
• 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 suffer 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