Skip to main content

Psychopharmacology at the era of EMEA (European Medicines Agency)

In the last decade the European Medicines Agency has been attempting to harmonize the work of the existing national medicines regulatory authorities and the data regarding efficacy criteria and safety for the use of human medicines in specific pathologies (eg. Schizophrenia, Bipolar Disorder, Depression), thus creating guidance notes for clinical investigation. Medical prescription decisions are generally made upon data acquired through scientific information (treatise, studies, consensus, meetings, congresses), specialists experience and pharmaceutical industry information. While prescription rules are established for approved indications by large scale studies, off-label prescribing lacks the support of robust clinical trials and is at its best based on expert consensus. It brings with it increased responsibility for the prescriber if the patient suffered an adverse reaction, as liability would rest with the prescriber and/or their employers. Nuclear information for a rational plan, risk assessment, scientific evidence for add-on therapy and off-label prescription, will be discussed in this presentation.

Author information



Corresponding author

Correspondence to Licinia Gananca.

Rights and permissions

Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Pestana, L.C., Gananca, L. Psychopharmacology at the era of EMEA (European Medicines Agency). Ann Gen Psychiatry 9, S73 (2010).

Download citation


  • Schizophrenia
  • Bipolar Disorder
  • Medical Prescription
  • European Medicine Agency
  • Expert Consensus