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

Source: CMR International FDA/002 Region of first launch New Molecular Entities First Launched Onto World Market IO

Source: CMR International FDA/003 Mean Development Times for NASs Launched in * BM Code Assigned 1st Dose in human 1st Submission 1st Launch 28% 61% 11% *with all dates available

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 RG

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 RG

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

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

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

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

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

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

Source: CMR International FDA/0012 Improving the Regulatory Review Process QualityResources Time Benchmarking Essential strategies for future success in the Regulatory Review BM

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

Source: CMR International FDA/0014 Median Approval Times in Major Markets 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.

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 & % in 6 months 30% in 10 months 90% in 12 months PDUFA II targets for 1999

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