RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Quality & Compliance: Japan’s Drug Lag and National Agenda

Quality & Compliance: Japan’s Drug Lag and National Agenda

Posted 01 January 2011 | By Eriko Tsukamoto, MBASatish Tripathi, PhD

Since 1999, a drug called Doxil has been used in 75 countries as the standard treatment for recurrent ovarian cancer. In Japan, however, patients waited nearly 10 years before Doxil received approval and became listed in April 2009. This case is merely one example of how Japan's drug approval lag is adversely affecting its patients, who do not have access to medicines that are marketed in the rest of the world. Japanese patients sometimes must wait for a marketed drug to be approved for a new indication, and at other times they must wait for a drug to become available at all. Drug lag impacts drugs developed in Japan and those developed in other countries and marketed in Japan.


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.