|
KMID : 0986720200280010035
|
|
Korean Journal of Medicine and Law
2020 Volume.28 No. 1 p.35 ~ p.56
|
|
|
Responsibility for indemnification by exercising the discretion of the regulatory in New Drug Application
|
|
Park Jee-Hye
Bae Hyun-Ah
|
|
|
Abstract
|
|
|
|
This paper would discuss about the missing of key criteria for evaluating the safety of drugs in ?Regulation on Safety of Pharmaceuticals,etc?,?Regulation on Approval for Investigational New Drug Application of Drugs?, ?Regulation on Approval and Review of Biological Products? (Regulatory legislational omission); the defective administrative action and the revocation of new drug approval by the defective administrative action. And we would like to deal with the scope of discretionary exercise by the regulatory administration and the extent to which the liability for damages resulting from deviations of discretion to be recognized. Specifically, according to analyze the ‘Invosa-K inj’ Affair and compare law system between South Korea and United State of America, we will review the responsibility for damages resulting from deviations of discretion.
|
|
|
KEYWORD
|
|
|
Drugs, New Drug Application, Defective administrative action, Responsibility of indemnification, deviation of discretion, Regualtory legislational omission
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|