2021年1月23日发(作者：weekend)
Administrative Regulation for Insert and packaging Labels of drug
(SFDA Order No.24)

State Food and Drug Administration Order
No.24

“
Administrative Regulation for Insert and packaging Labels of Drug
”
had been evaluated & agreed
by
the
management
meeting
of
SFDA
by
Mar.10,
2006,
and
publish
here,
the
same
to
be
implemented since June 1
st
, 2006.





Administrative Regulation for the Insert and Packaging Labels of Drug

Section I

No.1
For standardizing the administration for the insert and packaging labels of drug on the basis
of “Drug Administration law of
the P. R. of
China” and “
Regulations for Implementation of
the Drug Administration Law of the P. R. of China”.

No.2
Relevant inserts and packaging labels for all the drugs which are sold in china to be in line
with the requirements from present regulation.
No.3
The Inserts and packaging labels of drugs should be approved by SFDA.
The packaging labels of drugs to be drafted as per the insert, their text should not exceed the
range of insert, and should not contain the character and mark which suggests the efficacy,
mislead uses and unsuitable publicity the product.
General rules












SFDA Director: Shao Ming Li


Mar. 15, 2006

1
No.4
The label should be printed or stickled on the package for drug as per relevant regulations,
and can
’
t carry any other character, audiovisual, or material for introduction or publication
propaganda for product and / or manufacturer.

The
smallest
pack
sold
in
market
from
the
pharmaceutical
manufacturer
should
contain
insert.
No.5
The text expression for drug
’
s insert and labels should be scientific, standard and accurate.
The text
expression for
the insert
for OTC drug should be
easy
for understanding for the
patients whom could be able to self judges, selects and uses.
No.6
The text of drug
’
s insert and labels should be clear and easy to be differentiated, the mark
should be clear and striking, the appearance with dropping words or unstick etc. should not
appear, and can't be modified or supplemented by sticking, cutting or altering.
No.7
The
standard
Ch.
Character
published
by
State
Spoken
and
Written
Language
Committee
should be used for the insert
and labels
of drug, the Ch. Character expression will be the
criterion when has additional other language for reference.
No.8
For the purpose of protecting the public health and guiding the drug to be used by a right
and rational way, the pharmaceutical manufacturer may raises forwardly to add the warnings
on the drug
’
s insert or labels, SFDA also may require relevant pharmaceutical manufacturer
to add the warnings on the insert or labels.

Section II
Drug
’
s insert

No.9
Drug
’
s insert should contain the important and scientific data, results and information about
the safety and efficacy of drug, so that can be able to guide the safe and rational uses of drug.
The detail format, contents and written requirement for drug
’
s insert are drafted and issued
by SFDA.
No.10
The expression of the disease names, pharmaceutical specialized nouns, drug name, clinical
test names and results in the drug
’
s insert should use the special and standard vocabulary or
that one issued by state, and the weights and measures to be in line with the requirements of
national standard.

2
No.11
All the APIs or crude drugs in the formula to be listed in the drug
’
s insert. All the excipients
for the injection and OTC drugs are also to be listed in the insert.

That
’
s to
be indicated if the formula
contains the ingredient(s) or
excipient(s) which may
cause a serious adverse reaction.
No.12
The
pharmaceutical
manufacturer
should
track
forwardly
the
safety
and
efficacy
status
of
drug
post
market,
and
should
raise
the
application
in
time
for
the
modification
of
drug
’
s
insert if necessary.

According to the monitor results for the adverse reactions of drug and the re-evaluation of
drug, SFDA also may require the pharmaceutical manufacturer to modify the drug
’
s insert.
No.13
The
pharmaceutical
manufacturer
should
inform
the
modified
contents
to
relevant
pharmaceutical business companies, used units and the concerned depts. immediately after
the modified insert was approved, and implement the modified insert and labels in time as
per the requirements.
No.14
Drug
’
s insert should contain enough information of adverse reactions of drug, and indicate
the
adverse
reactions
in
detail.
If
the
pharmaceutical
manufacturer
had
not
modified
the
insert
in
time
on
the
basis
of
the
safety
and
efficacy
status
of
drug
post
market
or
didn
’
t
indicate enough the adverse reactions of drug in the insert, the harmful result caused to be
borne by relevant manufacturer.
No.15
The approval date and revised date of drug
’
s insert to be indicated clearly in the insert.

Section III

No.16
The labels of drug refer to the contents which are printed or pasted in the package of drug, it
divides
into
internal
label
or
outer
label.
The
internal
label
refers
to
that
label
used
for
immediate pack, and the outer label refers to that labels used for other packs except internal
label.
No.17
The
internal
label
of
drug
should
contain
the
contents
of
generic
name,
indications
or
efficacy,
strength,
dosage
and
administration
of
drug,
mfg
date,
batch
No.
expiry
date,
manufacturer etc.

3
Labels of drug