What We Do

Drug and Medical Device Reviews

  • Scientific reviews of pharmaceuticals and medical devices for marketing authorization based on the Pharmaceutical Affairs Law of Japan
  • Consultation (Planning and implementation of clinical trials and preparation of NDA dossiers, etc.)
  • GCP / GLP / GPSP inspections and conformity audit on dossiers submitted as initial application, re-examination and re-evaluation application
  • GMP / QMS inspections on manufacturing sites, processes and quality management system of pharmaceuticals and medical devices
  • Confirmation of re-examination and re-evaluations based on the Pharmaceutical Affairs Law

Post-marketing Safety

  • Collection, analysis and dissemination of information related to the quality, efficacy and safety of pharmaceuticals and medical devices
  • Consultation services for consumers about safe use of pharmaceuticals and medical devices
  • Advice and instruction for marketing authorization holders to enhance safety of pharmaceuticals and medical devices
  • Research relating to the development of standards for pharmaceuticals and medical devices

Relief Services for Adverse Health Effects

  • Providing medical expenses, disability pensions, bereaved family pensions, etc. for people who have suffered from severe illness and disabilities caused by adverse drug reactions of pharmaceuticals or infections from biological products
  • Providing healthcare allowances, etc. to SMON (subacute myelo-optico-neuropathy) patients and commissioned benefits services to HIV-positive and AIDS patients infected by blood products
  • Providing compensations in accordance with "the Special Measures Law concerning the Payment of Benefits to Relieve the Patients of Hepatitis C Infected through Specified Fibrinogen Preparations and Specified Blood-Coagulation Factor IX Preparations Contaminated by Hepatitis C Virus"

International Programs

  • Implementation of PMDA International Strategic Plan through international regulatory harmonization, bilateral relationship, effective communication with relevant external parties, etc.