The rising costs of new medicinal products are a challenge to the economic sustainability of national healthcare systems in ensuring patients’ access to therapies. European Union (EU) and US legislators have provided regulatory pathways aimed at simplifying Marketing Authorization (MA) applications for new medicinal products in cases when safety and efficacy profiles can be derived from the data of already-marketed products. In this review, we discuss the different regulatory pathways towards the MA of new medicinal products containing old drug substances and intended to improve the therapeutic value of a treatment, to obtain a new therapeutic indication (drug repositioning), or to ensure the same therapeutic value of a reference product at lower costs.

新医药产品成本的上升对国家医疗保健系统在确保患者获得治疗方面的经济可持续性构成了挑战。欧盟 (EU) 和美国立法者提供了监管途径，旨在简化新医药产品的上市许可 (MA) 申请，以防安全性和有效性特征可以从已上市产品的数据中得出。在这篇综述中，我们讨论了对含有旧药物的新药进行 MA 的不同监管途径，旨在提高治疗的治疗价值，获得新的治疗适应症（药物重新定位），或确保相同的治疗价值参考产品的低成本。