Bertele' Vittorio, Li Bassi Luca
Laboratory Regulatory Policies, "Mario Negri" Institute for Pharmacological Research, Milan, Italy.
J Ambul Care Manage. 2004 Apr-Jun;27(2):98-104. doi: 10.1097/00004479-200404000-00004.
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.
欧洲药品评估局（EMEA）的成立使得欧盟15个成员国共享一个评估新药品的通用系统，这对制药行业和患者都具有重要意义，包括：（1）成员国在评估新药申请时节省的时间和精力；（2）欧盟国家药品供应更加一致和迅速；（3）在整个欧盟建立统一的监管政策。然而，EMEA“促进人类健康保护”的目标（理事会条例，1993年）与现行系统之间存在一些不一致之处。本文回顾了EMEA的组织和程序，并对现行系统提出了一些重大修改建议。
