Analysis of Pediatric Drug Approval Lag in Japan
- PDF / 1,083,113 Bytes
- 10 Pages / 595.276 x 790.866 pts Page_size
- 17 Downloads / 208 Views
ORIGINAL RESEARCH
Analysis of Pediatric Drug Approval Lag in Japan Eiji Ueyama1,2 · Masayuki Kaneko1 · Mamoru Narukawa1 Received: 10 June 2020 / Accepted: 5 September 2020 © The Drug Information Association, Inc 2020
Abstract Background Drugs should be made available to all patients in a timely manner regardless of whether they are adults or children. In contrast to the United States (US) and the European Union (EU), no laws mandating pediatric drug development have been established in Japan. The objective of this study was to examine the current status and characteristics of pediatric drug development in Japan using information on the approval lag for pediatric indications between Japan and the EU. Methods Drugs approved for pediatric indications between January 2007 and December 2018 in Japan were studied. The approval lag for pediatric indications between Japan and the EU was calculated and analyzed by approval time and the Anatomical Therapeutic Chemical (ATC) classification. Factors potentially affecting the approval lag, such as orphan drug status, company nationality, and clinical data package, were examined. Results The median approval lag for 105 drugs with pediatric indications in both Japan and the EU was 1017 days (Japan was behind). The lag for ATC category B improved significantly after 2011, and for category L after 2015; the medians were less than half a year. The lag for drugs developed globally via multi-regional clinical trials was significantly shorter compared with drugs developed regionally. Conclusion Global clinical trials are the most effective means of shortening approval lag time in pediatric drug development. Global development is making rapid progress for many adult diseases, thereby creating an environment for proactive participation in global clinical trials even for pediatric drugs. For further improvement, more active drug development for pediatric indication is recommended in tandem with the US and the EU. Keywords Pediatric drug development · Regulatory science · Approval lag · Development strategy · Global clinical trial · Japan
Introduction Safe and effective drugs should ideally be made available to all patients worldwide in a timely manner following appropriate evaluation. However, in reality, there is a drug approval lag (hereafter “approval lag”) defined as the time difference in drug approval among different countries/ regions [1]. Approval lag has been recognized as a major issue in Japan, especially in the twenty-first century [2]. This issue is of significant importance in the context of * Eiji Ueyama [email protected] 1
Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5‑9‑1 Shirokane, Minato‑ku, Tokyo 108‑8641, Japan
Development, Astellas Pharma Inc., Tokyo, Japan
2
immediately life-threatening or serious conditions. Due to this reason, in 2007, the Ministry of Health, Labor and Welfare (MHLW) stressed on the necessity of promoting global clinical trials and introduced
Data Loading...
