Marketing Authorizations of Medicinal Products in the European Union: Past, Present, and Future
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Drug Information J o u m l . Vol. 34. pp. 793-800, 2000 Printed i n the USA. All rights reserved.
MARKETING AUTHORIZATIONS OF MEDICINAL PRODUCTS IN THE EUROPEAN UNION: PAST, PRESENT, AND FUTURE GUENTER HENNINGS, PHD Vice-President, Global Regulatory Approval and Marketing Support Europellnternational Center, Aventis Pharma, Romainville, France
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 eflcacy. Remaining issues regarding the transparency of the evaluation, appeal, arbitration, and decision making process offer room f o r 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 Key Words: National and community systems for marketing authorizations; Centralized Procedure; Mutual Recognition Procedure; Regulatory environment in the European
Union
INTRODUCTION SINCE INCEPTION OF the basic European Directive 65/65 EEC, the regulatory environment for registration and marketing of medicinal products in the European Union (comprised today of Member States: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain, Sweden, and the United Kingdom) has changed considerably. Taking into account the complex-
Reprint address: Guenter Hennings, Aventis-Hoechst Marion Roussel, 102, route de Noisy, F-93235 Romainville cedex, France.
ity and magnitude of the task of creating a truly European marketing authorization process, we see real progress. Public health is the prerogative of each Member State. The definition of public health differs self-evidently from one Member State to the next because it is influenced by national historical backgrounds, medical cultures, pricing and reimbursement criteria, legal status of medicinal products, and the 11 official languages. Marketing authorizations of medicinal products are a part of this complex and changing environment. Since 1965, standards and requirements for product approval have been harmonized to some degree and the evaluation of quality, safety, and efficacy constitutes the only legal
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basis for granting marketing authorization. Community procedures for marketing authorizations and referrals are in place. The European Medicines Evaluation Agency (EMEA) was established. There are still areas that need impr
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