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Orphan Drug Regulation in Europe – Fall 2001

Post thumbnail Orphan Drug Regulation in Europe – Fall 2001

Rare diseases are referred to as “orphan diseases”, and the products intended to treat them as “orphan medicinal products”. In addition to rare diseases, orphan diseases include those for which developing new therapeutic tools is not profitable. Following the international examples of the United States, Australia and Japan, Europe adopted its “Orphan Regulation” on December 16, 1999 (European Commission Regulations EC No. 141/2000 (1) and EC No. 847/2000 (2)).

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    publication by

    Emmanuelle M. Voisin, PhD
    Emmanuelle M. Voisin, PhD
    Founder and CEO
    Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech,…
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