Faich G A, Castle W, Bankowski Z
Council for International Organizations of Medical Sciences, c/o World Health Organization, Geneva, Switzerland.
Int J Clin Pharmacol Ther Toxicol. 1990 Apr;28(4):133-8.
A method for standardized postapproval adverse drug reaction (ADR) reporting has been developed and implemented by seven multinational pharmaceutical manufacturers and six regulatory authorities. This is based on a set of uniform definitions, procedures and a single reporting form, and has been demonstrated to be useful and effective. When regulators and manufacturers develop requirements and systems for ADR reporting they should consider adapting this method.
一种标准化的批准后药品不良反应（ADR）报告方法已由七家跨国制药商和六个监管机构开发并实施。该方法基于一套统一的定义、程序和单一报告表，已证明是有用且有效的。监管机构和制药商在制定ADR报告要求和系统时应考虑采用这种方法。
