Pharmaceutical Administration and Regulations in Japan - Nihs

(Table 3) Drug classification system
(1) “Prescription drugs with new active ingredients” refer to drugs that have ingredients never before been used as active
ingredients in drugs that have already been approved for manufacture/marketing or are specified in the Japanese
Pharmacopoeia (“approved drugs, etc.” hereinafter).
(2) “New combination prescription drugs” refer to drugs with different active ingredients or combining ratios from those of
combination drugs specified in the Japanese Pharmacopoeia or combination drugs that have already been approved for
manufacture/marketing as prescription drugs. However, combination prescription drugs with similar formulations specified in (8)
and drugs such as digestive enzyme combination drugs and mild acting poultices that are judged not to be new from an overall
evaluation are excluded.
(3) “Prescription drugs with new administration routes” refer to dugs that have the same active ingredients as approved drugs,
etc. but have different routes of administration (oral, subcutaneous, intramuscular, intravenous, percutaneous, per-rectal,
transvaginal, eye drops, nasal drops, inhalation, etc.).
(4) “Prescription drugs with new indications” refer to drugs that have the same active ingredients and routes of administration as
approved drugs, etc. but have different indications.
(5) “Prescription drugs with new dosage forms” refer to drugs that have the same active ingredients, routes of administration and
indications as approved drugs, etc. but have new dosage forms with different administration, etc. because of pharmaceutical
changes such as sustained release. However, drugs with additional dosage forms specified in (7) are excluded.
(6) “Prescription drugs with new doses” refer to drugs that have the same active ingredients and routes of administration as
approved drugs, etc. but have different doses.
(7) “Biosimilar products” refer to biotechnological products equivalent to existing (approved) biotechnological products in quality
(8) “Prescription drugs with additional dosage forms” refer to drugs that have the same active ingredients, routes of
administration, indications and dosage and administration as approved drugs, etc., but have different dosage forms or contents.
(9) “Combination prescription drugs with similar formulations” refer to prescription drugs with active ingredients and combining
ratios that are judged to be similar to those of combination drugs specified in the Japanese Pharmacopoeia or combination drugs
that have already been approved for manufacture/marketing as prescription drugs.
(10) “Other prescription drugs” refer to biological products such as vaccines and blood products entered in the Biological Product
Standards; recombinant DNA drugs, cell culture drugs and other drugs applying biotechnology or drugs derived from living
organisms.
a. Origin or background of
discovery, conditions of use in
foreign countries
b. Manufacturing methods,
standards and test methods
c. Stability
d. Pharmacological action
e. Absorption, distribution,
metabolism, and excretion
f. Acute, subacute, and chronic
toxicity, teratogenicity, and other
types of toxicity
g. Clinical studies
1. Origin or background of discovery
2. Conditions of use in foreign countries
3. Special characteristics, comparisons with other drugs, etc.
1. Chemical structure and physicochemical properties, etc.
2. Manufacturing methods 3. Standards and test methods
1. Long-term storage tests 2. Tests under severe conditions (stress tests)
3. Accelerated tests
1. Tests to support efficacy 2. Secondary pharmacology, Safety pharmacology
3. Other pharmacology
1. Absorption 2. Distribution 3. Metabolism
4. Excretion 5. Bioequivalence 6. Other pharmacokinetics
1. Single dose toxicity 2. Repeated dose toxicity
3. Genotoxicity 4. Carcinogenicity 5. Reproductive toxicity
6. Local irritation
Clinical trial results
7. Other toxicity
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