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

@article{Regnstrom2009FactorsAW,
  title={Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency},
  author={Jan Regnstrom and Franz Koenig and Bo Aronsson and Tatiana Reimer and Kristian Svendsen and Stelios Tsigkos and Bruno Flamion and H G Eichler and Spiros Vamvakas},
  journal={European Journal of Clinical Pharmacology},
  year={2009},
  volume={66},
  pages={39-48}
}
To identify factors associated with success of Market Authorisation Applications (MAAs) for pharmaceutical drugs submitted to the European Medicines Agency (EMEA), with an emphasis on the Scientific Advice (SA) given by the Committee for Human Medicinal Products (CHMP). MAAs with a CHMP decision (outcome) between 1 January 2004 and 31 December 2007 were included in the analysis. Factors evaluated were: company size, orphan drug (OD) status, product type, existence of SA, compliance with SA… CONTINUE READING

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