1. Orphan drugs in Japan;Uchida;Drug Inf. J.,1996
2. European Parliament and Council (2000) Official Journal of the European Communities L18, 1–5 (available at http://pharmacos.eudra.org/orphanmp/doc/141_2000/141_2000_en.pdf)
3. European Commission (2000) Commission Regulation Laying Down the Provisions of Implementation of the Criteria for the Designation of a Medicinal Product as an Orphan Medicinal Product and Definitions of the Concepts of ‘Similar Medicinal Product’ and ‘Clinical Superiority’ (available at http://pharmacos.eudra.org/orphanmp/doc/regv5_en.pdf)