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A Comparison of the Drug Review Process at Five International Regulatory Agencies

  • Drug Development
  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process across five regulatory agencies in the United States, Europe, Canada, Switzerland, and Australia. Four main stages (receipt of data, scientific assessment, sponsor response, and authorization of the product) that are common across all these agencies have been identified and “milestone” dates were collected for over 1,000 new active substance (NAS) applications. Data were collected by year of submission between 1997 and 2002, which allowed cohorts of compounds to be tracked prospectively to approval, rejection, or withdrawal and ensured that the products had been reviewed in the same regulatory environment. Analyses of the mean/median time intervals between milestones and the overall review times were carried out. Twenty-nine NASs that were submitted to, and approved by, all five agencies were also identified and studied in more depth. Overall median approval times ranged across agencies from 368 to 595 days. This study showed that, although the stages in the review process may be common for the different agencies, the time that an application spends in each stage can differ significantly. The order in which activities are undertaken in the review process also differs, for example, the timing of advisory committees or stages in the process carried out in parallel rather than sequentially. The data suggest that the differences in the way projects are managed in the review process has an impact on the review times.

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References

  1. McAuslane N, Anderson C, Walker S. The Changing Regulatory Environment:Reality and Perception. Epsom, UK: CMR International; 2004. R+D Briefing 42.

    Google Scholar 

  2. DiMasi J, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs.J Health Econ. 2003;22:151–185.

    Article  Google Scholar 

  3. Similarities and Differences in Regulatory Approval Times. Profile of Performance (2). R&D Briefing 21. CMR International: 1999. Available at: http://www.cmr.org/pdf/rd21.pdf. Accessed December 14, 2005.

  4. Rawson NSB. Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996–1998.Can Med Assoc J. 2000;162:501–504.

    CAS  Google Scholar 

  5. Rawson NSB, Kaitin KI. New drug approval times and "therapeutic potential" in Canada, Australia, Sweden and the United States during the period 1992 to 1998.Can J Clin Pharmacol. 2000;7:97–101.

    CAS  PubMed  Google Scholar 

  6. Tufts CSDD. User Fees Credited With 51% Drop in Average Approval Times Since 1993. Tufts Center for the Study of Drug Development, Impact report 2000: Vol. 2, October. Available at: http://csdd.tufts.edu/InfoServices/lmpactReports.asp. Accessed January 5, 2006.

  7. Anderson C, McAuslane N, Walker S. The Impact of the Changing Regulatory Environment on Review Times. R&D Briefing No. 35, CMR International; 2002. Available at: http://www.cmr.org/pdf/r_d35.pdf. Accessed December 14, 2005.

  8. Rawson NSB. Timeliness of review and approval of new drugs in Canada from 1999 through 2001: is progress being made? Clin Ther. 2003;25:1230–1247.

    Article  Google Scholar 

  9. Sauer F. Current regulatory reforms and improvements in the review process. In: McAuslane N, Walker S, eds. Improving the Regulatory Review Process: Assessing Performance and Setting Targets. Dordrecht, The Netherlands: Kluwer Academic; 1997:13–19.

    Chapter  Google Scholar 

  10. Thomas K. The approval of new pharmaceutical compounds: what can we learn from comparing the performance of international regulatory authorities? Reg Rev. June 1998:3–7.

    Google Scholar 

  11. Thomas K. Key milestones in the regulatory review process. In: McAuslane N, Walker S. eds. Improving the Regulatory Review Process: Assessing Performance and Setting Targets. Dordrecht. The Netherlands: Kluwer Academic; 1997:87–113.

    Chapter  Google Scholar 

  12. WHO Collaborating Centre for Drug Statistics and Methodology Web site. Available at: http://www.whocc.no/atcddd/. Accessed January 5, 2006.

  13. Regulatory Review of Pharmaceuticals, Biologics and Medical Devices, 2004 Annual Summary of Performance. Health Products and Food Branch, Health Canada; 2004. Available at: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/performance_rendement_2004_e.html. Accessed January 5, 2006.

  14. Van den Haak MA, Lumley CE, McAuslane JAN. Pharmaceutical Investment and Output Survey 2001: Annual Report. Epsom, UK: CMR International Institute for Regulatory Science; 2003. CMR02–171AR.

    Google Scholar 

  15. Guidance for Industry, Management of Drug Submissions. Health Products and Food Branch Guidance Document, Health Canada: 2003. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharmdapplic-demande/guide-ld/mgmt-gest/mandsgespd-gespd_e.html. Accessed January 5, 2006.

  16. PDUFA Reauthorisation Performance Goals and Procedures. FDA: 1997. Available at: http://www.fda.gov/cder/news/pdufagoals.htm. Accessed January 5, 2006.

  17. Australian Regulatory Guidelines for Prescription Medicines. Therapeutic Goods Administration: 2004. Available at: http://www.tga.gov.au/pmeds/argpm.htm. Accessed January 5, 2006.

  18. Guidance for Review Staff and Industry. Good Review Management Principles and Practices for PDUFA Products. FDA: 2005. Available at: htlp://www.fda.gov/cber/gdlns/reviewpdufa.htm. Accessed January 5, 2006.

  19. Tenth Annual Report of the European Medicines Agency: EMEA; 2004:27. Available at: http://www.emea.eu.int/pdfs/general/direct/emeaar/ar6149205en.pdf. Accessed January 5, 2006.

  20. Hunt L. How benchmarking is being used to streamline and change regulatory processes: Australian perspective. In: Cone MC. Walker S. eds. Beyond Benchmarking: What Are the Key Metrics That Agencies and Companies Should Use to Measure Performance? Epsom, Surrey, UK: CMR International Institute Workshop Report: 2005.

    Google Scholar 

  21. Olson MK. How have user fees affected the FDA? Regulation. Spring 2002:20–25.

    Google Scholar 

  22. Tufts CSDD. User Fees Credited With 51% Drop in Average Approval Times Since 1993. Tufts Center for the Study of Drug Development. Impact Report 2000. Vol. 2, October. Available at: http://csdd.tufts.edu/lnfoServices/lmpactReporls.asp. Accessed January 5, 2006.

  23. Mallia-Milanes A. An Evaluation of Quality Measures Applied to the Regulatory Review Process of Major Regulatory Authorities [Master of Philosophy thesis]. Cardiff, Wales: University of Wales: 2006.

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Author notes

  1. Mayu Hirako BSc, PhD (Project Manger)

    Present address: GlaxoSmithKline, Greenford, Middlesex, UK

  2. Carly Anderson BSc, PhD (Project Manager)

    Present address: Eli Lilly and Company Limited, Windlesham, Surrey, UK

Authors and Affiliations

  1. CMR International Institute for Regulatory Science, Novellus Court, 61 South Street, KT18 7PX, Epsom, Surrey, UK

    Mayu Hirako BSc, PhD (Project Manger),  Neil McAuslane BSc, MSc, PhD (Director) & Stuart Walker BSc, PhD, MFPM, FRSC, FIBiol, FinstD, FRCPath (Vice President and Founder)

  2. Pharmaceutical Medicine, Welsh School of Pharmacy, Cardiff University, UK

    Sam Salek BSc, RPh, PhD, MFPM (Professor in Pharmacoepidemiology, Director-Centre for Socioeconomic Research and Director-Postgraduate Course)

  3. CMR International Limited, UK

    Carly Anderson BSc, PhD (Project Manager)

Authors
  1. Mayu Hirako BSc, PhD
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  2. Neil McAuslane BSc, MSc, PhD
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  3. Sam Salek BSc, RPh, PhD, MFPM
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  4. Carly Anderson BSc, PhD
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  5. Stuart Walker BSc, PhD, MFPM, FRSC, FIBiol, FinstD, FRCPath
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Corresponding author

Correspondence to Neil McAuslane BSc, MSc, PhD.

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Hirako, M., McAuslane, N., Salek, S. et al. A Comparison of the Drug Review Process at Five International Regulatory Agencies. Ther Innov Regul Sci 41, 291–308 (2007). https://doi.org/10.1177/009286150704100302

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  • DOI: https://doi.org/10.1177/009286150704100302

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