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Learning from the report of the independent medicines and medical devices safety review: "first do no harm".从独立药品和医疗器械安全审查报告中汲取经验:“首要之务,勿伤患者” 。
Scott Med J. 2022 Feb;67(1):2-6. doi: 10.1177/00369330211058467. Epub 2022 Jan 7.
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Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature.因药物不良反应导致462种药品上市后撤市:对世界文献的系统评价
BMC Med. 2016 Feb 4;14:10. doi: 10.1186/s12916-016-0553-2.
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Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview.欧盟关于人用药品临床试验的第536/2014号法规概述。
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THE INTERNATIONAL CONTROL OF DRUGS OF ADDICTION: The Present Position of the International Opium Convention, 1912.国际成瘾药物管制:1912年《国际鸦片公约》的现状
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PARLIAMENTARY COMMITTEE ON PROPRIETARY MEDICINES.专利药品议会委员会
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6
[Regulation (EC) No. 1394/2007 on advanced therapy medicinal products : Incorporation into national law].[关于高级治疗用医药产品的(欧盟)第1394/2007号法规:纳入国内法]
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Benoxaprofen.苯恶洛芬
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Cold comfort for hot children.给发热儿童的寒心慰藉。
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The Apothecaries Act, 1815: a reinterpretation.1815年《药剂师法案》:一种重新解读
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Chlorodyne dependence.氯仿精依赖
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英国 1500-2020 年的药品立法和监管。

Medicines legislation and regulation in the United Kingdom 1500-2020.

机构信息

School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.

West Midlands Centre for Adverse Drug Reactions, City Hospital, Birmingham, UK.

出版信息

Br J Clin Pharmacol. 2023 Jan;89(1):80-92. doi: 10.1111/bcp.15497. Epub 2022 Sep 23.

DOI:10.1111/bcp.15497
PMID:35976677
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10087031/
Abstract

The initial purposes of regulation of medicines in England, and latterly in the United Kingdom, were principally to raise government revenue, to discourage murder by poisoning and to regulate the activities of pharmacists. It was only much later that regulators sought to ensure that medicines were of good quality, reasonably safe, and at least somewhat effective, and to curtail misuse of drugs. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics.

摘要

在英国,药品监管的最初目的主要是为了增加政府收入、遏制投毒谋杀行为以及规范药剂师的活动。直到后来,监管机构才开始寻求确保药品质量良好、相对安全、至少有一定疗效,并遏制药物滥用。在此,我们从对治疗学感兴趣的临床医生的角度来审视英国药品和毒药监管的历史。