Avrupa İlaç Ajansı, şizofreni tedavisine yönelik olarak geliştirilen tıbbi ürünlerle ilgili olarak ilaç firmaları için hazırlamış olduğu rehberi güncelledi. (İng)
European Medicines Agency releases guideline on medicinal products for the treatment of schizophrenia
October 9th, 2012
The European Medicines Agency has updated its guidance for pharmaceutical companies developing medicinal products for the treatment of schizophrenia.
Published today, the guideline on clinical investigation of medicinal products, including depot preparations, in the treatment of schizophrenia, updates the previous document from 1995.
The guideline has been developed during a transitional period in which the DSM IV classification and diagnostic criteria for schizophrenia (and other psychotic conditions) are being revised in the preparation for DSM 5.
The guideline describes the main requirements for the development of medicinal products for the treatment of schizophrenia with regard to study design, patient population and outcome measures. Specific issues such as treatment-resistant patient populations and other specific patients groups (children and adolescents) are also addressed.
Attention is focused on alternative treatment options such as add-on, augmentation, and combination therapy. In addition, the importance of specific domains in schizophrenia including cognition and negative symptoms are discussed.
The guideline was adopted by the Committee for Medicinal Products for Human Use on 20 September 2012 after incorporation of comments from the public consultation phase.
The guideline comes into effect on 1 April 2013.