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The regulatory control of non-steroidal anti-inflammatory agents

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Summary

The number of marketed non-steroidal anti-inflammatory agents varies widely from one European country to another, partly as a consequence of differing regulatory policies. During a four-year period, nine of 18 applications to market such drugs in the Netherlands failed; the remaining nine compounds were all licenced; in all, 22 single drug entities of this type are currently on sale. In Norway during the same period none of the 15 applications received was granted, though five cases are still pending; only seven such drugs are currently licenced for sale. The reasons for the national decisions and for the discrepancies between them are analyzed. A study of the prescribing practice of rheumatologists in the two countries suggests that some 10 to 15 products of this type are in fact needed in order to provide a reasonable choice. Current registration trends could markedly discourage further research investment in this field unless in the near future a basis is found for developing non-steroidal anti-inflammatory drugs with distinct advantages as compared with all those so far known.

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Authors and Affiliations

  1. Netherlands Committee for the Evaluation of Medicines, Rijswijk, The Netherlands

    M. N. G. Dukes & I. Lunde

  2. National Centre for Medicinal Products Control, Oslo, Norway

    M. N. G. Dukes & I. Lunde

Authors
  1. M. N. G. Dukes
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  2. I. Lunde
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Dukes, M.N.G., Lunde, I. The regulatory control of non-steroidal anti-inflammatory agents. Eur J Clin Pharmacol 19, 3–10 (1981). https://doi.org/10.1007/BF00558371

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