References
- Garattini S, Bertele V. Efficacy, safety, and cost of new anticancer drugs. Br Med J 2002; 325: 269–271.
- Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal productsforhumanuse.Availableat http://pharmacos.eudra.org/F2/review/doc/finalpubl/Dir20042720040430EN.pdf.
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and estab-lishing a European Medicines Agency. Available at http://pharmacos.eudra.org/F2/review/doc/finalpubl/Reg200472620040430EN.pdf.
- CPMP/EWP/205/95 Note for Guidance on Evaluation of Anticancer Medicinal Products in Man Revision 2 (CPMP adoptedJuly2003).Availableat http://www.emea.eu.int/pdfs/human/ewp/020595en.pdf.
- CPMP/EWP/569/02 Addendum on Paediatric Oncology (CPMP released for consultation July 2003). Availableat http://www.emea.eu.int/pdfs/human/ewp/056902en.pdf.
- CHMP/EWP/1068/04 Concept Paper on the Recommendation on the need for Revision of the CPMP Note for Guidance on Evaluation of Anticancer Medicinal Products in Man (dated 29 July 2004). Available at http://www.emea.eu.int/pdfs/human/ewp/106804en.pdf.