Abstract：
Drug repurposing has emerged as a promising approach in the drug discovery and development process as it offers safe and effective therapeutic options in a time effective manner. Though the issues related to pre-clinical and clinical aspects of drug development process are greatly addressed during drug repurposing yet regulatory perspectives gain even more However, like traditional drug development the repurposed drugs face multiple challenges. Such challenges range from the patenting rights, novelty of repurposing, data and market exclusivity to affordability and equitable access to the patient population. In order to optimize the market access of repurposed drugs, regulatory organizations throughout the world have developed accelerated approval procedures. The regulatory bodies have recognized the importance of repurposing approaches and repurposed drugs. Regulatory bodies can encourage the development of repurposed drugs by providing incentives to pharmaceutical companies and more accessible and affordable repurposed agents for the general population. This chapter summarizes the regulatory and ethical considerations pertaining to the repurposed drugs and highlights a few cases of intellectual property rights for repurposed drugs that have helped improve patient\'s access to safe, efficacious and cost-effective therapeutic options.
摘要：
药物再利用已成为药物发现和开发过程中的一种有希望的方法，因为它以时间有效的方式提供了安全有效的治疗选择。虽然与药物开发过程的临床前和临床方面有关的问题在药物再利用期间得到了很大的解决，但监管观点获得了更多的收益。像传统的药物开发一样，重新利用的药物面临着多重挑战。这些挑战包括专利权、重新利用的新颖性，数据和市场排他性对患者人群的负担能力和公平访问。为了优化再利用药品的市场准入,世界各地的监管组织都制定了加速审批程序。监管机构已经认识到重新利用方法和重新利用药物的重要性。监管机构可以通过向制药公司提供激励措施来鼓励再利用药物的开发，并为普通民众提供更容易获得和负担得起的再利用药物。本章总结了与再利用药物相关的监管和道德考虑因素，并重点介绍了一些有助于改善患者获得安全、有效和具有成本效益的治疗选择。
