Overview of the European regulatory approval system.
The primary aim of European pharmaceutical law is to safeguard public health, while encouraging the development of the pharmaceutical industry and the creation of a single market for pharmaceuticals in the European Union (EU). Over the last 40 years, European law has established and harmonized many aspects of regulating the production, distribution, and use of medicines in the EU. A major step was taken in 1995 with the creation of the European agency for the evaluation of medicinal products (European Medicines Evaluation Agency, EMEA) and the establishment of a centralized procedure, leading to a single EU-wide evaluation and approval of new medicines. This article presents the available systems for drug approval in the EU together with the changes proposed for the future.
Pignatti
Francesco
F
European Agency for the Evaluation of Medicinal Products (EMEA), Canary Wharf, London, United Kingdom. francesco.pignatti@emea.eu.int
Boone
Hilde
H
Moulon
Isabelle
I
D003695:Delivery of Health Care; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016527:Drug Costs; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D011634:Public Health