新《药品管理法》施行下对药品经营企业执行GSP的影响及建议

The impact and suggestions of the implementation of GSP by pharmaceutical trading enterprises under the implementation of the new Drug Administration Law

目的:分析新《药品管理法》施行下对药品经营企业执行《药品经营质量管理规范》(Good Supply Practice,GSP)的影响。方法:以"最严谨的标准、最严格的监管"为切入点,分析新法对药品经营企业的要求,论证其对药品经营企业执行GSP的影响。结果:执行GSP是保证药品经营全过程持续符合法定要求的前提。结论:药品经营企业应端正思想,通过不断系统性地学习法律法规,充实对GSP条款的理解,为企业经营活动持续符合法定要求提供保障。

Objective:To analyze the impact of the implementation of the new Drug Administration Law on Good Supply Practice(GSP)by pharmaceutical trading enterprises.Methods:Taking the most rigorous standards and the most stringent supervision as the starting point,the requirements of new law for pharmaceutical trading enterprises are analyzed and its impact on the implementation of GSP by pharmaceutical trading enterprises is demonstrated.Results:The implementation of GSP is the premise of ensuring that the whole process of drug business continues to meet the legal requirements.Conclusion:Pharmaceutical trading enterprises should systematically correct their thoughts and study laws and regulations to enrich their understanding of GSP terms so as to provide guarantees for the continued compliance of their business activities with legal requirements.