2015 Fiscal Year Final Research Report
Assessment of regulatory efforts to facilitate the approval of off-label drugs
| Project/Area Number |
24590619
|
|---|
| Research Category |
Grant-in-Aid for Scientific Research (C)
|
| Allocation Type | Multi-year Fund |
|---|
| Section | 一般 |
|---|
| Research Field |
Medical sociology
|
|---|
| Research Institution | Tokai University (2015)
Osaka University (2014)
Kyushu University (2013)
Nagasaki University (2012) |
|---|
Principal Investigator |
|
|---|
| Co-Investigator(Kenkyū-buntansha) |
IKEDA Masayuki 香川大学, 医学部, 客員研究員 (10242215)
|
|---|
| Project Period (FY) |
2012-04-01 – 2016-03-31
|
| Keywords | レギュラトリーサイエンス / 適応外使用 / 公知申請 / コンペンディウム / コンパニオン診断 / CBRN対策 |
|---|
| Outline of Final Research Achievements |
This study sought to investigate the factors that contribute to the approval of individual applications through an analysis of review reports and to assess the outcome of efforts to facilitate the approval of off-label drugs by the public knowledge approval system that has been used for over a decade in Japan. Prior approval by foreign authorities, although important, did not appear to be essential for approval in Japan. Substantiating safety and effectiveness of agents by means of standard textbooks or guidelines was used consistently to obtain approval for off-label use. In addition, we investigated the relation between evidence and approval relating to companion diagnostics and medical countermeasures against chemical, biological, radiological and nuclear (CBRN) agents in Japan.
|
| Free Research Field |
医薬品評価科学
|
