PMDA

This article is about the Japanese authority. For the arms control treaty see Plutonium Management and Disposition Agreement .

The PMDA ( Japanese (独立 行政 法人) 医 薬 品 医療 機器 総 合 機構 , (dokuritsu gyōsei hōjin) iyakuhin iryōkiki sōgō kikō ; English: Pharmaceuticals and Medical Devices Agency , abbreviated PMDA) is the Japanese authority for drugs and medical devices . She works with the Japanese Ministry of Health, Labor and Social Affairs (MHLW). The PMDA is active in areas of approval (scientific evaluation of applications for marketing authorizations for medicinal products and medical devices), the monitoring of drug and medical device manufacturers ( good manufacturing practice , good laboratory practice , quality management ), the advice regarding clinical trials , as well as monitoring the safety of medicines and medical devices after market approval ( pharmacovigilance , vigilance system ). In addition, the agency maintains an aid organization for patients who have been harmed by drug side effects or other undesirable side effects of therapy with drugs or medical products.

The agency was formed on April 1, 2004 from a merger of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR / KIKO) and parts of the Japan Association for the Advancement of Medical Equipment (JAAME) founded.

tasks

• Drug and medical device testing:
  • Scientific review of marketing authorization applications based on Japanese pharmaceutical law
  • Advice z. B. in the area of ​​clinical studies or the preparation of dossiers for the approval process ( New Drug Applications (NDA) dossier)
  • Inspections and conformity assessment for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Practice Systems and Programs (GPSP)
  • Audits at producers on Good Manufacturing Practice (GMP) and Quality Management System (QMS)
  • Approval after review and evaluation based on pharmaceutical law.
• Drug safety after market approval:
  • The collection, evaluation and information of quality, efficacy and safety data of drugs and medical devices.
  • Advice to consumers on approved products.
  • Help desk for the marketing authorization holder ( Marketing Authorization Holders to safety aspects related to improved (MAH)) to the products.
  • Research into the development of industry standards
• Compensation for injured parties:
  • Payment of medical costs incurred, pensions in the event of disabilities or compensation for family members who have incurred through medical products.
  • Payment of health subsidies for subacute myelo-optico-neuropathy patients or commissioning of aid programs for HIV- infected patients who have been infected by blood transfusions .
  • Compensation payments for people infected with hepatitis C due to fibrinogen treatment or treatment for blood clotting with factor IX due to hepatitis C virus contamination.

Web links

• Official website (Japanese, English)