Department of Pharmacoeconomics and Pharmaceutical Administration, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran.
Department of Pharmacoeconomics and Pharmaceutical Administration, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Medicine (Baltimore). 2024 Jun 21;103(25):e38142. doi: 10.1097/MD.0000000000038142.
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.
制药行业通过创新药物为医疗保健的进步做出了重要贡献，改善了人们的生活。一个重大挑战是“药品滞后”，这阻碍了患者的获得药物的机会，并增加了疾病调整生命年的负担。我们旨在研究 2001 年至 2021 年期间，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)、欧洲药品管理局 (EMA) 和药品和医疗器械管理局 (PMDA) 之间的药品滞后情况。我们在这一期间内审查了新的分子实体，并在 Excel 2019 中使用描述性统计数据。从相对和绝对的角度评估药品滞后，考虑批准差距和年度速度。在 710 种获得 FDA 批准的药物中，有 410 种获得了 EMA 的批准，有 344 种获得了 PMDA 的批准，有 148 种获得了 IFDA 的批准。对于 148 种 IFDA 和 FDA 批准的药物，最大的药品滞后时间为 237 个月。平均相对药品滞后时间为 65.18±61.56 个月。与 EMA（112 种药物）相比，最大滞后时间为 257 个月，平均相对滞后时间为 70.29±53.67 个月。与 PMDA（127 种药物）相比，最大滞后时间为 253 个月，平均相对滞后时间为 38.23±60.57 个月。与发达国家的监管机构相比，伊朗面临着严重的药品滞后问题，限制了患者获得创新治疗的机会。解决这个问题对于及时获得药物、减轻疾病负担至关重要。需要进一步的研究和政策干预来减轻药品滞后对伊朗医疗保健领域的影响。
