Table I.

Summary of the Data Requirements for New Generic Drug Applications in Japan

Content of the data submitted for application		New drug	New generic drug
A. Origin or background of discovery and conditions of use in foreign countries	1. Origin or background of discovery	〇	×
	2. Conditions of use in foreign countries	〇	×
	3. Special characteristics, comparisons with other drugs, and related information	〇	×
B. Manufacturing methods, standards, and test methods	1. Chemical structure, physicochemical properties, and related information	〇	×
	2. Manufacturing methods	〇	△
	3. Specifications and test methods	〇	〇
C. Stability	1. Long-term storage tests	〇	×
	2. Tests under severe conditions	〇	×
	3. Accelerated tests	〇	〇
D. Pharmacological action	1. Primary pharmacology	〇	×
	2. Secondary pharmacology, safety pharmacology	〇	×
	3. Other pharmacology	〇	×
E. Absorption, distribution, metabolism, and excretion	1. Absorption	〇	×
	2. Distribution	〇	×
	3. Metabolism	〇	×
	4. Excretion	〇	×
	5. Bioequivalence	〇	〇
	6. Other ADME	〇	×
F. Acute, subacute, and chronic toxicity, teratogenicity, and other types of toxicity	1. Single-dose toxicity	〇	×
	2. Repeated dose toxicity	〇	×
	3. Genotoxicity	〇	×
	4. Carcinogenicity	〇	×
	5. Reproductive toxicity	〇	×
	6. Local irritation	〇	×
	7. Other toxicity	〇	×
G. Clinical studies	1. Clinical trial results	〇	×

In principle, 〇 means that the indicated data is required. × means that the indicated data is not required. △ indicates necessity of the indicated data is case based