12.07.2015 Views

European Union centralised procedure for marketing ... - INCT-Inofar

European Union centralised procedure for marketing ... - INCT-Inofar

European Union centralised procedure for marketing ... - INCT-Inofar

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

E U RO P E A N J O U R NA L O F CA N C E R42 (2006) 446– 455 455AcknowledgementsThe author thanks Dr. Francesco Pignatti of the EMEA <strong>for</strong> histhorough review and valuable input regarding thismanuscript.REFERENCES1. Pignatti F, Aronsson B, Vamvakas S, et al. Clinical trials <strong>for</strong>registration in the <strong>European</strong> <strong>Union</strong>: the EMEA 5-year experiencein oncology. Crit Rev Onc Hematol 2002;42:123–35.2. Regulation (EC) 726/2004 of 30th April 2004 laying downcommunity <strong>procedure</strong>s <strong>for</strong> the authorisation and supervisionof medicinal products <strong>for</strong> human and veterinary use andestablishing a <strong>European</strong> Medicines Agency. Official J Eur <strong>Union</strong>2004;L136:1–33.3. Regulation (EC) 141/2000 of 22nd January 2000 on orphanmedicinal products. Official J Eur <strong>Union</strong> 2000;L18:1–5.4. Commission Directive 2003/63/EC of 25th June 2003 amendingDirective 2001/83/EC of the <strong>European</strong> Parliament and of theCouncil on the Community code relating to medicinal products<strong>for</strong> human use. Official J Eur <strong>Union</strong> 2003;L159:46–94.5. <strong>European</strong> Agency <strong>for</strong> the Evaluation of Medicinal Products.Note <strong>for</strong> guidance on evaluation of anticancer medicinalproducts in man (CPMP/EWP/205/95 rev. 2). <strong>European</strong> Agency<strong>for</strong> the Evaluation of Medicinal Products London, 2002.6. <strong>European</strong> Agency <strong>for</strong> the Evaluation of Medicinal Products.Accelerated evaluation of products indicated <strong>for</strong> seriousdiseases (life-threatening or heavily disabling diseases)(CPMP/495/96 rev. 1). <strong>European</strong> Agency <strong>for</strong> the Evaluation ofMedicinal Products London, 2001.7. <strong>European</strong> Medicines Agency. Available from http://www.emea.eu.int/home.htm.8. <strong>European</strong> Commission, Enterprise Directorate-General. Thenotice to applicants, vol. 2A, Procedures <strong>for</strong> MarketingAuthorisation. <strong>European</strong> Commission. Brussels 2002.9. Healy EM, Kaitin KI. The <strong>European</strong> Agency <strong>for</strong> the Evaluationof Medicinal Products’ Centralised Procedure <strong>for</strong> productapproval: current status. Drug Inf J 1999;33:969–78.10. Redmond K. The US and <strong>European</strong> regulatory systems: acomparison. J Ambul Care Manage 2004;27(2):105–14.11. Ericson M, Webster C, de Cremier F. Accelerated assessmentand temporary <strong>marketing</strong> authorisation in the <strong>European</strong><strong>Union</strong>. Regulatory Affairs Journal 2004;15(9):645–9.12. <strong>European</strong> Commission, Enterprise Directorate-General.Available from http://dg3.eudra.org/F2/register/orphreg.htm.13. Pignatti F, Boone H, Moulon I. Overview of the <strong>European</strong>regulatory approval system. J Ambul Care Manage2004;27(2):89–97.14. <strong>European</strong> Medicines Agency. Available from http://esubmission.eudra.org/pim.html.

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!