米国食品医薬品局（FDA）および 欧州医薬品審査庁（EMEA）における医薬品認可の動向

Drug safety has become a major industry concern following the market withdrawal of Merck' s Vioxx in 2004 and several other discontinuations of COX-2 inhibitors. Although adverse reactions were previously considered a relatively minor risk compared to a drug' s wider benefit, both newly approved and established drugs are now under intense scrutiny. Drug approvals in the US and Europe have become subject to approval delays, rising requests for further clinical data, and greater chances of rejection. Regulators are currently attempting to reconfigure review processes in order to minimize delays in recognition of the potential mass benefits of new applications Drug Approval Trends at the FDA and EMEA: Process improvements, heightened scrutiny and industry response is a new report published by Business Insights that provides a comprehensive review of current drug approval trends in the US and Europe with case studies highlighting successful and unsuccessful applications. Emerging regulatory developments and process improvements are examined and the strategic measures implemented by developers to enhance the approval potential of their drugs are assessed.

This report also evaluates the future regulatory landscapes of the FDA and EMEA, with a review of anticipated developments through to 2012. Understand the changing landscape for FDA and EMEA drug approvals, discover the implications of process overhauls upon your drug applications and anticipate future regulatory developments with this new report.

Table of Contents

• The shifting regulatory landscape
• Drug approval trends at FDA
• Drug approval trends at EMEA
• Industry response
• Global drug approval trends through 2012

• Summary
• Drug usage in the U.S. and Europe
• New molecular entities

• Generic drugs
• Rising usage of generics
• Generic drug application trends
• Indication expansions
• Drug approval issues
• Ensuring drug safety
• Safety shortfalls: rising adverse drug reactions
• Safety failures: drug withdrawals
• The importance of time to market
• Impact of cost constraints
• Conclusion

• Summary
• Drug approval process
• Pressure to approve drug candidates
• Future directions in the FDA drug approval process
• Ensuring drug safety
• Evolution of drug safety testing
• Pediatric safety testing

• Future directions in drug safety reviews
• Reducing time to market
• Fast track approvals
• Orphan drug approvals
• Decreasing FDA drug approvals
• Future directions in speeding drug approvals
• Delaying risky applications
• Rising data requirements
  • Case study: hormone replacement therapy
  • Case study: Galvus
• The future for risky drug applications
• Biosimilars
• The future of biosimilar approvals
• Canadian biosimilars legislation

• Rx-to-OTC switches
• New OTC drug categories
  • Antihistamines
  • Emergency contraceptives
  • Hyperosmotic laxatives
  • Ophthalmic allergy medications
  • Proton pump inhibitors
  • Weight loss medications
• Switch rejections
• Statins

• Future directions in nonprescription drug approvals
• Creation of a pharmacist dispensed class
• Marketing withdrawals
• Application withdrawals
• Future directions in marketing and application withdrawals
• Conclusion

• Summary
• Drug approval process
• History of European drug regulation
• The formation of the EMEA and the MRP

• The EMEA
• The Mutual Recognition Procedure (MRP)
• The National Competent Authorities
• The Common Technical Document
• Ensuring drug safety
• Creation of Scientific Advisory Groups

• Future directions in drug safety testing
• Reducing time to market
• Accelerated opinions
• Pediatric testing exemptions
• Decreasing EMEA approvals vs. FDA approvals
• Current EMEA approval levels
• Future directions in speeding drug approvals

• Delaying risky applications
• The future for risky drug applications

• Biosimilars
• New biosimilar guidelines
• Future directions in biosimilar approvals

• Rx-to-OTC switches
• Future directions in nonprescription drug approvals
• Marketing withdrawals
• Application withdrawals
• Future directions in marketing and application withdrawals
• Conclusion

• Summary
• Background
• Improving safety testing
• Genomics
• Stem cell approaches
• Future drug safety testing improvements

• Raising investment in R&D
• Improving R&D productivity
  • Contract research organizations
• Repositioning
• Future directions in R&D investment
• Public reporting of clinical study results
• United States
• Europe
• Association of the British Pharmaceutical Industry

• Future directions in clinical data reporting
• Strengthening regulatory processes
• Coalition for a Stronger FDA
• Future directions in regulatory support
• Conclusion

• Summary
• Background
• Trends at the FDA
• Focus on drug safety
  • New technology-based standards for drug application review
• Decreasing application review times
• Boosting integrity and accountability

• Trends at the EMEA
• Focus on drug safety
• Product Information Management (PIM) Project
• Cooperation with other regulators
• Incentives for small drug developers
• Convergence of regulatory approaches
• Orphan drug approvals
• Conclusion

Index

• Figure 1.1: Drug safety risk spectrum
• Figure 1.2: Growth in U.S. reported adverse drug reactions, 1995 - 2007
• Figure 1.3: U.S. R&D spending versus new drug approvals, 1995 - 2007
• Figure 2.4: U.S. drug approvals, 1995 - 2007
• Figure 3.5: Average number of days for centralized procedure positive opinions, 2004 - 2006
• Figure 3.6: Average number of days for orphan drug designation opinions, 2004 - 2006
• Figure 3.7: EMEA marketing withdrawals, 2000 - 2007

• Table 1.1: Selected indication expansions for U.S. commercialized drugs, 2002 - 2007
• Table 1.2: Potential safety risks of popular drug classes
• Table 1.3: Significant drug discontinuations and affected patient groups, 1997 - 2007
• Table 2.4: Timeline of key FDA legislations
• Table 2.5: CDER Advisory Committees, 2008
• Table 2.6: U.S. New Molecular Entity (NME) Approvals, 2000 - 2007
• Table 2.7: Key U.S. Rx-to-OTC switches, 1997 - 2007
• Table 2.8: Key events in the approval of OTC nonsedating antihistamines
• Table 2.9: Recent withdrawals of U.S. marketing applications, 2002 - 2007
• Table 3.10: Leading European National Competent Authorities, 2008
• Table 4.11: U.S. Clinical trials and R&D spending, 2000 - 2007
• Table 4.12: Selected repositioning specialists