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

Shoyo Shibata, Ryotaro Uemura, Koji Chiba, Takeshi Suzuki


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)


drug development; all-case surveillance; conditional approval; regulatory review time; drug lag; PMDA

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