Conditional approval and post marketing study Analysis of new drugs approved between 2000 and 2005
Mikio Sasabayashi and Orie Asaka
No.33 : August 2006
Background
The importance of post-marketing study is growing in association with increased attention to the safety of new drugs. Simultaneously, the development time of new drugs has been getting longer in recent years. There is a need for a solution to shorten development time from the viewpoint of patient's access to valuable new drugs. Simultaneously, the development time of new drugs has been getting longer in recent years.
Methods
In this study, the status of conditional approval was investigated for new drugs and new molecular entities (NME) approved between 2000 and 2005. Status and content of conditions were surveyed using review reports or information on package inserts disclosed at the website of the Pharmaceuticals and The number of new drugs requiring a post
Results
The number of new drugs requiring a post-marketing study as an approval condition is increasing. 50% of the NME approved in the last three years were conditional. In particular, the number of new drugs approved with conditions such as all case surveillance, which impose considerable burden on Compared to the NME without conditions, clinical development time [Figure 2] and time lag between the first launch on a global level and launch Compared to the NME without conditions, clinical development time [Figure 2] and time lag between the first launch on a global level and launch in Japan were shorter for the NME with conditions.
Discussion
Behind the increase of conditional approvals, there is an environmental change surrounding new drug development, including enhanced post marketing safety measures and increased use of foreign data. Behind the increase of conditional approvals, there is an environmental change surrounding new drug development, including enhanced post marketing safety measures and increased use of foreign data in approval reviews. It would be reasonable to develop a scheme that applies conditional approval flexibly in order to reduce the development time of new drugs. Transparent dialogue among the parties will be recommended to reach consensus regarding requirement for applying conditional approval and contents of conditions. Transparent dialogue among the parties will be recommended to reach consensus regarding the requirement for applying conditional approval and contents of conditions.