PDF(Pubmed)
Abstract：
The pharmaceutical industry is vital for healthcare advancement through innovative medications, improving lives. A substantial challenge is \"Drug lag,\" hindering patient access and increasing disease adjusted life years burdens. We aim to examine drug lag for Iran Food and Drug Administration (IFDA) approved drugs versus US Food & Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) over 2001 to 2021. We reviewed new molecular entities within this period, using descriptive statistics in Excel 2019. Drug lag is assessed from relative and absolute perspectives, considering approval gaps and annual rates. Among 710 FDA-approved drugs, 410 received EMA approval, 344 from PMDA, and 148 from IFDA. For 148 IFDA and FDA-approved drugs, the maximum drug lag was 237 months. The mean relative drug lag was 65.18 ± 61.56 months. Compared to EMA (112 drugs), the maximum lag was 257 months, with a mean relative lag of 70.29 ± 53.67 months. With PMDA (127 drugs), the maximum lag was 253 months, with a mean relative lag of 38.23 ± 60.57 months. Iran faces significant drug lag compared to developed countries\' regulatory bodies, limiting patient access to innovative treatments. Addressing this issue is crucial for timely drug access, reducing disease burdens. Further research and policy interventions are needed to mitigate drug lag\'s impact on Iran healthcare landscape.
摘要：
制药行业通过创新药物对医疗保健发展至关重要，改善生活。一个重大挑战是“药物滞后，“阻碍患者进入和增加疾病调整寿命年负担。我们的目标是检查伊朗食品和药物管理局（IFDA）批准的药物与美国食品和药物管理局（FDA）的药物滞后，欧洲药品管理局（EMA）以及2001年至2021年的药品和医疗器械管理局（PMDA）。我们回顾了这段时间内的新分子实体，在Excel2019中使用描述性统计数据。药物滞后从相对和绝对角度进行评估，考虑批准差距和年率。在FDA批准的710种药物中，410获得EMA批准，344来自PMDA，和IFDA的148。对于148个IFDA和FDA批准的药物，最大药物滞后时间为237个月.平均相对药物滞后为65.18±61.56个月。与EMA（112种药物）相比，最大滞后时间为257个月,平均相对滞后70.29±53.67个月。PMDA（127种药物），最大滞后时间为253个月,平均相对滞后38.23±60.57个月。与发达国家的监管机构相比，伊朗面临严重的药物滞后，限制患者获得创新治疗。解决这个问题对于及时获得毒品至关重要，减轻疾病负担。需要进一步的研究和政策干预，以减轻药物滞后对伊朗医疗保健前景的影响。
