小结（Summary）

法律、法规、指令和指导文件的目的是保护人民的生命和健康。顾名思义，法律、法规、指令是要强制执行的，不执行者将要受到法律的制裁。指导文件则表达了监管机构对某些议题的建议、想法以及如何操作的具体措施。法律、法规、指令和指导文件是做好药物安全与药物警戒工作的保障。由于所在国家、地区的不同，各国各地的法律也有所不同。因此，当一个产品要在某个国家或地区上市，除了要执行药品生产国的法律法规外，还要执行当地监管部门的法令和要求，了解当地药品适应证靶向人群的基本情况，熟悉当地健康医疗系统的运作和实际情况，这些对药物安全风险管理在当地的实施十分重要。

Laws，regulations，directives，and guidance documents in drug safety and pharmacovigilance are designed to protect people's lives and health.In the US，laws are the mandatory requirements that are enforceable.Non-compliance has legal consequences.Regulations are based on and enforceable by law，non-compliance can have legal consequences.Guidelines provide guidance to assist in complying with the requirements（of laws and regulations）and are not binding or enforceable by law.The laws and requirements could be different due to different countries and areas.It is critical important to comply with all global and local laws，regulations for new drug applications.

（崔燕宁 陈晓瑜）