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. 2007 May;2(4):114-22.

Notice of compliance with conditions: a policy in limbo

Joel Lexchin  1
Affiliations

Notice of compliance with conditions: a policy in limbo

Joel Lexchin. Healthc Policy. 2007 May.

Abstract
in English, French

Since 1998, the Therapeutic Products Directorate (TPD) has had a policy termed the Notice of Compliance with conditions (NOC/c) in order to allow earlier marketing of promising drugs for serious conditions before the drugs have definitively demonstrated clinical efficacy. Drugs approved under the NOC/c must undergo post-marketing trials to show clinical benefits. The reasons that some drugs receive a NOC/c are not always apparent, and the TPD releases only general information regarding the conditions that need to be fulfilled. Some drugs have fulfilled their conditions in under 1.4 years, but others had unfulfilled conditions after seven years. Doctors may not be aware that drugs are marketed with a NOC/c nor that some drugs have had their NOC/c withdrawn, and as a consequence may be prescribing inappropriately for their patients. Other jurisdictions have similar policies but with stricter and more transparent requirements. Adopting these provisions, along with other reforms, could help ensure that the NOC/c policy meets it objectives.

Les avis de conformité conditionnels (ACC) sont une politique en place à la Direction des produits thérapeutiques (DPT) depuis 1998 et visent à permettre une mise en marché anticipée de médicaments prometteurs conçus pour traiter des maladies graves avant que ces médicaments aient démontré leur efficacité clinique de façon certaine. Les médicaments faisant l’objet d’un ACC doivent être soumis à des essais après leur mise en marché afin d’en démontrer les avantages cliniques. Les raisons motivant l’assujettissement de certains médicaments à un ACC ne sont pas toujours apparentes et la DPT ne diffuse que des renseignements généraux sur les conditions qui doi-vent être remplies. Certains médicaments ont satisfait aux conditions qui leur étaient imposées en moins de 1,4 année, tandis que d’autres ne l’avaient toujours pas fait après sept ans. Les médecins peuvent ne pas savoir que des médicaments sur le marché sont assortis d’un ACC ou que l’ACC de certains médicaments a été retiré, et, par conséquent, peuvent donner des ordonnances inappropriées à leurs patients. D’autres sec-teurs de compétence ont des politiques semblables mais avec des exigences plus strictes et plus transparentes. L’adoption de ces dispositions, ainsi que d’autres réformes, pourrait aider à s’assurer que la politique des ACC atteigne ses objectifs.

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References

    1. Approval of Ebixa® with Conditions. 2004. Retrieved April 13, 2007. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/ebixa_... .
    1. Approval with Conditions of Femara®-2.5 mg for Use in the Extended Adjuvant Treatment of Hormone Receptor-Positive Early Breast Cancer in Postmenopausal Women Who Have Received Approximately 5 Years of Prior Standard Adjuvant Tamoxifen Therapy. 2005. Retrieved April 13, 2007. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/femara... .
    1. Bensimon G., Lacomblez L., Meininger V. A Controlled Trial of Riluzole in Amyotrophic Lateral Sclerosis. ALS/Riluzole Study Group. New England Journal of Medicine. 1994;330:585–91. - PubMed
    1. Committee for Medicinal Products for Human Use (CHMP) Guideline on the Scientific Application and the Practical Arrangements Necessary to Implement Commission Regulation (EC) No. 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use Falling within the Scope of Regulation (EC) No. 726/2004. 2006. Retrieved April 13, 2007. http://www.emea.eu.int/htms/general/direct/legislation/legislationhuman.htm .
    1. Cooper N.J., Sutton A.J., Abrams K.R., Wailoo A., Turner D., Nicholson K.G. Effectiveness of Neuraminidase Inhibitors in Treatment and Prevention of Influenza A and B: Systematic Review and Meta-analyses of Randomised Controlled Trials. British Medical Journal. 2003;326:1235–40. - PMC - PubMed

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