Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency

Jan Regnstrom (1) , Franz Koenig (1) , Bo Aronsson (1) , Tatiana Reimer (1) , Kristian Svendsen (1) , Stelios Tsigkos (1) , Bruno Flamion (1) , Hans-Georg Eichler (1) , Spiros Vamvakas (1)

1 European Medicines Agency (EMEA)

Mots clés: Drug approval; Drug development; Regulatory; Scientific advice

Jan Regnstrom, Franz Koenig, Bo Aronsson, Tatiana Reimer, Kristian Svendsen, et al.. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. European Journal of Clinical Pharmacology, 2009, 66 (1), pp.39-48. ⟨10.1007/s00228-009-0756-y⟩. ⟨hal-00537993⟩