Principles and Practice of Pharmaceutical Medicine

Data required for a New Drug
Application (NDA)

According to Notification 481 from the PMSB,
dated 8 April 1999, the whole original list of data
required for a NDA should include from April
2000:

(a) Data on origin, details of discovery, use in
foreign country and so on:

1. Data on origin and details of discovery.


2. Data on use in foreign countries.


3. Data on characteristics and comparison
   with other drugs.

(b) Data on physical and chemical properties,
specifications, testing methods and so on:

1. Data on determination of structure.


2. Data on physical and chemical properties,
   and so on.
   3. Data on specifications and testing methods
   (standards).

(c) Data on stability:

1. Data on long-term storage test.


2. Data on severe test.


3. Data on acceleration test.

(d) Data on acute toxicity, sub-acute toxicity,

chronic toxicity, teratogenicity and other toxi-

city studies in animals:

1. Data on single dose.


2. Data on repeated dose.


3. Data on mutagenicity.


4. Data on carcinogenicity.


5. Data on reproduction.

Drugs

Ethical drugs

New drugs

· New active ingredients

· New combination

· New administration routes

· New indications

· New formulations

· New dosages

· Combination with similar formulations

· Additional formulation

· Other

· New active ingredients

· Active ingredients used for

the 1st time in non-prescription drugs

· Not covered by approval standards

· Different indications and

effects than approved drugs

· Of the same type as new non-prescription

drugs after PMS

· Formulations not in the approval

standards or special formulations

· With approval standards and others drugs

Other than new drugs

Non-prescription

new drugs

Others

Non-prescription drugs

Figure 35.4 Classification of drugs, function of the data to apply

494 CH35 JAPANESE REGULATIONS