Pharmaceuticals

Submission Data for Clinical Trials

Toxicity Data Required for Pharmaceutical Marketing Authorization

New Drug New Derivative Drug New Drug New Combination Drug New Route of Administration Drug New Dosage Regimen Drug Innovative Drug New Formulation Drug Biological Products,
Recombinant DNA Products,
Cell Culture–Derived Products, etc.
Single dose toxicity ○ *
Repeated Dose Toxicity ○ *
Genetic toxicity ○ *
Developmental
/Reproductive
toxicity		 ○ *
Carcinogenicity *
Other toxicology *
Efficacy ○ ○ ○ ○ ○ *
Pharmacology ○ *
ADME Data ○ ○ *

○ : Data submission required
△ : Submission may be waived where submission is meaningless or impossible depending on the characteristics of the individual product
× : Data submission exempted
* : Determined according to the characteristics of the product