Skip to main content
SpringerLink
Log in

Preparing for Regulatory Review and Reimbursement Decisions

A Case for Cooperation between Regulatory Authorities, Sponsors and Health Technology Assessment Agencies

  • Editorial
  • Published:
Pharmaceutical Medicine Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I

References

  1. Attridge J. Innovation models and their application to the pharmaceutical sector. 2006; discussion paper 2: 1–19 [online]. Available from URL: http://www3.imperial.ac.uk/portal/pls/portallive/docs/1/7290711.PDF [Accessed 2009 Nov 27]

    Google Scholar 

  2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. History and future of ICH [online]. Available from URL: http://www.ich.org/cache/compo/276-254-1.html [Accessed 2009 Nov 27]

  3. Hunter AJ. The innovative medicines initiative: a pre-competitive initiative to enhance the biomedical science base of Europe to expedite the development of new medicines for patients. Drug Discov Today 2008; 13: 371–3

    Article  PubMed  Google Scholar 

  4. United States Food and Drug Administration. FDA critical path initiative announcement [online]. Available from URL: http://www.trialstransformation.org/fda-critical-path-initiative-press-release/ [Accessed 2009 Nov 27]

  5. Siva N. The drug price is right: or is it? Lancet 2009; 373: 1326–7

    Article  PubMed  Google Scholar 

  6. Eichler HG. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 2008; 7: 818–26

    Article  PubMed  CAS  Google Scholar 

  7. Breckenridge A, Walley T. Early access to medicines. Clin Pharm Ther 2008; 84: 23–5

    CAS  Google Scholar 

  8. Strom BL. How the US drug safety system should be changed. JAMA 2006; 295: 2072–5

    Article  PubMed  CAS  Google Scholar 

  9. Lucas F, Easley C. A focus on commercial innovation and risk sharing. Axiom Dig 2009; 9–11 [online]. Available from URL: http://www.popewoodhead.com/downloads/Axiom_Digest_09.pdf [Accessed 2009 Nov 27]

    Google Scholar 

Download references

Acknowledgements

This article benefited from the review of Dr Mel Walker, GlaxoSmithKline. The authors also acknowledge the inclusion of concepts presented by Dr Eric Abadie, Committee for Medicinal Products for Human Use at the European Medicines Agency; Dr Hilary Malone, Wyeth Laboratories; Clare McGrath, Pfizer Laboratories; Professor Robert Peterson, University of British Columbia; and Dr Ad Shuurman, Medicine Evaluation Committee at the workshop entitled “Review and reimburse-ment: a special case for better co-operation” held 29–30 September 2009, Surrey, UK, and sponsored by the Institute (http://www.cmr.org

Author information

Authors and Affiliations

  1. CMR International Institute for Regulatory Science, The Johnson Building, 77 Hatton Garden, London, EC1N8JS, UK

    Lawrence E. Liberti, Franz Pichler & Stuart R. Walker

Authors
  1. Lawrence E. Liberti
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Franz Pichler
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Stuart R. Walker
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lawrence E. Liberti.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Liberti, L.E., Pichler, F. & Walker, S.R. Preparing for Regulatory Review and Reimbursement Decisions. Pharm Med 23, 263–267 (2009). https://doi.org/10.1007/BF03256778

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF03256778

Search

Navigation