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The Pharmaceuticals and Medical Devices Agency THE PHARMACEUTICALS AND MEDICAL DEVICES AGENCY ANNUAL REPORT FY 2009 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 2009 ............................................... 7 PART 1 Development of Fiscal Year 2009 Plan .......................................................................................... 8 1.1 Development and Implementation of Fiscal Year 2009 Plan .................................................. 8 1.2 Results of the Evaluation on Operating Performance for FY 2008 and Results of the Final Evaluation on Operating Performance during the Effective Period of the Mid-term Targets ................................................................................................................................................ 8 PART 2 Improvement in Overall Management of Operations and Service Quality of PMDA .................... 12 2.1 Efficient and Flexible Management of Operations ................................................................ 12 2.1.(1) Operation through target management .................................................................. 12 2.1.(2) Reinforcement of operational management system and top-down management ... 12 2.1.(3) Advisory Council meetings ..................................................................................... 15 2.1.(4) Approaches for an efficient operation system ........................................................ 16 2.1.(5) Standardization of operating procedures ................................................................ 17 2.1.(6) Development of databases ..................................................................................... 17 2.1.(7) Promotion of the optimization of operations and systems ...................................... 18 2.2 Cost Control through Increased Efficiency of Operations ..................................................... 18 2.2.(1) Retrenchment of general administrative expenses ................................................ 18 2.2.(2) Cost control of operating expenses ........................................................................ 19 2.2.(3) Competitive bidding ................................................................................................ 19 2.2.(4) Collection and management of contributions ......................................................... 20 (i) Collected contributions for adverse drug reaction fund and trends in the liability reserve ................................................................................................ 21 (ii) Collected contributions for post-marketing safety measures ........................... 23 2.2.(5) Reduction in personnel expenses and overhaul of the remuneration system ........ 23 2.2.(6) Promotion of measures for reduction of unnecessary expenditures ....................... 24 2.3 Improvement of Services to the Public ................................................................................. 24 2.3.(1) General consultation service .................................................................................. 24 2.3.(2) Responses to consultations, complaints, and claims of dissatisfaction from companies regarding reviews and post-marketing safety operations ..................... 24 2.3.(3) Improvement in the PMDA website ........................................................................ 25 2.3.(4) Proactive PR activities ............................................................................................ 25 2.3.(5) Disclosure request for corporate documents .......................................................... 25 2.3.(6) Disclosure request for personal information ........................................................... 26 2.3.(7) Auditing and related matters .................................................................................. 27 2.3.(8) Report on the financial standing ............................................................................. 27 2.3.(9) Official announcement of the Plan for the Review of Optional Contracts ............... 28 2.4 Personnel Issues .................................................................................................................. 28 2.4.(1) Review of personnel evaluation system ................................................................. 28 2.4.(2) Systematic implementation of staff training ............................................................ 28 2.4.(3) Appropriate personnel allocation ............................................................................ 29 2.4.(4) Securing of human resources through open recruitment ........................................ 30 2.4.(5) Appropriate personnel management based on work regulations .......................... 32 2.5 Ensuring Security .................................................................................................................. 32 2.5.(1) Entrance/exit access control .................................................................................. 32 2.5.(2) Security measures for information systems ............................................................ 33 PART 3 Improvement in Management of Operations and Quality of Services in Each Division ................ 34 3.1 Relief Fund Services ............................................................................................................. 34 3.1.(1) Expansion and reconsideration of the provision of information .............................. 34 (i) Online disclosure of cases of payment of benefits .......................................... 34 (ii) Improvement of brochures, etc. ...................................................................... 34 3.1.(2) Proactive PR activities ............................................................................................ 34 3.1.(3) Management of the consultation service ................................................................ 37 3.1.(4) Central management of information through databases......................................... 38 3.1.(5) Prompt processing of relief benefit claims .............................................................. 38 (i) Relief Service for Adverse Drug Reactions ..................................................... 40 a. Actual performance of Relief Service for Adverse Drug Reactions .......... 40 b. Number of claims by type of benefit ......................................................... 40 c. Judgment status by type of benefit .......................................................... 41 (ii) Relief Service for Infections Acquired through Biological Products ................. 41 a. Actual performance of relief for infections ................................................ 42 b. Number of claims by type of benefit ......................................................... 42 c. Judgment status by type of benefit .......................................................... 42 3.1.(6) Promotion of appropriate communication of information through collaboration between operational divisions ................................................................................ 43 3.1.(7) Surveys on actual state of health damage caused by adverse drug reactions (investigative research as part of health and welfare services) .............................. 43 3.1.(8) Appropriate implementation of healthcare allowances for SMON patients and HIV-positive patients affected through blood products ........................................... 44 (i) Services for SMON patients (commissioned payment of healthcare allowances) ..................................................................................................... 44 (ii) AIDS-related services (commissioned payment of healthcare allowances) .... 45 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 ................ 46 3.2 Reviews and Related Services and Safety Measures Services ............................................ 47 3.2.(1) Faster Access to the Latest Drugs and Medical Devices ....................................... 47 New drugs ....................................................................................................................... 47 (i) Implementation of appropriate and prompt reviews ........................................ 47 a. Implementation structure for clinical trial consultations and reviews ........ 47 b. Reinforcement and improvement in the transparency of the progress management of reviews ........................................................................... 51 c. Standardization of review......................................................................... 52 d. Implementation
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