Provisions for drug insert sheets and labels (CFDA) www.croxxmore.com

1. Provisions for Drug Insert Sheets and Labels
Provisions for Drug Insert Sheets and Labels
Chapter I General Provisions
Article 1 The Provisions are enacted with a view to regulating
drug insert sheets and labels in accordance with the Drug Administration
Law of the People’s Republic of China and the Regulations for
Implementation of the Drug Administration Law of the People’s Republic
of China.
Article 2 The insert sheets and labels of drugs marketed within
the territory of the People’s Republic of China shall meet the
requirements of the Provisions.
Article 3 Drug insert sheets and labels shall be reviewed and
approved by the State Food and Drug Administration.
A drug shall be labeled on the basis of its insert sheet. The content of
the label shall be within the scope of the insert sheet. Any words and
marks with implied therapeutic effects, misleading information on usage,
or inappropriate promotion of the product shall not be printed.
Article 4 A drug label shall be printed on or affixed to the drug
package, and no other written words, audio and/or visual materials or
other information are attached to introduce or publicize the product or
the enterprise.
An insert sheet shall be attached to the smallest package provided by the
drug manufacturer for marketing.
Article 5 The wording in drug insert sheets and labels shall be
scientific, standardized and accurate. The insert sheet of a
non-prescription drug shall be written intelligibly and convenient for
patients to judge, choose and use the drug on their own.
Article 6 In the label or insert sheet, the letters or characters
shall be clear and easy to be recognized and the marks shall be clear and
distinctive. The label and insert sheet shall have no print faded and shall

2. not be affixed unsteadily. Any addition or modification shall not be made
by means of pasting, cutting or altering.
Article 7 Drug insert sheets and labels shall be written in
standardized Chinese characters published by the National Language
Commission. The versions in other languages shall comply with the Chinese
version.
Article 8 With the aim to protect public health and direct the
rational use of drugs, drug manufacturers may voluntarily apply to add
warnings to drug insert sheets or labels. The State Food and Drug
Administration may also request drug manufacturers to add warnings to drug
insert sheets or labels.
Chapter
II Drug Insert Sheet
Article 9 A drug insert sheet shall include the significant
scientific data, conclusions and information concerning drug safety and
efficacy in order to direct the safe and rational use of drugs. The
specific format, content and writing requirements of drug insert sheet
shall be prescribed and issued by the State Food and Drug Administration.
Article 10 Disease names, pharmaceutical terms, drug names, the
names and results of clinical testing in drug insert sheets shall be
expressed in professional terms published or standardized by the State.
The units of measurement shall conform to the national standards.
Article 11 All the active ingredients or medicinal ingredients
of traditional Chinese medicines in a prescription shall be listed in the
insert sheet. For injections and non-prescription drugs, all excipients
shall be listed as well.
The ingredients or excipients included in a prescription, which may cause
severe adverse reaction, shall be specified.
Article 12 A drug manufacturer shall trace the safety and efficacy
of its marketed drugs. For any modification to the insert sheet, an
application shall be submitted timely.
The State Food and Drug Administration may also require a drug
manufacturer to make modification to the insert sheet on the basis of the
results of adverse drug reaction monitoring and drug re-evaluation.

3. Article 13 After the modification to the insert sheet is approved,
the drug manufacturer shall inform relevant drug distributors, drug users
and other departments of the modified content immediately, and use the
modified insert sheet and label timely as required.
Article 14 The insert sheet shall provide full information on
adverse drug reaction and indicate the adverse reactions in detail. A drug
manufacturer, who fails to timely modify the insert sheet on the basis
of the safety and efficacy data of the marketed drug or to fully explain
the adverse reaction in the insert sheet, shall be liable for all the
consequences arising therefrom.
Article 15 The approval date and the modification date shall be
distinctively shown in the insert sheet.
Chapter
III Drug Labels
Article 16 Drug labels refer to the information printed or pasted
on drug packaging, including inner labels and outer labels. Inner labels
refer to those that appear on immediate packaging; outer labels are those
on the other packaging outside of inner labels.
Article 17 The inner label shall bear such drug information as
the adopted name in China, indications or functions, strength, dose and
usage, production date, batch number, expiry date and manufacturer. If
there is no enough space in the package to include all the information
mentioned above, the adopted name in China, strength, batch number and
expiry date shall be indicated at least.
Article 18 The outer label of a drug shall indicate such
information as the adopted name in China, ingredients, description,
indications or functions, strength, dose and usage, adverse reactions,
contraindications, precautions, storage, production date, batch number,
expiry date, approval number and manufacturer. Where indications or
functions, dose and usage, adverse reactions, contraindications and
precautions cannot be fully noted, main information plus a “See drug
insert sheet for details.” notice shall be indicated.
Article 19 The label on the package for transportation and storage
shall bear at least the adopted name in China, strength, storage,
production date, batch number, expiry date, approval number and

4. manufacturer. Other information such as packaging quantity, precautions
for transportation or other marks may be included when necessary.
Article 20 The label for drug substance shall include the adopted
name in China, storage, production date, batch number, expiry date,
applied specifications, approval number and manufacturer. Other
necessary information such as packaging quantity and precautions for
transportation shall also be indicated.
Article 21 Where one drug produced by a manufacturer has the same
drug strength and packaging specification, the content, format and color
of its labels must be the same. Where one drug produced by a manufacturer
has different drug strengths or packaging specifications, its labels
shall be clearly distinguished from one another, or its specifications
shall be notably marked in the corresponding specification items.
Where a drug produced by a manufacturer is administrated as prescription
drug and non-prescription drug respectively, their packaging colors shall
be distinctly different.
Article 22 For drugs with special requirements on storage, its
requirements shall be marked in the notable place of the label.
Article 23 The expiry date in the drug label shall appear in the
order of year, month and day, with year shown in four digits, month and
day in two digits. Its specific format shall be “Valid till XXXX year
XX month” or “Valid till XXXX year XX month XX day”. It may be presented
with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till
XXXX/XX/XX”.
For the preventive biological product, the expiry date shall be labeled
according to the registration specifications approved by the State Food
and Drug Administration. The expiry date of the biological product for
therapeutic use shall be counted from the filling date. For other drugs,
the expiry date shall be counted from the production date.
Where the expiry date is labeled to the day, it shall be marked as one
day earlier than the actual expiry date; where the expiry date is labeled
to the month, it shall be marked as one month earlier than the actual expiry
month.
Chap
ter IV Use of Drug Name and Registered Trademark

5. Article 24 The drug name in insert sheets and labels shall conform
to the nomenclature principles on the adopted name in China and trade name
of drug announced by the State Food and Drug Administration, and shall
be consistent with those appeared in the approval documents of the drug.
Article 25 The adopted name in China shall be conspicuous and
prominent, and its typeface, size and color shall be consistent, and meet
the following requirements:
(1) For horizontal labels, the adopted name in China shall appear in a
prominent position within the area of the upper one-third of the label;
for vertical labels, it shall appear in a prominent position within the
area of the right one-third of the label;
(2) No such illegible typefaces as cursive characters and seal
characters shall be used, and no such format as italics, margining and
shading shall be used to modify the typefaces.
(3) The font color of the adopted name in China shall be black or white,
in sharp contrast to the light-colored or dark-colored background
respectively.
(4) Writing in separate lines shall be avoided unless limited by the
packaging size.
Article 26 The trade name of a drug shall not be placed in the
same line with the adopted name in China; its typeface and color shall
be no more conspicuous than that of the adopted name in China, and its
font area per character shall be no bigger than half of that of the adopted
name in China.
Article 27 Unregistered trademarks and other drug names
unapproved by the State Food and Drug Administration shall not be used
in the drug insert sheets and labels.
Where a registered trademark is used in a drug label, it shall be printed
in a corner of the label. Where a registered trademark contains characters,
the font area per character shall be no bigger than a quarter of that of
the adopted name in China.
Chapter
V Other Provisions
Article 28 For narcotic drugs, psychotropic substances,
medicinal toxic drugs, radioactive pharmaceuticals, drugs for topical use,
non-prescription drugs and other drugs having special marks specified by
the State, their special marks shall be printed in the drug insert sheets

6. and labels.
Where there are special provisions issued by the State for drug insert
sheets and labels, they shall prevail.
Article 29 The labeling provisions for Chinese crude drugs and
prepared slices of Chinese crude drugs shall be formulated separately by
the State Food and Drug Administration.
Article 30 Where drug insert sheets and labels are not in
compliance with the Provisions, a punishment shall be imposed in
accordance with the relevant provisions of the Drug Administration Law
of the People’s Republic of China.
Chapter VI Supplementary
Provisions
Article 31 These Provisions shall come into force as of June 1,
2006. the Provisions for Drug Packaging, Labels and Insert Sheets
(Provisional) issued by State Food and Drug Administration on October 15,
2000 shall be annulled therefrom.