Practical- 18 Date. 13/12/2023
Faculty of Pharmacy, Marwadi University
Aim: Comparative Study of DMF system in US, EU and Japan.
Sr. No.
Particulars
UNITED STATES
EUROPEAN
UNION
JAPAN
1.
Nomenclature
Drug Master File
Active Substance
Master File
Drug Substance
Manufacturing and
Control
Information
2.
Ownership
Drug substance
manufacturer
Drug product
manufacturer
(generally)
Either drug
substance or drug
product
manufacturer
(often API
supplier)
3.
Structure &
Content
Unstructured,
manufacturer
determines content
Defined format
with specific
modules for
different data
categories
Specific format,
but allows more
flexibility than EU
ASMF
4.
Submission &
Review
Voluntary, reviewed
only when
referenced in NDA
Mandatory for
centralized MAAs,
optional for
national MAAs
Voluntary,
encouraged for
imported drug
substances,
reviewed when
referenced in drug
application
5.
Fees &
Maintenance
Annual
maintenance fees,
no submission fees
No fees for
submission or
maintenance
No fees for
submission or
maintenance
6.
Impact on Global
Strategy
Flexibility, suitable
for global
Standardized
format simplifies
global submissions
Voluntary nature
offers flexibility
but may
