Pharmaceutical Administration and Regulations in Japan - Nihs

Table 3 Data to be Submitted with an Application for Approval to
Manufacture/Market a New Prescription Drug (Attached Table 2-1 in PFSB Notification
No. 0304004 dated March 4, 2009)
(1) Prescription drugs with new
active ingredients
(2) New combination prescription
drugs
(3) Prescription drugs with new
administration routes
(4) Prescription drugs with new
indications
(5) Prescription drugs with new
dosage forms
(6) Prescription drugs with new
doses
A
1 2 3
B
1 2 3
C
1 2 3
D
1 2 3
E
1 2 3 4 5 6
○: Date required ×: Data not required ∆: Data required depending on individual cases
2011-3 - 125 -
F
1 2 3 4 5 6 7
○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ∆ ○ ○ ○ ○ × ∆ ○ ○ ○ ∆ ○ ∆ ∆ ○
○ ○ ○ × ○ ○ ○ ○ ○ ○ ∆ ∆ ○ ○ ○ ○ × ∆ ○ ○ × × × ∆ × ○
○ ○ ○ × ○ ○ ○ ○ ○ ○ ∆ ∆ ○ ○ ○ ○ × ∆ ○ ○ × ∆ ○ ∆ ∆ ○
○ ○ ○ × × × × × × ○ × × ∆ ∆ ∆ ∆ × ∆ × × × × × × × ○
○ ○ ○ × ○ ○ ○ ○ ○ × × × ○ ○ ○ ○ × ∆ × × × × × × × ○
○ ○ ○ × × × × × × ○ × × ○ ○ ○ ○ × ∆ × × × × × × × ○
(7) Similar biological drugs ○ ○ ○ ○ ○ ○ ○ ∆ ∆ ○ × × ∆ ∆ ∆ ∆ × ∆ ∆ ○ × × × ∆ ∆ ○
(8) Prescription drugs with
additional dosage forms
(during reexamination period)
(8-2) Same with (8) (not during
reexamination period)
(9) Combination prescription
drugs with similar formulations
(during reexamination period)
(9-2) Same with (9) (not during
re-examination period)
(10) Other prescription drugs
(during reexamination period)
(10-2) Same with (10) (changes
in manufacturing method of
biological products, etc.)
(10-3) Same with (10) (not during
reexamination period)
(10-4) Same with (10-3)
(changes in manufacturing
method of biological products,
etc.)
○ ○ ○ × ○ ○ ∆ ∆ ○ × × × × × × ×○ × × × × × × × × ×
○ ○ ○ × ○ ○ ○ ○ ○ ∆ ∆ × × × × × × × ○ ∆ × × × ∆ × ○
× × × × ∆ ○ × × ○ × × × × × × ×○ × × × × × × × × ×
G