A critique to the European regulatory system.
The establishment of the European Medicines Evaluation Agency (EMEA) has resulted in 15 states of the European Union (EU) sharing a common system for the evaluation of new medicinal products, with important implications for both industry and patients including (1) the time and effort saved by member states in the evaluation of new drug applications; (2) more consistent and quicker availability of medicines in EU countries; and (3) the establishment of a homogeneous regulatory policy throughout the EU. However, there are some inconsistencies between the EMEA objective "to promote the protection of human health" (Council Regulation, 1993) and the current system. This article reviews the organization and procedures of the EMEA and makes some proposals for substantial modifications to the present system.
Bertele'
Vittorio
V
Laboratory Regulatory Policies, "Mario Negri" Institute for Pharmacological Research, Milan, Italy. bertele@marionegri.it
Li Bassi
Luca
L
D003362:Cost-Benefit Analysis; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D015397:Program Evaluation; D011640:Public Policy