Rägo Lembit, Sillo Hiiti, 't Hoen Ellen, Zweygarth Monika
Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland.
Antivir Ther. 2014;19 Suppl 3:69-77. doi: 10.3851/IMP2902. Epub 2014 Oct 13.
Medicines of uncertain quality, safety and efficacy can be worse than no treatment at all. It is the responsibility of national medicines regulatory authorities to protect patients from harm. Yet, there are great disparities in regulatory capacity globally, preventing large populations from accessing the benefits of advances in the pharmaceutical field. This article describes the main regulatory functions and how they are applied to assure the quality, safety and efficacy of different types of medicines in different environments. It gives examples of initiatives that have increased access to good quality medicines worldwide and - more importantly - are laying the groundwork for collaborative approaches aiming to ensure that pharmaceutical products meet the same, stringent quality standards in all parts of the world.
质量、安全性和有效性存疑的药物可能比根本不治疗更糟糕。保护患者免受伤害是各国药品监管机构的责任。然而，全球监管能力存在巨大差异，这使得大量人口无法从制药领域的进步中受益。本文介绍了主要的监管职能以及它们如何应用于确保不同环境下各类药物的质量、安全性和有效性。文中列举了一些举措的实例，这些举措增加了全球优质药品的可及性，更重要的是，为旨在确保药品在世界各地都符合同样严格质量标准的合作方法奠定了基础。
