Editorial
doi: 10.1192/bjp.bp.106.024794.
Regulatory policies on medicines for psychiatric disorders: is Europe on target?
- PMID: 17267922
- DOI: 10.1192/bjp.bp.106.024794
Item in Clipboard
Editorial
Regulatory policies on medicines for psychiatric disorders: is Europe on target?
Br J Psychiatry.
2007 Feb.
Abstract
The European Medicines Agency (EMEA) is the regulatory body that provides the institutions of the European Community with the best possible scientific advice on the quality, safety and efficacy of medicinal products. Drugs approved by the EMEA are automatically marketable in all the European member states. Since the beginning of the EMEA's activities a number of drugs acting on the central nervous system obtained marketing authorisation. This editorial highlights some aspects of the EMEA rules that may negatively affect the evaluation of medicines for psychiatric disorders.
Similar articles
-
Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.Eur J Clin Pharmacol. 2002 Nov;58(8):495-500. doi: 10.1007/s00228-002-0511-0. Epub 2002 Sep 25. Eur J Clin Pharmacol. 2002. PMID: 12451425
-
[Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Apr;48(4):423-8. doi: 10.1007/s00103-005-1022-9. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005. PMID: 15830253 German.
-
Typical pitfalls in applications for marketing authorization of biotechnological products in Europe.Nat Rev Drug Discov. 2008 Nov;7(11):893-9. doi: 10.1038/nrd2728. Nat Rev Drug Discov. 2008. PMID: 18974748 Review.
-
Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years.Eur J Clin Pharmacol. 2006 Nov;62(11):947-52. doi: 10.1007/s00228-006-0193-0. Epub 2006 Oct 5. Eur J Clin Pharmacol. 2006. PMID: 17021892
-
[A systemic review of the European Agency for the evaluation of medicinal products (EMEA) recommendations on the conduct of clinical trials in psychiatry].Epidemiol Psichiatr Soc. 2002 Jan-Mar;11(1):28-34. doi: 10.1017/s1121189x00010125. Epidemiol Psichiatr Soc. 2002. PMID: 12043431 Italian.
Cited by
-
Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.Nat Rev Drug Discov. 2010 Apr;9(4):277-91. doi: 10.1038/nrd3079. Epub 2010 Feb 26. Nat Rev Drug Discov. 2010. PMID: 20186141 Review.
-
Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response.Nat Rev Drug Discov. 2011 Jul 1;10(7):495-506. doi: 10.1038/nrd3501. Nat Rev Drug Discov. 2011. PMID: 21720406 Review.
-
EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations.Epidemiol Psychiatr Sci. 2021 Apr 30;30:e35. doi: 10.1017/S2045796021000147. Epidemiol Psychiatr Sci. 2021. PMID: 33926608 Free PMC article.
-
Does the development of new medicinal products in the European Union address global and regional health concerns?Popul Health Metr. 2010 Dec 20;8:34. doi: 10.1186/1478-7954-8-34. Popul Health Metr. 2010. PMID: 21172012 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical
