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The Pharmaceuticals and Medical Devices Agency Annual Report Fy 2010 Table of Contents

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THE PHARMACEUTICALS AND MEDICAL DEVICES AGENCY ANNUAL REPORT FY 2010 TABLE OF CONTENTS Page I. THE PHARMACEUTICALS AND MEDICAL DEVICES AGENCY .................. 1 PART 1 History and Objective of PMDA ........................................................................................................ 2 PART 2 Outline of Operations ........................................................................................................................ 4 2.1 Relief Services for Adverse Health Effects ............................................................................... 4 2.2 Reviews ..................................................................................................................................... 4 2.3 Safety Measures ....................................................................................................................... 5 II. OPERATING PERFORMANCE FOR FY 2010............................................... 7 PART 1 Development of Fiscal Year 2010 Plan ............................................................................................ 8 1.1.Development and Implementation of Fiscal Year 2010 Plan ................................................... 8 1.2.Results of the Evaluation on Operating Performance for FY 2009 .......................................... 8 1.3.Budget Screening by the Government Revitalization Unit ..................................................... 11 PART 2 Improvement in Overall Management of Operations and Service Quality of PMDA ..................... 14 2. 1.Efficient and Flexible Management of Operations .................................................................. 14 2.1.(1) Operation through target management .................................................................... 14 2.1.(2) Reinforcement of operational management system and top-down management ... 14 2.1.(3) Advisory Council meetings ....................................................................................... 17 2.1.(4) Approaches for an efficient operation system .......................................................... 19 2.1.(5) Standardization of operating procedures ................................................................. 19 2.1.(6) Development of databases....................................................................................... 20 2.1.(7) Promotion of the optimization of operations and systems ....................................... 20 2.2.Cost Control through Increased Efficiency of Operations ...................................................... 20 2.2.(1) Retrenchment of general administrative expense ................................................... 20 2.2.(2) Cost control of operating expenses.......................................................................... 21 2.2.(3) Competitive bidding .................................................................................................. 22 2.2.(4) Contract Review Committee meetings ..................................................................... 22 2.2.(5) Collection and management of contributions ........................................................... 22 (i) Collected contributions for adverse drug reaction fund and trends in the liability reserve .................................................................................................. 24 a. Adverse drug reaction fund ....................................................................... 24 b. Collected contributions for relief for infections acquired through biological products ..................................................................................... 24 c. Liability reserve .......................................................................................... 25 (ii) Collected contributions for post-marketing safety measures ........................... 25 2.2.(6) Reduction in personnel expenses, etc. .................................................................... 26 2.2.(7) Promotion of measures for reduction of unnecessary expenditures ....................... 26 2.3.Improvement of Services to the Public ................................................................................... 27 2.3.(1) General consultation service .................................................................................... 27 2.3.(2) Responses to consultations, complaints, and claims of dissatisfaction from companies regarding reviews and post-marketing safety operations ..................... 27 2.3.(3) Improvement in the PMDA website .......................................................................... 28 2.3.(4) Proactive PR activities .............................................................................................. 29 2.3.(5) Disclosure request for corporate documents ........................................................... 29 2.3.(6) Disclosure request for personal information ............................................................ 31 2.3.(7) Auditing and related matters .................................................................................... 32 2.3.(8) Report on the financial standing ............................................................................... 32 2.3.(9) Official announcement of the Plan for the Review of Optional Contracts, etc. ........ 32 2.4.Personnel Issues ..................................................................................................................... 32 2.4.(1) Personnel evaluation system ................................................................................... 32 2.4.(2) Systematic implementation of staff training ............................................................. 32 2.4.(3) Appropriate personnel allocation .............................................................................. 34 2.4.(4) Securing of human resources through open recruitment ........................................ 35 2.4.(5) Appropriate personnel management based on work regulations ............................ 37 2.5.Ensuring Security .................................................................................................................... 37 2.5.(1) Entry/exit access control .......................................................................................... 37 2.4.(2) Security measures for information systems ............................................................. 38 PART 3 Improvement in Management of Operations and Quality of Services in Each Division ................ 39 3.1 Relief Fund Services ............................................................................................................... 39 3.1.(1) Expansion and reconsideration of the provision of information ............................... 39 (i) Online disclosure of cases of payment of benefits ........................................... 39 (ii) Improvement of brochures, etc. ........................................................................ 39 3.1.(2) Proactive PR activities .............................................................................................. 40 3.1.(3) Efficient management of the consultation service ................................................... 44 3.1.(4) Integrated management of information through databases ..................................... 45 3.1.(5) Prompt processing of relief benefit claims ............................................................... 46 (i) Relief Service for Adverse Drug Reactions ...................................................... 47 a. Actual performance of Relief Service for Adverse Drug Reactions .......... 47 b. Number of claims by type of benefit .......................................................... 48 c. Judgment status by type of benefit ............................................................ 48 (ii) Relief Service for Infections Acquired through Biological Products ................. 49 a. Actual performance of relief for infections ................................................. 49 b. Number of claims by type of benefit .......................................................... 49 c. Judgment status by type of benefit ............................................................... 50 3.1.(6) Promotion of appropriate communication of information through collaboration between operational divisions .................................................................................. 50 3.1.(7) Appropriate implementation of health and welfare services .................................... 50 3.1.(8) Appropriate implementation of healthcare allowances for SMON patients and HIV-positive patients affected through blood products ............................................ 52 (i) Services for SMON patients (commissioned payment of healthcare allowances) ....................................................................................................... 52 (ii) AIDS-related services (commissioned payment of healthcare allowances) .... 53 3.1.(9) Appropriate Implementation of the payment of benefits to assist individuals affected by hepatitis C through specified fibrinogen products and specified blood coagulation factor IX products contaminated by hepatitis C virus ................. 54 3.2 Reviews and Related Services and Safety Measures Services ............................................. 55 3.2.(1) Faster Access to the Latest Drugs and Medical Devices ........................................ 55 New drugs ........................................................................................................................
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