A Comprehensive Analysis of Factors That Contribute to Conditional Approval and All-Case Surveillance Designations That Subsequently Lead to Shortening of Review Times in Japan
A Comprehensive Analysis of Factors That Contribute to Conditional Approval and All-Case Surveillance Designations That Subsequently Lead to Shortening of Review Times in Japan
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综合分析有助于有条件批准和所有案件监视指定的因素，从而缩短日本的审查时间
DOI：
10.21423/jrs-v04n01p001
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发表时间：
2016
影响因子：
--
通讯作者：
Takeshi Suzuki
中科院分区：
文献类型：
--
作者：
Shoyo Shibata;Ryotaro Uemura;K. Chiba;Takeshi Suzuki
我们检查了2000年至2014年在日本调查的新分子实体的有条件批准和所有病例监测指定。使用单变量或多变量逻辑回归分析，本研究试图阐明影响这些指定接收的概况，并为有效使用有条件批准和所有病例监测指定提供指导。分析表明，应用这些系统的药物数量最多的是解剖学治疗学化学分类系统的L类（"抗过敏剂和免疫调节剂"）。孤儿药认定（ODD）和L药物与获得有条件批准和所有病例监测显著相关。这些指定缩短了审查时间。缩短审查期的积极因素包括ODD、使用全球数据和加入全球研究。桥接策略是唯一的负面因素。使用这种日本特定的PMS系统可以缩短药物滞后，从而确保日本www.example.com的安全性（DOI分配于2019年7月23日）
We examined conditional approval and all-case surveillance designations for new molecular entities investigated between 2000 and 2014 in Japan. Using univariate or multivariate logistic-regression analysis, this study attempted to clarify profiles that affect the receipt of these designations, and to provide guidance for effectively using conditional approval and all-case surveillance designations. Analysis showed that the highest number of drugs to which these systems were applied was category L (“Antineoplastic and immunomodulating agents”) of the Anatomical Therapeutic Chemical Classification System. Orphan drug designation (ODD) and L drugs were significantly correlated with the receipt of both conditional approval and all-case surveillance. These designations shortened the review time. Positive factors that shortened the period of review included ODD, using global data, and joining a global study. Bridging strategy was the only negative factor. Utilization of this Japan-specific PMS system can shorten drug lag, thereby securing the safety of Japanese subjects.https://doi.org/10.21423/jrs-v04n01p001 (DOI assigned 7/23/2019)