Analysis of Drug Lags and Designation Lags of Orphan Drugs Recently Approved in Japan
Regulatory Science of Medical Products
This study aims to understand the current situation and discuss elements that would further promote the development of orphan drugs in Japan. We analyzed drug lags(approval lags)and designation lags on orphan drugs approved as new drug categories in Japan over the past 5 years from 2010 to 2014. As a result, many of orphan drugs were developed in Japan after they were established in the US and the EU, and one-fourth at the maximum were developed locally for Japan. Regarding drugs that were
... approved in the US or the EU ahead of Japan, Japanese median drug lags behind the US and the EU(lags of drugs that were considered spontaneously developed by pharmaceutical companies are in parentheses)were 50.0(25.1)months and 34.8(20.4)months, respectively. While Japanese drug lag issue for new medicines has recently been resolved, it was revealed that a longer drug lag behind overseas still exists in orphan drugs field. Japanese median designation lags behind the US and the EU were 63.8(30.6)months and 46.7(30.0)months, respectively. With further analysis and consideration, the drug lag and the designation lag in Japan are considered significantly attributable to a lag in development initiation or application for orphan designation. We consider it necessary to discuss revision of the existing designation criteria, development fee grant system operational procedures, and provision of incentives, aiming resolution of a lag in development initiation or application for orphan designation and further promotion of orphan drug development in Japan.