Psychopharmacology at the era of EMEA (European Medicines Agency)
© Pestana and Gananca; licensee BioMed Central Ltd. 2009
Published: 22 April 2010
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.
This article is published under license to BioMed Central Ltd.