1. Professor Stuart Walker BSc PhD MFPM FIBiol FRSC FRCPath FIstD Director CMR International UK

2. Source: CMR International FDA/002 Region of first launch New Molecular Entities First Launched Onto World Market 1990-1999 IO4 0010 120100

3. Source: CMR International FDA/003 Mean Development Times for NASs Launched in 1994- 1998* BM2 4220 170999 Code Assigned 1st Dose in human 1st Submission 1st Launch 28% 61% 11% *with all dates available

4. Source: CMR International FDA/004 Key Measures of Regulatory Performance Performance Efficiency Quality Efficiency and quality are inextricably bound to each other. They are the ‘ying and yang’ of both the review process and of the process used by industry to compile the application. Lumpkin 1997 RG10 0370

5. Source: CMR International FDA/005 Building Quality into the Regulatory Review  QA methods in use  Training & continuing education of reviewers  Accreditation of review practice  Peer & committee review  Reviewer input into drug development  Shared & joint reviews  Transparency  Post approval analysis  Resources  Australia, Canada, France, Japan, Netherlands, Sweden, Switzerland, UK & FDA RG10 0960

6. Source: CMR International FDA/006 Quality Assurance Measures Currently in Place CDER, FDA

7. Source: CMR International FDA/007 Level of Contact Reviewers Have With the Sponsor During Both the Development and Review Process CDER, FDA

8. Source: CMR International FDA/008 Information on Review of New Drug Applications Made Publicly Available CDER, FDA

9. Source: CMR International FDA/009 Standard Fee for a Review of a New Active Substance

10. Source: CMR International FDA/0010 Resources Available to Authorities in Terms of Full Time Equivalents

11. Source: CMR International FDA/0011 Proportion of Total Annual Budget Derived From User Fees

12. Source: CMR International FDA/0012 Improving the Regulatory Review Process QualityResources Time Benchmarking Essential strategies for future success in the Regulatory Review BM1 0020 210198

13. Source: CMR International FDA/0013 Proportion of ‘98 & ‘99 Approvals Granted Within Two Years

14. Source: CMR International FDA/0014 Median Approval Times in Major Markets 1990-1999 PDUFA I PDUFA II Evaluation User Fees Evaluation User Fees Procedure implemented Procedure implemented * Approval times for the MR are from the date of application to RMS to the end of the 90-day discussion phase.

15. Source: CMR International FDA/0015  = median. (n)= number of applications. Box: 25th and 75th percentiles; Whiskers: 5th and 95th percentiles. Comparison of Approval Times for Priority and Non- priority Compounds Approved in 1998 & 1999 90% in 6 months 30% in 10 months 90% in 12 months PDUFA II targets for 1999

16. Source: CMR International FDA/0016 Regulatory Approval Time for Compounds Submitted to the USA and the EU Via the Centralised Procedure Within 1 Month (1995-1999)