Marketing Authorizations of Medicinal Products in the European Union: Past,Present,and Future

Abstract

Since 1965, a continuous process of standardization and harmonization of regulatory requirements has been in motion to improve the marketing authorization systems within the European Union. In this context, the establishment of the European Medicines Evaluation Agency and the enactment of community procedures (centralized and decentralized procedures) represent the latest developments toward review of medicinal products on the basis of quality, safety, and efficacy. Remaining issues regarding the transparency of the evaluation, appeal, arbitration, and decision making process offer room for further improvements in the coming decade. As the European Union braces itself for the future entry of new Member States, this requirement to improve becomes a crucial factor in the maintenance of a viable system of marketing authorizations for medicinal products; it is essential in permitting the safe and effective use of medicinal products for the European customer.