著者

還田 悠平 髙山 茜 成川 衛

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.48, no.1, pp.9-14, 2017-01-31 (Released:2017-02-17)

参考文献数

13

被引用文献数

1 1

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Background: In Japan, delay in marketing approval of new drugs, known as “drug lag”, was believed to hinder patient access to innovative treatments. The Japanese government took several corrective measures, and the median review time for new drugs was shortened. However, in many cases, new drugs are developed in the United States (US) and European Union (EU) , and these drugs are usually approved first in the US and EU prior to approval in Japan. Increase of drugs approved in Japan before the rest of the world or simultaneous with other countries is expected to further improve patient access to innovative drugs.Method: For all New Active Substances (NASs)that were approved in Japan between January 2008 and December 2014 , 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. Conclusion: For better patient access to new drugs, it is important to facilitate early development of new drugs in Japan and at the same time to ensure further strengthening of post-marketing safety measures.

著者

還田 悠平 髙山 茜 成川 衛

出版者

一般社団法人 日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.48, no.1, pp.9-14, 2017

被引用文献数

1

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<p><b>Background</b>: In Japan, delay in marketing approval of new drugs, known as &ldquo;drug lag&rdquo;, was believed to hinder patient access to innovative treatments. The Japanese government took several corrective measures, and the median review time for new drugs was shortened. However, in many cases, new drugs are developed in the United States (US) and European Union (EU) , and these drugs are usually approved first in the US and EU prior to approval in Japan. Increase of drugs approved in Japan before the rest of the world or simultaneous with other countries is expected to further improve patient access to innovative drugs.</p><p><b>Method</b>: For all New Active Substances (NASs)that were approved in Japan between January 2008 and December 2014 , 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.</p><p><b>Result</b>: 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.</p><p></p><b>Conclusion</b>: For better patient access to new drugs, it is important to facilitate early development of new drugs in Japan and at the same time to ensure further strengthening of post-marketing safety measures.

著者

盛岡 一輝 髙山 茜 成川 衛

出版者

一般社団法人 レギュラトリーサイエンス学会

雑誌

レギュラトリーサイエンス学会誌 (ISSN:21857113)

巻号頁・発行日

vol.7, no.3, pp.151-162, 2017 (Released:2017-09-30)

参考文献数

25

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本研究では, 我が国で現在もなお臨床現場で活用されている古くからある医薬品に着目し, 臨床上の有用性および利便性の観点からその特性を分析した. 1999年以前に我が国で承認され, 2013年国内売上高100億円以上の医療用医薬品を 「ロングセラー医薬品」 と定義し, 併せて, 各ロングセラー医薬品の競合品を2013年時点で製造販売されていた医薬品から選出した. 2013年国内売上高100億円以上であった154医薬品のうち, 58医薬品 (38%) がロングセラー医薬品であった. ロングセラー医薬品では, その競合品に比べて, 適応症に係る治療ガイドラインで第一選択として推奨される作用機序をもつ医薬品の占める割合が大きかった. また, 作用機序が同一の医薬品群における検討では, ロングセラー医薬品の添付文書には, その競合品の添付文書に比べて豊富な臨床成績が記載されており, さらに, 競合品に比べて適応症に係る治療ガイドラインで引用された市販後臨床成績をもつ医薬品の占める割合が大きかった. また, ロングセラー医薬品の1日投与回数は, その競合品の1日投与回数に比べて少なかった. 豊富な臨床上の有用性に係るエビデンスを有し, 新薬に比べて相対的に安価なロングセラー医薬品の活用は, 質の高い効率的な医療の提供および医療費の適正化の面から重要と考える.