IDEAS home Printed from https://ideas.repec.org/a/oup/scippl/v25y1998i3p155-169.html
   My bibliography  Save this article

Making harmonisation work: The politics of scientific expertise in European medicines regulation

Author

Listed:
  • Graham Lewis
  • John Abraham

Abstract

European-wide harmonisation of regulation in medicines is more successful than previously because of political, bureaucratic and institutional changes, which have induced regulators to compromise and reach consensus. It is being driven by a convergence of the institutional interests of national regulatory agencies and the industry in rapid drug approvals. This mutual recognition system involves national regulatory agencies competing for regulatory work. Mutual recognition extends peer review but may be less critical, because regulators may not have time to check thoroughly evaluations of other Member States. Furthermore, the compressed time frames of that peer review are leading to a diminished role for national expert science advisory committees, which traditionally have provided an important ‘independent’ form of peer review. Copyright , Beech Tree Publishing.

Suggested Citation

  • Graham Lewis & John Abraham, 1998. "Making harmonisation work: The politics of scientific expertise in European medicines regulation," Science and Public Policy, Oxford University Press, vol. 25(3), pages 155-169, June.
    • Handle: RePEc:oup:scippl:v:25:y:1998:i:3:p:155-169
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1093/spp/25.3.155
    Download Restriction: Access to full text is restricted to subscribers.
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Morris, Norma, 2000. "Vial bodies: conflicting interests in the move to new institutional relationships in biological medicines research and regulation," Research Policy, Elsevier, vol. 29(2), pages 149-167, February.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:oup:scippl:v:25:y:1998:i:3:p:155-169. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Oxford University Press (email available below). General contact details of provider: https://academic.oup.com/spp .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.