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Regulation & Policy

Pharmaceutical Regulatory Industry


Publication Date   January 2006
Publisher   Business Communications Company
Product Type   Report
Pages   156
ISBN Number   not applicable
Product Code   BCC026
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Summary


Since Congress enacted the Pure Food and Drugs Act of 1906, the regulatory agency spawned by this law, the U.S. Food and Drug Administration (FDA), has come to directly regulate between one-fifth and one-quarter of U.S. gross domestic product (GDP). It possesses significant power over product entry, the ways in which food and drugs are marketed to consumers, and the manufacturing practices of food and drug firms.

Drug regulatory agencies play a key role in ensuring that medicines available for use are safe and effective. Recent efforts to improve access to medicines in the developing world have led to a focus not only on prices and international barriers to trade, but on national drug regulatory agencies (DRAs) and their role in registering drugs for use.

This comprehensive report covers current and potential aspects of the regulatory industry in the pharmaceutical . It provides a complete analysis of the new drugs being approved, the recalls/withdrawals experienced by the pharmaceutical industry, and spending in the regulatory sector.

The study explores the past, present and future strategies and policies used in regulatory compliance for drug development and postmarketing issues. Also included are product forecasts for new drugs and recalls, as well as the regulations, types of regulatory agencies and the approval process for drug products.

Scope Of Study

The report contains:

  • Coverage of regulatory environments worldwide
  • Analyses of each market by drug category
  • Discussions of the process and time involved in approval - NDA, BLA, EMEA
  • Postmarketing issues
  • Market trends with historical perspectives
  • Five-year market projections for new approvals and recalls
  • Drug safety spending data
  • Company profiles.

Report Highlights

  • The total number of new drugs approved by the FDA and EMEA dropped to 121 in 2005. Approvals will increase to 201 by 2010, at an AAGR of 10.7%.
  • There were about 1,934 recalls in 2003 (including all batch recalls and product recalls), and the rate increased to 2,072 in 2005. It is expected to increase at an AAGR of 5.1% to reach 2,616 by 2010.
  • The most recalls in 2005 were seen in pain management, anti-inflammatory, anesthetics and antiallergic drugs.
  • Spending in the regulatory and surveillance industry is expected to rise at an AAGR of 10% to reach $265 billion by 2010, with the emphasis on oncology, cardiovascular, hormonal, contraceptive and mental disorder drug markets.

Content


  • Introduction
    • Study Objectives
    • Reasons For Doing This Study
    • Contributions Of The Study And For Whom
    • Scope And Format
    • Methodology
    • Information Sources
    • Analyst's Credentials
    • Related BCC Reports
    • BCC Online Services
    • Disclaimer
  • Summary
    • Summary Table: Forecast Of Approvals And Recalls In The U.S. And Europe By Fda And Emea, Through 2010 (UNITS)
    • Summary Figure: Total Approvals And Recalls By Fda And Emea, 2003-2010 (UNITS)
  • Overview
    • Background
    • History
    • Need For Regulatory Authorities
    • New Regulations
  • Types Of Drug Regulatory Authorities In The World
    • United States
      • Fda (Food & Drug Administration)
      • Dea (Drug Enforcement Administration)
      • Osha (Occupational Safety And Health Administration)
    • Europe
      • Emea (European Medicines Agency)
      • Heads Of Agencies
    • Belgium
      • Directorate-General Medicinal Products (DGMP)
    • Czech Republic
      • State Institute For Drug Control
    • Denmark
      • Danish Medicines Agency
    • Estonia
      • State Agency Of Medicines
    • Finland
      • National Agency For Medicines (NAM)
    • France
      • Agence Du Medicament
    • Germany
      • Bundesinstitut Für Arzneimittel Und Medizinprodukte (BFARM)
      • Paul-Ehrlich Institut
    • Netherlands
      • The Medicines Evaluation Board (MEB) And The Meb Agency
    • Norway
      • Norwegian Medicines Agency (NOMA)
    • Portugal
      • National Institute Of Pharmacy And Medicines (INFARMED)
    • Sweden
      • Medical Products Agency (MPA)
    • Switzerland
      • Swissmedic
    • Uk
      • Medicines And Healthcare Products Regulatory Agency (MHRA)
    • Australia
      • Therapeutic Goods Administration (TGA)
    • New Zealand
      • Medsafe
      • Pharmaceutical Management Agency (PHARMAC)
    • Japan
      • Pharmaceutical And Medical Safety Bureau
    • Others
      • International Conference For Harmonization (ICH)
      • World Health Organization (WHO)
  • Types Of Regulations Governed
    • Non-Clinical
    • Clinical
    • Manufacturing
    • Marketing
  • The Approval System
    • United States
    • Europe
      • The Centralized Procedure
      • Mutual Recognition
      • The National Procedure
    • Australia
  • Investigational New Drugs
    • Investigational New Drugs
    • Inds Categorized By The Trial Phase
  • The New Drug Application (NDA) And The Biologic Liscence Application (BLA)
    • Categories Of Ndas By Their Filing Status
      • New Molecular Entity
      • New Ester, New Salt, Or Other Non-Covalent Derivative
      • New Formulation
      • New Combination
      • New Manufacturer
    • Ndas Categorized By Indications
      • Respiratory Drugs
      • Cardiovascular Drugs
      • Pain Management, Anesthetics And Anti-Inflammatory Drugs
      • Autocoids (Anti-Allergics)
      • Drugs Used In Mental Disorders
      • Urological Disorders
      • Hormones, Contraceptives, Women's Health Products
      • Gastrointestinal (GIT) Drugs
      • Anti-Microbial Drugs
      • Drugs Used In Oncology
      • Immunosuppressants
      • Ophthalmology
      • Diagnostics
      • Miscellaneous Drugs
    • Ndas Categorized By The Review Time
  • Products Approved By Emea
    • Centrally Authorized Medicinal Products Categorized By Indications
      • Cardiovascular Drugs
      • Pain Management, Anesthetics And Anti-Inflammatory Drugs
      • Drugs Used In Mental Disorder
      • Drugs For Urological Disorders
      • Hormones, Contraceptives, Women's Health Products
      • Blood Disorders Drugs
      • Orthopaedic Drugs
      • Drugs Used In Oncology
      • Immunosuppressants
      • Diagnostics
      • Miscellaneous Drugs
    • Approval Time By Emea
  • Postmarketing Issues
    • Drug Safety And Surveillance
      • United States
      • Europe
      • Australia
      • Cardiovascular Drugs
      • Pain Management, Anesthetics And Anti-Inflammatory Drugs
      • Mental Disorder Drugs
      • Urological Disorder Drugs
      • Hormones, Contraceptives And Women's Health Products
      • Drugs Used To Treat Blood Disorders
      • Orthopedic Drugs
      • Oncology Drugs
      • Immunosupressant Drugs
      • Drugs Used In Allergies
      • Git Drugs
      • Respiratory Drugs
      • Antibiotics, Anti-Fungal, And Anti-Malarial Drugs
      • Miscellaneous Drugs
    • Recalls/ Withdrawls
      • Fda
        • Cardiovascular Drugs
        • Mental Disorder Drugs
        • Urological Disorder Drugs
        • Hormones, Contraceptives And Women's Health Products
        • Drugs Used To Treat Blood Disorders
        • Oncology Drugs
        • Immunosupressant Drugs
        • Respiratory Drugs
        • Git Drugs
        • Antibiotics, Anti-Fungals And Anti-Malarials
        • Pain Management, Anesthetics, Anti-Allergics And Anti-Inflammatory Drugs
        • Diagnostics
        • Miscellaneous Drugs
        • Biologicals And Devices
      • Emea
      • Tga
  • Drug Safety Spending
    • Drug Safety Spending
  • Company Profiles
    • Abbott Laboratories
    • Alliant Pharmaceuticals
    • Bristol-Myers Squibb
    • Celegene
    • Celltech Pharmaceuticals
    • Eli Lilly
    • Glaxosmithkline Plc
    • Johnson & Johnson
      • Advanced Sterilization Products
      • Alza Corporation
      • Babycenter, L.L.C.
      • Centocor, Inc.
      • Global Biologics Supply Chain, Llc
      • Cordis Corporation
      • Biosense Webster, Inc.
      • Depuy, Inc.
      • Codman & Shurtleff, Inc.
      • Ejnj, Llc
      • Ethicon, Inc.
      • Johnson & Johnson Wound Management
      • Ethicon Endo-Surgery, Inc.
      • Independence Technology, L.L.C.
      • Janssen Pharmaceutica Products, L.P.
      • Johnson & Johnson Consumer Products Company
      • Johnson & Johnson Development Corporation
      • Johnson & Johnson Gateway, Llc
      • Johnson & Johnson Health Care Systems Inc.
      • Johnson & Johnsonmerck Consumer Pharmaceuticals Co.
      • Johnson & Johnson Networking & Computing Services
      • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
      • Johnson & Johnson Sales And Logistics Company
      • Johnson & Johnson Vision Care, Inc.
      • Lifescan, Inc.
      • Mcneil Consumer & Specialty Pharmaceuticals
      • Mcneil Nutritionals
      • Neutrogena Corporation
      • Noramco, Inc.
      • Ortho Biotech Products, L.P.
      • Ortho-Clinical Diagnostics, Inc.
      • Ortho-Mcneil Pharmaceutical, Inc.
      • Scios Inc.
      • Therakos, Inc.
      • Veridex, Llc
    • Mallinckrodt Medical
    • Mds Pharma Services
    • Novartis Pharmaceutical Corp.
      • Novartis International Ag
    • Pfizer, Inc.
    • Roche
    • Shire
  • Appendix
    • Acronyms
  • List Of Figures
    • Summary Table: Forecast Of Approvals And Recalls In The U.S. And Europe By Fda And Emea, Through 2010 (UNITS)
    • Table 1 History Of Pharmaceutical And Food Regulatory Industry
    • Table 2 New Regulations, 2003-2005
    • Table 3 Pharmaceutical Regulatory Agencies Around The World
    • Table 4 Warning Letters Issues By The Fda For Non-Compliance Inglp, 2001-2005
    • Table 5 Warning Letters Issues By The Fda For Non-Compliance In Gcp, 2001-2005
    • Table 6 Warning Letter Issues By The Fda For Non-Compliance In Gmp, 2001-2005
    • Table 7 Warning Letter Issues By The Fda For Non-Compliance In Marketing, 2001-2005
    • Table 8 Warning Letter Issues By The Fda For Non-Compliance In Glp, Gcp, Gmp And Marketing, 2001-2005 (%)
    • Table 9 Forecast Of North American Active Inds Approved By Fda, Through 2010 (UNITS)
    • Table 10 Forecast Of North American Inds Approved By The Fda Existing In Different Phases Of Clinical Trials, Through 2010 (UNITS)
    • Table 11 Forecast Of North American Ndas Approved By The Fda, Categorized By New Molecular Entity, Through 2010 (UNITS)
    • Table 12 Forecast Of North American Ndas Approved By The Fda, Categorized By New Ester, New Salt, Or Other Noncovalent Derivative, Through 2010 (UNITS)
    • Table 13 Forecast Of North American Ndas Approved By The Fda, Categorized By New Formulation, Through 2010 (UNITS)
    • Table 14 Forecast Of North American Ndas Approved By The Fda, Categorized By New Combination, Through 2010
    • Table 15 Forecast Of North American Ndas Approved By The Fda, Categorized By New Manufacturer, Through 2010 (UNITS)
    • Table 16 Ndas Approved By The Fda, For Respiratory Problems, Through 2010 (UNITS)
    • Table 17 Forecast Of North American Ndas Approved By The Fda For Cardiac Problems, Through 2010 (UNITS)
    • Table 18 Forecast For North American Ndas Approved By The Fda, For Pain Management, Anesthetics And Anti-Inflammatory Problems, Through 2010 (UNITS)
    • Table 19 Forecast For North American Ndas Approved By The Fda For Allergies, Through 2010 (UNITS)
    • Table 20 Forecast For North American Ndas Approved By The Fda For Mental Disorders, Through 2010 (UNITS)
    • Table 21 Forecast For North American Ndas Approved By The Fda, For Urological Disorders, Through 2010 (UNITS)
    • Table 22 Forecast For North American Ndas Approved By The Fda, For Hormones, Contraceptives And Women's Health Products, Through 2010 (UNITS)
    • Table 23 Forecast For North American Ndas Approved By The Fda, For Git Problems, Through 2010 (UNITS)
    • Table 24 Forecast For North American Ndas Approved By The Fda, For Anti-Microbial Agents, Through 2010 (UNITS)
    • Table 25 Forecast For North American Ndas Approved By The Fda, For Oncological Problems, Through 2010 (UNITS)
    • Table 26 Forecast For North American Ndas Approved By The Fda, For Immunosuppressant Drugs, Through 2010 (UNITS)
    • Table 27 Forecast For North American Ndas Approved By The Fda, For Ophthalmic Problems, Through 2010 (UNITS)
    • Table 28 Forecast For North American Ndas Approved By The Fda, For Diagnostics, Through 2010 (UNITS)
    • Table 29 Forecast For North American Ndas Approved By The Fda, For Miscellaneous Drugs, Through 2010 (UNITS)
    • Table 30 Priority And Standard Approvals By The Fda, 2000-2004
    • Table 31 Priority And Standard Approvals By The Fda For Nmes, 2000-2004
    • Table 32 Forecast For North American Priority And Standard Approvals By The Fda, Through 2010 (UNITS)
    • Table 33 Forecast Of Time Required For Approval Of A Drug By Fda In North America, Through 2010 (MONTHS)
    • Table 34 Forecast Of European Products Approved By The Emea, For Cardiac Problems, Through 2010 (UNITS)
    • Table 35 Forecast Of European Products Approved By The Emea, For Pain Management, Anesthetics And Anti-Inflammatory Problems, Through 2010 (UNITS)
    • Table 36 Forecast Of European Products Approved By Emea, For Mental Disorders, Through 2010 (UNITS)
    • Table 37 Forecast Of European Products Approved By The Emea, For Urological Disorders, Through 2010 (UNITS)
    • Table 38 Forecast Of European Products Approved By The Emea, For Hormones, Contraceptives And Women's Health Products Through 2010 (UNITS)
    • Table 39 Forecast Of European Products Approved By The Emea, For Blood Disorders, Through 2010 (UNITS)
    • Table 40 Forecast Of European Products Approved By The Emea, For Orthopedic Problems, Through 2010 (UNITS)
    • Table 41 Forecast Of European Products Approved By The Emea, For Oncological Problems, Through 2010 (UNITS)
    • Table 42 Forecast Of European Products Approved By Emea, For Immunosuppressant Drugs, Through 2010 (UNITS)
    • Table 43 Forecast Of European Products Approved By The Emea For Diagnostics, Through 2010 (UNITS)
    • Table 44 Products Approved By The Emea, For Miscellaneous Drugs, Through 2010 (UNITS)
    • Table 45 Forecast For Approval Time By The Emea Through 2010 (MONTHS)
    • Table 46 Global Forecast Of Drug Label Changes Due To Surveillance For Cardiovascular Drugs, Through 2010 (UNITS)
    • Table 47 Share Of Drug Label Changes Due To Surveillance For Cardiovascular Drugs, 2005 (%)
    • Table 48 Global Forecast Of Drug Label Changes Due To Surveillance For Pain Management, Anesthetics And Anti-Inflammatory Drugs, Through 2010 (UNITS)
    • Table 49 Share Of Drug Label Changes Due To Surveillance For Pain Management, Anesthetics And Anti-Inflammatory Drugs, 2005 (%)
    • Table 50 Global Forecast Of Drug Label Changes Due To Surveillance For Mental Disorder Drugs, Through 2010 (UNITS)
    • Table 51 Share Of Drug Label Changes Due To Surveillance For Mental Disorder Drugs, 2005 (%)
    • Table 52 Global Forecast Of Drug Label Changes Due To Surveillance For Urological Disorders, Through 2010 (UNITS)
    • Table 53 Share Of Drug Label Changes Due To Surveillance For Urological Disorders Drugs, 2005 (%)
    • Table 54 Global Forecast Of Drug Label Changes Due To Surveillance For Hormones, Contraceptives And Women's Health Products, Through 2010 (UNITS)
    • Table 55 Share Of Drug Label Changes Due To Surveillance For Hormones, Contraceptives And Women's Health Products, 2005 (%)
    • Table 56 Global Forecast Of Drug Label Changes Due To Surveillance For Drugs Used To Treat Blood Disorders, Through 2010 (UNITS)
    • Table 57 Share Of Drug Label Changes Due To Surveillance For Drugs Used To Treat Blood Disorders, 2005 (%)
    • Table 58 Global Forecast Of Drug Label Changes Due To Surveillance For Orthopedic Drugs, Through 2010 (UNITS)
    • Table 59 Share Of Drug Label Changes Due To Surveillance For Orthopedic Drugs, 2005 (%)
    • Table 60 Global Forecast Of Drug Label Changes Due To Surveillance For Oncology Drugs, Through 2010 (UNITS)
    • Table 61 Share Of Drug Label Changes Due To Surveillance For Oncology Drugs, 2005 (%)
    • Table 62 Global Forecast Of Drug Label Changes Due To Surveillance For Immunosupressant Drugs, Through 2010 (UNITS)
    • Table 63 Share Of Drug Label Changes Due To Surveillance For Immunosupressant Drugs, 2005 (%)
    • Table 64 Global Forecast Of Drug Label Changes Due To Surveillance For Drugs Used In Allergies, Through 2010 (UNITS)
    • Table 65 Share Of Drug Label Changes Due To Surveillance For Drugs Used In Allergies 2005 (%)
    • Table 66 Global Forecast Of Drug Label Changes In Due To Surveillance For Git Drugs, Through 2010 (UNITS)
    • Table 67 Share Of Drug Label Changes Due To Surveillance For Git Drugs, 2005 (%)
    • Table 68 Global Forecast Of Drug Label Changes Due To Surveillance For Respiratory Drugs, Through 2010 (UNITS)
    • Table 69 Share Of Drug Label Changes Due To Surveillance For Respiratory Drugs, 2005 (%)
    • Table 70 Global Forecast Of Drug Label Changes Due To Surveillance For Antibiotics, Anti-Fungal, Anti-Malarial Drugs, Through 2010 (UNITS)
    • Table 71 Share Of Drug Label Changes Due To Surveillance For Antibiotics, Anti-Fungal, And Anti-Malarial Drugs, 2005 (%)
    • Table 72 Global Forecast Of Drug Label Changes Due To Surveillance For Miscellaneous Drugs, Through 2010 (UNITS)
    • Table 73 Share Of Drug Label Changes Due To Surveillance For Miscellaneous Drugs, 2005 (%)
    • Table 74 Forecast Of North American Recalls/Withdrawls Of Cardiovascular Drugs By The Fda, Through 2010 (UNITS)
    • Table 75 Forecast Of North American Recalls/Withdrawls Of Mental Disorder Drugs By Fda, Through 2010 (UNITS)
    • Table 76 Forecast Of North American Recalls/Withdrawls Of Urological Disorder Drugs By The Fda, Through 2010 (UNITS)
    • Table 77 Forecast Of North American Recalls/Withdrawls Of Hormones, Contraceptives And Women's Health Products By The Fda, Through 2010 (UNITS)
    • Table 78 Forecast Of North American Recalls/Withdrawls Of Drugs Used To Treat Blood Disorders By The Fda, Through 2010 (UNITS)
    • Table 79 Forecast Of North American Recalls/Withdrawls Of Oncology Drugs By The Fda, 2003-2010 (UNITS)
    • Table 80 Forecast Of North American Recalls/Withdrawls Of Immunosupressant Drugs By The Fda, Through 2010 (UNITS)
    • Table 81 Forecast Of North American Recalls/Withdrawls Of Respiratory Drugs By The Fda, Through 2010 (UNITS)
    • Table 82 Forecast Of North American Recalls/Withdrawls Of Git Drugs By The Fda, Through 2010 (UNITS)
    • Table 83 Forecast Of North American Recalls/Withdrawls Of Antibiotics, Anti-Fungals And Anti-Malarials By The Fda, Through 2010 (UNITS)
    • Table 84 Forecast Of North American Recalls/Withdrawls Of Pain Management, Anesthetics, Anti-Allergics And Anti-Inflammatory Drugs By The Fda, Through 2010 (UNITS)
    • Table 85 Forecast Of North American Recalls/Withdrawls Of Diagnostics By The Fda, Through 2010 (UNITS)
    • Table 86 Forecast Of North American Recalls/Withdrawls Of Miscellaneous Drugs By The Fda, Through 2010 (UNITS)
    • Table 87 Forecast Of North American Recalls/Withdrawls Of Biologicals And Devices By The Fda, Through 2010 (UNITS)
    • Table 88 Forecast Of European Recalls/Withdrawls Of Drug Products By The Emea, Through 2010 (UNITS)
    • Table 89 Forecast Of Recalls/Withdrawls Of Drug Products By The Tga (AUSTRALIA), Through 2010 (UNITS)
    • Table 90 Forecast Of Recalls/Withdrawls Of Drug Products By The Tga, 2003-2010 (By Class Defect)
    • Table 91 Forecast Of Drug Safety Spending By The Fda And Emea By Drug Type, Through 2010 ($ Billions)
  • List Of Figures
    • Summary Figure: Total Approvals And Recalls By Fda And Emea, 2003-2010 (UNITS)
    • Figure 1 Warning Letters Issues By The Fda For Non-Compliance In Glp, 2001-2005
    • Figure 2 Warning Letters Issues By The Fda For Non-Compliance In Gcp, 2001-2005
    • Figure 3 Warning Letter Issues By The Fda For Non-Compliance In Gmp, 2001-2005
    • Figure 4 Warning Letter Issues By The Fda For Non-Compliance In Marketing, 2001-2005
    • Figure 5 Active Inds Approved By Fda, 2003-2010 (UNITS)
    • Figure 6 Inds Existing In Different Phases Of Clinical Trials Approved By The Fda, 2003-2010 (UNITS)
    • Figure 7 Forecast Of North American Ndas Approved By The Fda, Categorized By New Molecular Entity, Through 2010 (UNITS)
    • Figure 8 Forecast Of North American Ndas Approved By The Fda, Categorized By New Ester, New Salt, Or Other Noncovalent Derivative, 2003-2010 (UNITS)
    • Figure 9 Forecast Of North American Ndas Approved By The Fda, Categorized By New Formulation, 2003-2010
    • Figure 10 Forecast Of North American Ndas Approved By The Fda, Categorized By New Combination, 2003-2010 (UNITS)
    • Figure 11 Forecast Of North American Ndas Approved By The Fda, Categorized By New Manufacturer, 2003-2010 (UNITS)
    • Figure 12 Forecast Of North American Ndas Approved By The Fda, For Respiratory Problems, 2003-2010 (UNITS)
    • Figure 13 Forecast Of North American Ndas Approved By The Fda For Cardiac Problems, 2003-2010 (UNITS)
    • Figure 14 Forecast For North American Ndas Approved By Fda, For Pain Management, Anesthetics And Anti-Inflammatory Problems, 2003-2010 (UNITS)
    • Figure 15 Forecast For North American Ndas Approved By The Fda, For Allergies, 2003-2010 (UNITS)
    • Figure 16 Forecast For North American Ndas Approved By The Fda, For Mental Disorders, 2003-2010 (UNITS)
    • Figure 17 Forecast For North American Ndas Approved By The Fda, For Urological Disorders, 2003-2010 (UNITS)
    • Figure 18 Forecast For North American Ndas Approved By The Fda, For Hormones, Contraceptives And Women's Health Products, 2003-2010 (UNITS)
    • Figure 19 Forecast For North American Ndas Approved By The Fda, For Git Problems, 2003-2010 (UNITS)
    • Figure 20 Forecast For North American Ndas Approved By The Fda, For Anti-Microbial Agents, 2003-2010 (UNITS)
    • Figure 21 Forecast For North American Ndas Approved By The Fda, For Oncological Problems, 2003-2010 (UNITS)
    • Figure 22 Forecast For North American Ndas Approved By The Fda, For Immunosuppressant Drugs, 2003-2010 (Units)
    • Figure 23 Forecast For North American Ndas Approved By The Fda, For Ophthalmic Problems, 2003-2010 (Units)
    • Figure 24 Forecast For North American Ndas Approved By The Fda, For Diagnostics, 2003-2010 (Units)
    • Figure 25 Forecast For North American Ndas Approved By The Fda, For Miscellaneous Drugs, 2003-2010 (Units)
    • Figure 26 Forecast For North American Priority And Standard Approvals By The Fda, 2003-2010 (Units)
    • Figure 27 Forecast Of Time Required For Approval Of A Drug By Fda In North America, 2003-2010 (Months)
    • Figure 28 Forecast Of European Products Approved By The Emea, For Cardiac Problems, 2003-2010 (Units)
    • Figure 29 Products Approved By The Emea, For Pain Management, Anesthetics And Anti-Inflammatory Problems, 2003-2010 (Units)
    • Figure 30 Forecast For European Products Approved By Emea, For Mental Disorders, 2003-2010 (Units)
    • Figure 31 Forecast Of European Products Approved By The Emea, For Urological Disorders, 2003-2010 (Units)
    • Figure 32 Forecast Of European Products Approved By The Emea, For Hormones, Contraceptives And Women's Health Products 2003-2010 (Units)
    • Figure 33 Forecast Of European Products Approved By The Emea, For Blood Disorders, 2003-2010 (Units)
    • Figure 34 Forecast Of European Products Approved By The Emea, For Orthopedic Problems, 2003-2010 (Units)
    • Figure 35 Forecast Of European Products Approved By The Emea, For Oncological Problems, 2003-2010 (Units)
    • Figure 36 Products Approved By The Emea, For Immunosuppressant Drugs, 2003-2010 (Units)
    • Figure 37 Forecast Of European Products Approved By The Emea, For Diagnostics, 2003-2010 (Units)
    • Figure 38 Forecast Of European Products Approved By The Emea, For Miscellaneous Drugs, 2003-2010 (Units)
    • Figure 39 Forecast For Approval Time By The Emea 2003-2010 (Months)
    • Figure 40 Global Forecast Of Drug Label Changes Due To Surveillance For Cardiovascular Drugs, 2003-2010 (Units)
    • Figure 41 Share Of Drug Label Changes Due To Surveillance For Cardiovascular Drugs, 2005 (%)
    • Figure 42 Global Forecast Of Drug Label Changes Due To Surveillance For Pain Management, Anesthetics And Anti-Inflammatory Drugs, 2003-2010 (Units)
    • Figure 43 Share Of Drug Label Changes Due To Surveillance For Pain Management, Anesthetics And Anti-Inflammatory Drugs, 2005 (%)
    • Figure 44 Global Forecast Of Drug Label Changes Due To Surveillance For Mental Disorder Drugs, 2003-2010 (Units)
    • Figure 45 Share Of Drug Label Changes Due To Surveillance For Mental Disorder Drugs, 2005 (%)
    • Figure 46 Global Forecast Of Drug Label Changes Due To Surveillance For Urological Disorders Drugs, 2003-2010 (Units)
    • Figure 47 Share Of Drug Label Changes Due To Surveillance For Urological Disorders Drugs, 2005 (%)
    • Figure 48 Global Forecast Of Drug Label Changes Due To Surveillance For Hormones, Contraceptives And Women's Health Products, 2003-2010 (Units)
    • Figure 49 Share Of Drug Label Changes Due To Surveillance For Hormones, Contraceptives And Women's Health Products, 2005 (%)
    • Figure 50 Global Forecast Of Drug Label Changes Due To Surveillance For Drugs Used To Treat Blood Disorder, 2003-2010 (%)
    • Figure 51 Share Of Drug Label Changes Due To Surveillance For Drugs Used To Treat Blood Disorders, 2005 (%)
    • Figure 52 Global Forecast Of In Drug Label Changes Due To Surveillance For Orthopedic Drugs, 2003-2010 (Units)
    • Figure 53 Share Of Drug Label Changes Due To Surveillance For Orthopedic Drugs, 2005 (%)
    • Figure 54 Global Forecast Of Drug Label Changes Due To Surveillance For Oncology Drugs, 2003-2010 (Units)
    • Figure 55 Share Of Drug Label Changes Due To Surveillance For Oncology Drugs, 2005 (%)
    • Figure 56 Global Forecast Of Drug Label Changes Due To Surveillance For Immunosupressant Drugs, 2003-2010 (Units)
    • Figure 57 Share Of Drug Label Changes Due To Surveillance For Immunosuppressant Drugs, 2005 (%)
    • Figure 58 Global Forecast Of Drug Label Changes In Due To Surveillance For Drugs Used In Allergies, 2003-2010 (Units)
    • Figure 59 Share Of Drug Label Changes Due To Surveillance For Drugs Used In Allergies, 2005 (%)
    • Figure 60 Global Forecast Of Drug Labels Changes Due To Surveillance For Git Drugs, 2003-2010 (Units)
    • Figure 61 Share Of Drug Label Changes Due To Surveillance For Git Drugs, 2005 (%)
    • Figure 62 Global Forecast Of Drug Label Changes Due To Surveillance For Respiratory Drugs, 2003-2010 (Units)
    • Figure 63 Share Of Drug Label Changes Due To Surveillance For Respiratory Drugs, 2005 (%)
    • Figure 64 Global Forecast Of Drug Label Changes Due To Surveillance For Antibiotics, Anti-Fungal, And Anti-Malarial Drugs, 2003-2010 (Units)
    • Figure 65 Share Of Drug Label Changes Due To Surveillance For Antibiotics, Anti-Fungal, And Anti-Malarial Drugs, 2005 (%)
    • Figure 66 Global Forecast Of Drug Labels Changes Due To Surveillance For Miscellaneous Drugs, 2003-2010 (Units)
    • Figure 67 Share Of Drug Label Changes Due To Surveillance For Miscellaneous Drugs, 2005 (%)
    • Figure 68 Forecast Of North American Recalls/Withdrawls Of Cardiovascular Drugs By The Fda, 2003-2010 (Units)
    • Figure 69 Forecast Of North American Recalls/Withdrawls Of Mental Disorder Drugs By Fda, 2003-2010 (Units)
    • Figure 70 Forecast Of North American Recalls/Withdrawls Of Urological Disorder Drugs By The Fda, 2003-2010 (Units)
    • Figure 71 Forecast Of North American Recalls/Withdrawls Of Hormones, Contraceptives And Women's Health Products By The Fda, 2003-2010 (Units)
    • Figure 72 Forecast Of North American Recalls/Withdrawls Of Drugs Used To Treat Blood Disorders By The Fda, 2003-2010 (Units)
    • Figure 73 Forecast Of North American Recalls/Withdrawls Of Oncology Drugs By The Fda, 2003-2010 (Units)
    • Figure 74 Forecast Of North American Recalls/Withdrawls Of Immunosupressant Drugs By The Fda, 2003-2010 (Units)
    • Figure 75 Forecast Of North American Recalls/Withdrawls Of Respiratory Drugs By The Fda, 2003-2010 (Units)
    • Figure 76 Forecast Of North American Recalls/Withdrawls Of Git Drugs By The Fda, 2003-2010 (Units)
    • Figure 77 Forecast Of North American Recalls/Withdrawls Of Antibiotics, Antifungals And Anti-Malarials By The Fda, 2003-2010 (Units)
    • Figure 78 Forecast Of North American Recalls/Withdrawls Of Pain Management, Anesthetics, Anti-Allergics And Anti-Inflammatory Drugs By The Fda, 2003-2010 (Units)
    • Figure 79 Forecast Of North American Recalls/Withdrawls Of Diagnostics By The Fda, 2003-2010 (Units)
    • Figure 80 Forecast Of North American Recalls/Withdrawls Of Miscellaneous Drugs By The Fda, 2003-2010 (Units)
    • Figure 81 Forecast Of North American Recalls/Withdrawls Of Biologicals And Devices By The Fda, 2003-2010 (Units)
    • Figure 82 Forecats Of European Recalls/Withdrawls Of Drug Products By The Emea, 2003-2010 (Units)
    • Figure 83 Forecast Of Recalls/Withdrawls Of Drug Products By The Tga, 2003-2010 (Units)
    • Figure 84 Forecast Of Recalls/Withdrawls Of Drug Products By The Tga, 2003-2010 (By Class Defect)
    • Figure 85 Forecast Of Drug Safety Spending By The Fda And Emea By Drug Type, 2003-2010 ($ Billions)