Regulatory policies on medicines for psychiatric disorders: is Europe on target?
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.
Barbui
Corrado
C
Garattini
Silvio
S
D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D011619:Psychotropic Drugs / Q000592:standards* / Q000627:therapeutic use
D011619:Psychotropic Drugs