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* * * * * * * * * * * Thank you very much for your kind attention. 2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China 2nd DIA China Annual Meeting | May 16-19, 2010 | Beijing, China Pharmacovigilance in Japan. －Overview Specific drug safety issue－ Tomoko Okudaira 　 Office of Safety Ⅱ,Office of New DrugⅤ Pharmaceuticals Medical Devices Agency （PMDA）,JAPAN　 Disclaimer Translation note English and Japanese are not a perfect match The contents of this presentation represent the view of the speaker only and do not necessarily represent the official positions or policies of the PMDA Today’s Topic Organization of PMDA Pillars Cooperation with Ministry of Health, Labour and Welfare (MHLW) Post-marketing activities in Japan GVP ADR report EPPV Re-examination Current situation of PhV plan Risk Management Risk Management Option in Japan New Risk Management System in Japan PMDA’s Three Work Areas Relief Service for SMON, HIV-positive, AIDS and Hepatitis C patients Relief Service for ADR and Other Infectious Disease Review and Audit for Drugs/ Medical Devices Efficacy and Safety Provision of Medical Expenses, Disability Pensions etc. Clinical Trial Consultation Conformity Audit for Application Materials of GLP,GCP and GMP Information Provision (via the Internet), Pharmaceutical Consultation for Consumers Post-marketing Safety Operations for Drugs/ Medical Devices Review of Efficacy and Safety Reinforced Safety Information (Database) Scientific Review and Research for Safety Information Pharmacovigilance Operation Flowchart- MHLW/PMDA Cooperation - Receipt of ADR/ Infection Reports Planning for Safety Measure Information Provision System （via the Internet） Safety Measure Implementation DATA　BASE MHLW PMDA Real-time Notification Scientific/ Objective Research Analysis of Accumulative Information 　　　　?Expert Consultation 　　　　?Company interviews Extracting Urgent Significant Info. Keep Tracking Information Compiling Reports Advisory committe