Publications

Research Paper Series 2006

(No.33:August 2006)

Conditional approval and post marketing study
- Analysis of new drugs approved between 2000 and 2005 -

Mikio Sasabayashi and Orie Asaka

[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.

[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 Medical Devices Agency.

[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, number of new drugs approved with conditions such as all case surveillance, which impose considerable burden on pharmaceutical companies, are growing [Figure 1].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 in approval reviews.How to strike a balance between post marketing safety measures and acceleration of new drug development is a subject of future investigation. 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.

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