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Review
. 2007 Oct 20;335(7624):803-5.
doi: 10.1136/bmj.39281.615706.94.

How can we regulate medicines better?

Silvio Garattini  1 , Vittorio Bertele'
Affiliations
Review

How can we regulate medicines better?

Silvio Garattini et al. BMJ. .

Abstract

Current European licensing regulations give precedence to the interests of drug companies. Silvio Garattini and Vittorio Bertele' suggest changes to ensure they meet the needs of patients and doctors

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Conflict of interest statement

Competing interests: SG and VB are director and researcher at the Mario Negri Institute for Pharmacological Research, an independent non-profit research institute devoted to patients' and national health services' interests. The Institute could take advantage of the proposal to increase the role of independent research in setting up the documentation supporting marketing authorization applications for new drugs or new clinical indications.

References

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    1. Mossialos E, Walley T, Mrazek M. Regulating pharmaceutical in Europe: an overview. In: Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality Maidenhead: Open University Press, 2004:1-37.
    1. Medicine in Europe: the most important changes in the new legislation. Prescrire Int 2004;13:1581-8.
    1. Apolone G, Joppi R, Bertele' V, Garattini S. Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures. Br J Cancer 2005;93:504-9. - PMC - PubMed
    1. Garattini S, Bertele' V, Li Bassi L. How can research ethics committees protect patients better? BMJ 2003;326:1199-201. - PMC - PubMed