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.
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。
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