Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care giúp cho các bạn có thêm kiến thức về ngành y học đề tài: Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations. | Child and Adolescent Psychiatry and Mental Health BioMed Central Open Access Review Regulation EC No 1901 2006 on medicinal products for paediatric use clinical research in vulnerable populations Birka Lehmann Address Bundesinstitut fur Arzneimittel und Medizinprodukte Kurt-Georg-Kiesinger Allee 3 53175 Bonn Germany Email Birka Lehmann - blehmann@ Published 8 December 2008 Received 28 July 2008 Child and Adolescent Psychiatry and Mental Health 2008 2 37 doi 1753-2000-2-37 Accepted 8 December 2008 This article is available from http content 2 1 37 2008 Lehmann licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http licenses by which permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited. Abstract Before any medicinal product is authorised for use in adults it must undergo extensive pharmaceutical consistency and stability tests toxicological tests and clinical trials to ensure that it is of high quality safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50 of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products off-label and to use unauthorised products with the associated risks of inefficacy and or adverse reactions. The Regulation EC No 1901 2006 sets up a system of requirements rewards and incentives together with horizontal measures to ensure that medicinal products are researched developed and authorised to meet the therapeutic needs of children. .
