KDMF Regulations - Apec-ahc.org

KDMF KDMF Regulations
Regulations
Regulations Regulations
Contents
Contents
The The The Enforcement Enforcement Regulation of
the the Pharmaceutical Affairs Affairs Act
clause clause 3, 3, 3, Article Article Article 26 26
26
The The Enforcement Enforcement Regulation Regulation of
the the Pharmaceutical Affairs Act,
Article Article 3( 3(Manufacturer 3( Manufacturer obligations obligations) obligations
)
No. No. No. 15
The The Enforcement Enforcement Regulation Regulation of of
the the Pharmaceutical Affairs Affairs Act,
Article Article 43(Manufacturer
3(Manufacturer Obligations Obligations) Obligations
)
No. No. 16
Guidance Guidance for Drug Master Master Files
(Announced (Announced (Announced by by the the KFDA KFDA) KFDA
Anyone Anyone who who intends intends to to manufacture manufacture or or import import
import
designated designated drug drug substances substances should should submit submit DMF
DMF
application application Form Form and and data data to to the the KFDA KFDA Commissioner
Commissioner
Commissioner
A A drug drug manufacturer can can only use drug substances
publicly publicly announced announced by by the the KFDA KFDA Commissioner
Commissioner
Commissioner
A A DMF DMF holder holder must must notify any changes of DMF data
to to the the KFDA KFDA Commissioner Commissioner by by the the end end of of January January
January
every every year
year
List List of of designated designated drug drug substance, substance, substance, data preparatio preparatio
method, method, extent extent and and requirements requirements of of data, data, KDMF
KDMF
process process flow
flow
Designated Designated Drug Drug Substances
Substances
1. Active ingredients of New drug (since Jul 1, 02)
2. Human placenta- derived drug substance
3. Drug substances specified by KFDA
123 ingredients 141 ingredients(Jan 1, 11)
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2