From the view of NHI coverage scope and speed, the hurdle to access new drugs in Japan is shown to be lower than in other countries that also set public prices for reimbursement. Although the difficulty of controlling health expenditures increases, drug pricing that properly reflects the drug's clinical value is important in that it also furthers the development of medical technology. Better price setting can also facilitate patient access to innovative drugs.

Predictability of future drug price is expected to be enhanced by the point-based system. As the control of health expenditure becomes strict, the importance of considering drug pricing policy that properly reflects the drug's clinical value increases.

From the viewpoint of the health insurance coverage proportion and the speed of reimbursement decision, the hurdle to access new drugs in Japan is lower than that in major European countries. While extensive coverage of health insurance and prompt reimbursement decision lower the hurdles to access new drugs and expand treatment options, they could lead to the increased medical expenditure. We should continue to discuss sustainable health insurance systems and drug price calculation schemes that properly reflect the drug's clinical value while keeping the availability of new drugs to patients.

1 ．背 景 日本では新薬へのアクセスの向上のため，海外で承認さ れた医薬品が日本で承認されるまでの時間差(ドラッグラ グ)の解消を課題として，さまざまな施策が行われてき た 1) ．その結果，新薬の審査期間は短縮されてきたが，いま だ新薬の多くは米国または欧州で先行して開発され，承認 されている 2) ．今後，世界で最初の承認国が日本となる医 薬品を増加させていくことは，新薬へのアクセスのさらな る向上のため重要な課題であると考える． それと並行して，今後新たに登場する医薬品について， そのリスク管理を適正に行っていくことも重要である．海 外で先行して承認された医薬品では，日本で承認されるま でに当該医薬品の実臨床での安全性情報が海外で集積さ れ，これらの情報を参考に市販後安全対策を立案し，実施 することが可能である．一方，世界で最初の承認国が日本 である医薬品または海外と同時期に日本で承認された医薬 品では，承認までに得られた情報に基づき市販後安全対策 を立案し，実施していくことが求められる． 本研究では，近年日本で承認された新薬について，その 承認が世界で最初のものであったか否かに着目し，その シーズ創出や開発に関する地域的な状況との関係を調査す るとともに， 承認時に特定された安全性検討事項を比較し， 新薬を世界に先駆けて日本で実用化するためのより良い開 発環境および市販後安全対策のあり方について検討するこ とを目的とした． 2 ．方 法 2. 1．研究対象品目の選定および分類2008 年 1 月から 2014 年 12 月の期間に日本で承認され た新有効成分含有医薬品(ワクチンおよび診断用医薬品を 臨床薬理 Jpn J Clin Pharmacol Ther 2017 ; 48(1): 9-14 9 ＊ 北里大学大学院薬学研究科臨床医学(医薬開発学) 著者連絡先：還田悠平 北里大学大学院薬学研究科臨床医学(医薬開発学) 〒 108-8641 東京都港区白金 5-9-1 detailed information including the regions where the new drugs were developed and the countries of first global approval were identified. We also collected information about safety concerns that were identified before approval.Result : Two hundred and thirty-nine NASs obtained Japanese approval during the study period. Of the 239 NASs, 44 (18.4％) were approved in Japan before the rest of the world. Drugs that obtained Japanese approval first in the world were more often developed in Japan from the early stage. Furthermore, the data suggested that these drugs were launched with relatively limited safety information.

Japan has one of the largest medical device markets in the world, but most devices used in Japan are pioneered by foreign medical device companies. On the other hand, medical device companies in Japan have significant potential to develop innovative medical devices. Through this research, we aim to elucidate the factors related to the total review time of new medical devices so that innovative medical devices would be developed sooner. Using the lists of approved medical devices disclosed by the Pharmaceuticals and Medical Devices Agency (PMDA), we chose all the new medical devices that were approved in Japan between Fiscal Year (FY) 2009 and 2015. We conducted two main types of analyses based on the total review time after submission and sales of the companies. The total review time tends to decrease with "Year of approval by the PMDA'' in FY 2009 to 2015 (p < 0.001). Moreover, the total review time of small and medium-sized companies is greater than that of large companies (p = 0.004). In conclusion, the total review time of new medical devices in Japan appears to be related to the following two factors: (1) year of approval, and (2) size of the enterprise.https://doi.org/10.21423/jrs-v06n02p024 (DOI assigned 1/24/2019)