Postmarketing Clinical Research as a Condition for Approval A Survey of Products Approved in 2000-2005
Mikio Sasabayashi (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Orie Azumi (Former Senior Researcher, Pharmaceuticals and Industrial Policy Research Institute)
(No.33: Published in August 2006)
A survey was conducted on the status of granting conditions of approval for new drugs and drugs containing new active ingredients approved in Japan from 2000 to 2005. The survey results indicate that the number of new drugs subject to post-marketing surveillance, clinical trials, etc. as conditions of approval is on the rise. 50% of the new active ingredient-containing drugs approved between 2003 and 2005 were subject to conditions of approval. In addition, the clinical development period for items with approval conditions tended to be shorter than that for items without approval conditions, and the time gap between the world's first market launch and the Japanese market launch was also shorter for items with approval conditions. Although the causal relationship is not clear, the results suggest that there is a relationship between the availability of overseas data and the presence or absence of approval conditions.
One issue for future consideration is how to take measures that strike a balance between strengthening post-marketing safety measures and development incentives. It is also worth considering the establishment of a mechanism to avoid prolonged development periods through the flexible use of conditional approval.