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References

  • 1
    Garattini S, Bertele V. Europe's opportunity to open up drug regulation. BMJ 2010; 340: c1578.
  • 2
    European Medicines Agency. More transparency needed. Lancet 2010; 375: 1753.
  • 3
    Asamoah AK, Sharfstein JM. Transparency at the Food and Drug Administration. N Engl J Med 2010; 362: 23412343.
  • 4
    Eichler H, Aronsson B, Abadie E, Salmonson T. New drug approval success rate in Europe in 2009. Nat Rev Drug Discov 2010; 9: 355356.
  • 5
    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 establishing a European Medicines Agency.
  • 6
    Reflection paper: publication of withdrawals of marketing authorisation applications for human medicinal products. London, 5 October 2006. Doc. Ref. EMEA/239350/2005 Rev.1.
  • 7
    Plan for implementation of the pharmacovigilance legislation by the European Medicines Agency Activities to protect and promote public health 2012 in partnership with European Member States. EMA/64750/2012. 2 February 2012.
  • 8
    European Medicines Agency announces plan to publish committee agendas and minutes. EMA/480386/2012 Press release, 18 July 2012.
  • 9
    Pignatti F, Aronsson B, Gate N, Vamvakas S, Wade G, Moulon I, Le Courtois P. The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome. Eur J Clin Pharmacol 2002; 58: 573580.