Pignatti Francesco, Boone Hilde, Moulon Isabelle
European Agency for the Evaluation of Medicinal Products (EMEA), Canary Wharf, London, United Kingdom.
J Ambul Care Manage. 2004 Apr-Jun;27(2):89-97. doi: 10.1097/00004479-200404000-00003.
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.
欧洲药品法的主要目标是保障公众健康，同时鼓励制药行业的发展，并在欧盟创建一个单一的药品市场。在过去40年里，欧洲法律已确立并统一了欧盟药品生产、分销和使用监管的诸多方面。1995年迈出了重要一步，成立了欧洲药品评估局（European Medicines Evaluation Agency, EMEA）并建立了集中程序，从而对新药进行全欧盟范围的单一评估和批准。本文介绍了欧盟现有的药品批准体系以及未来提议的变革。
