世界初承認医薬品の開発経緯およびリスクの特定状況に関する研究

抄録

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.