Regulation and Safety Unit, World Health Organisation, Geneva, Switzerland.
Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Expert Rev Clin Pharmacol. 2021 Feb;14(2):173-177. doi: 10.1080/17512433.2021.1865798. Epub 2020 Dec 23.
: A survey was conducted among national regulatory authorities' members of the International Pharmaceutical Regulators Programme (IPRP) to collect and share experiences of reliance approaches. Reliance allows formally, or informally, one regulatory authority to use assessments made by other regulatory authorities while remaining responsible for the final decision. Reliance is an essential concept to increase the efficiency of the global regulatory oversight of medical products by national regulatory authorities.: This article describes the findings and recommendations from the IPRP survey. It shows that reliance in the area of medical product oversight is broadly accepted. The first part presents the acceptance and reasons for accepting reliance including the need for trust, then gives examples of the most common areas for reliance, and explains the difference between unilateral or reciprocal reliance. Finally, the article analyzes the lessons learned including challenges and opportunities for reliance on regulatory authorities to facilitate patient access in their jurisdictions.: Regulatory reliance facilitates regulatory approvals and allows to use resources in a more efficient way and ultimately serves patients by facilitating earlier access to quality-assured, safe, and effective medicines.
一项针对国际药品监管者协会（IPRP）成员国的监管机构成员的调查旨在收集和分享对依赖方法的经验。依赖是指一个监管机构正式或非正式地利用其他监管机构的评估结果，同时对最终决定负责。依赖是提高国家监管机构对药品全球监管效率的一个重要概念。本文描述了 IPRP 调查的结果和建议。它表明，在医疗产品监管领域，依赖得到了广泛的认可。第一部分介绍了接受和接受依赖的原因，包括对信任的需求，然后给出了依赖最常见的领域的例子，并解释了单边或双边依赖之间的区别。最后，本文分析了所学到的经验教训，包括对监管机构的依赖带来的挑战和机遇，以促进其管辖范围内的患者获得药物。监管依赖促进了监管批准，并允许更有效地利用资源，最终通过促进对质量保证、安全和有效的药物的早期获得来为患者服务。
