Drug Ther Bull. 1994 Dec 15;32(12):89-90. doi: 10.1136/dtb.1994.321289.
Since September 1971 the Medicines Act has provided the legal basis for controlling the manufacture, sale, supply and marketing of medicines in the UK. The law has been modified by Parliament and the incorporation of European directives, but until now its interpretation and implementation have remained matters for UK authorities. From 1 January 1995 the position changes with the establishment of the European Medicines Evaluation Agency (EMEA) and the introduction of marketing arrangements for medicines that will be binding across the European Union (EU). The EMEA, which will be based in London, will act as a coordinating centre, housing and servicing the Committee for Proprietary Medicinal Products (CPMP; equivalent to our Committee on Safety of Medicines), the body that will advise the European licensing authority (European Commission). The new arrangements will cover medicines and vaccines (including blood products and radiopharmaceuticals) for both human and veterinary use. This article outlines the workings of the new system and discusses how they might affect the provision of medicines for human use in the UK.
自1971年9月起，《药品法》为英国药品的生产、销售、供应及营销管控提供了法律依据。该法律已由议会修订，并纳入了欧洲指令，但迄今为止，其解释与实施仍由英国当局负责。自1995年1月1日起，随着欧洲药品评估局（EMEA）的设立以及适用于整个欧盟（EU）的药品上市安排的引入，情况发生了变化。总部位于伦敦的EMEA将作为协调中心，为专利药品委员会（CPMP，相当于我们的药品安全委员会）提供办公场所并提供服务，该委员会将为欧洲药品许可机构（欧盟委员会）提供建议。新的安排将涵盖用于人类和兽医学的药品及疫苗（包括血液制品和放射性药物）。本文概述了新系统的运作方式，并讨论了其可能对英国人类用药供应产生的影响。
