Guidelines for Writing the Package Insert of Traditional Chinese Medicine and Natural Drug Products

March 18, 2004

 Guidelines for Writing the Package Insert of Traditional Chinese Medicine and Natural Drug Products

I. Overview
A drug package insert is a document prepared and distributed by pharmaceutical manufacturers to physicians and patients, containing all critical information related to the use of the medication. It primarily includes essential scientific data and conclusions regarding the drug's safety and efficacy, along with other relevant details. The National Medical Products Administration (NMPA) approves the package insert based on the application materials submitted by the applicant. Pharmaceutical manufacturers are responsible for the accuracy and correctness of the package insert and must monitor the safety and efficacy of the drug post-marketing. If necessary, they should promptly submit an application to amend the package insert. The package insert serves as a primary tool for guiding rational clinical medication use by physicians and patients. It is a key technical resource for drugs, one of the main vehicles for conveying research findings and conclusions, and a fundamental basis for ensuring rational clinical medication. Consequently, countries worldwide regulate package inserts through legislation, imposing strict requirements and standards for their content. China has established corresponding regulations and guidelines for drug package inserts, issuing various regulatory documents to standardize their preparation. However, most existing regulations focus on general formatting and structural requirements rather than providing specific technical guidelines for drafting inserts based on drug research outcomes and conclusions. To address this gap, this guidance principle—titled "Guidance Principles for the Preparation of Package Inserts for Traditional Chinese Medicine and Natural Drug Products" (hereinafter referred to as "this Guidance Principle")—has been developed by referencing the principles and technical requirements adopted in developed countries, while taking into account the unique characteristics of traditional Chinese medicine currently practiced in China.

This guideline outlines the fundamental technical requirements for drafting and writing drug labeling based on findings and conclusions from pharmaceutical, pharmacological, and clinical studies.
This guideline is based on the "Detailed Rules for Traditional Chinese Medicine Drug Labels" (hereinafter referred to as the "Management Regulations"), published by the Registration Division of the State Food and Drug Administration in the draft "Regulations on the Administration of Drug Instructions and Labels." It primarily includes sections such as [Drug Name], [Ingredients], [Indications], [Dosage and Administration], [Adverse Reactions], [Contraindications], and [Precautions].
This guidance document is intended to assist pharmaceutical manufacturers in drafting and writing package inserts based on research findings and conclusions from pharmaceutical, pharmacological, and clinical studies. It also serves as a technical guideline for drug evaluation authorities when reviewing package insert submissions along with other relevant information.
    II. Basic Content Included in Instructions for Chinese Medicines and Natural Drugs
The basic content of the Instructions for Use for Traditional Chinese Medicine and Natural Drugs includes: Warning Statement, [Drug Name], Generic Name, Pinyin Name, [Ingredients], [Description], [Indications] (or [Therapeutic Indications]), [Dosage and Administration], [Adverse Reactions], [Contraindications], [Precautions], [Use in Pregnant or Nursing Women], [Use in Children], [Use in Elderly Patients], [Drug Interactions], [Clinical Studies], [Pharmacology and Toxicology], [Pharmacokinetics], [Specification], [Storage], [Packaging], [Shelf Life], [Approval Number], [Manufacturer], Enterprise Name, Production Address, Postal Code, Telephone Number, Fax Number, Website, [References], and [Publication Date].
General drug labels must include the following information: drug name, ingredients, indications or therapeutic functions, dosage and administration, adverse reactions, contraindications, precautions, specifications, expiration date, approval number, and manufacturer.

The drug label must also include sections on use in pregnant or breastfeeding women and drug-drug interactions. If reliable experimental data or literature is unavailable, the section title should be retained with the note "Undetermined."
The package insert shall also include sections on clinical studies, pediatric use, geriatric use, and drug overdose, as well as pharmacology/toxicology and pharmacokinetics. If a section cannot be included due to lack of reliable experimental or literature-based evidence, that heading shall be omitted from the insert.
If certain sections are not applicable, they may be omitted from the instructions without retaining their headings. For example: "Use in Pediatrics" for drugs intended for elderly patients; "Use in Pregnancy and Lactation" for medications intended for male patients.
   III. Basic Requirements for Drafting Instructions for Traditional Chinese Medicine and Natural Drugs
The package insert is a critical technical document for medicines and serves as the primary tool to guide clinicians and patients in rational drug use. Therefore, its preparation must adhere to the following basic requirements:
(1) The package insert must include a summary of critical information necessary for safe and effective use. This information shall be objective, accurate, free from promotional, false, or misleading language, and derived, to the extent possible, from reliable human clinical studies or applications.
(2) Must include all known and necessary information about the drug, especially indications, dosage and administration, adverse reactions, precautions, and other relevant details.
(3) Since public understanding of medicines evolves over time—encompassing both pre-market research and post-market monitoring—their labeling must be updated promptly as knowledge advances, rather than remaining static.
(4) Drug package inserts must use standardized Chinese characters published by the State Language Commission. Drug manufacturers may optionally include foreign languages or ethnic minority scripts for reference as needed.
(5) Drug package insert text shall be standardized, accurate, concise, and clear.
(VI) The terms used for diseases, pharmaceutical terminology, drug names, clinical test names, and results in the instructions for use shall conform to the standardized vocabulary issued by national authorities. Units of measurement shall comply with national standards.

   IV. Principles for Drafting Sections of Traditional Chinese Medicine and Natural Drug Labels
User Manual Title
"XXX" in "XXX Instructions" refers to the generic name of this medication.
(1) Warning
If applicable, this information must be clearly indicated in bold black text directly below the manual title and enclosed within a black border.
This section must describe serious adverse reactions, potential risks, usage restrictions, and actions to take if a serious adverse reaction occurs. If there is reasonable evidence linking a risk to the drug's use, the label must be updated to include this warning. Special circumstances, particularly those that may lead to death or serious injury, must be highlighted in a prominent boxed warning. Boxed warnings are typically based on clinical data; in the absence of clinical data, severe toxicity findings from animal studies may be used. An exclamation mark must precede the box, and the title "WARNING" must appear in bold within the box to emphasize the importance of the information. If the boxed warning contains extensive details about risks, full information should be provided in bold typeface in the relevant sections of the package insert (e.g., "Contraindications" or "Precautions"). The boxed warning must reference where detailed information can be found. Warning statements must not imply or suggest promotional claims about the product's benefits, nor should they indirectly promote other products.
Generally, consider the following aspects:
Important restrictions.
Severe adverse reactions observed in clinical practice.
Important medication precautions, such as warnings against abrupt discontinuation and guidance on drug interactions.
For compound preparations of Chinese and Western medicines, the chemical drugs that require special explanation should be indicated.
Formulations containing highly toxic drugs or incompatible combinations.
Other issues requiring special explanation.
(2) [Drug Name]
Generic Name: The generic name refers to the Chinese name listed in the national drug standards. It complies with naming principles for traditional Chinese medicine, and dosage forms must follow pharmacopoeia specifications (e.g., "soft capsule" instead of "gelatin capsule").

Pinyin: Determined based on the Pinyin of the drug's generic name, consistent with the Pinyin in the drug quality standard.
(3) [Ingredients]
This section refers to the herbs, active parts, or active ingredients contained in the prescription. The names of the herbs or ingredients used must match the standardized names listed under [Prescription] in the preparation quality standards. To serve public health interests and enable patients to fully understand the characteristics of the medication, all prescription components should be disclosed. If a component within a compound formula is itself a legally recognized compound formula preparation, only the name of the compound formula needs to be listed; the specific constituent herbs do not need to be itemized. For example, the [Ingredients] for Shan Zha Mai Qu Granules are Shan Zha (Crataegus), Mai Ya (Malt), and Qian Qu. Here, Qian Qu is a legally recognized compound formula preparation (Ministry Standard, Volume 2), composed of 24 herbs including Guang Huo Xiang, Lai Fu Zi, La Liao, Qing Hao, etc.; thus, listing "Qian Qu" alone in the [Ingredients] section is sufficient. However, if a component is a compound formula that is not a legally recognized standard preparation, its name cannot be listed as a single entry. Instead, the individual herbs comprising it must be specified in the [Ingredients] section. For instance, in the main ingredients of Shuang Long Feng Shi Die Da Gao, the Shuang Long Feng Shi Die Da Fluid Extract should be represented by its constituent herbs: Shuang Yan Long, Liang Mian Zhen, San Cha Ku, Niu Da Li, Shan Gui Hua, etc.
For herbs in prescriptions that belong to nationally banned or discontinued categories (e.g., tiger bone, rhino horn, Aristolochia manshuriensis), use the actual materials supplied in accordance with the relevant provisions of the discontinuation notice.
For the ordering of prescription ingredients in Chinese patent medicines, the arrangement must align with the traditional "monarch, minister, assistant, guide" (Jun-Chen-Zuo-Shi) principle and correspond to the indicated functions and therapeutic effects. For compound preparations containing both Chinese and Western medicines, all Western medicine components must be listed, with Chinese ingredients appearing before Western ones. For products already included in current national standards: - If the formulation or its modified dosage form has an officially published ingredient sequence by the National Medical Products Administration (NMPA), follow that sequence. - If the prescription contains more than 12 ingredients, only the first 12 ingredients need to be explicitly listed; remaining ingredients or components should follow in order of their primary-to-secondary contribution to the therapeutic effect. Injectable formulations must list all ingredients, including excipients. Excipients should appear after the active medicinal components.
(IV) [Appearance]
Write in accordance with national drug standards.
(5) Indications and Usage
This is one of the most critical sections in the package insert, covering the drug's indications or therapeutic uses.
1. Function: As an applicant for a traditional Chinese medicine (TCM) preparation, the function description must be standardized based on the prescription composition, TCM theory, and clinical research findings. The terminology should generally align with conventional TCM expression practices.
2. Indications for Use:
Except for drug varieties exempt from clinical studies as specified in the "Drug Registration Management Measures," the indications listed in the package insert of general drugs must be supported by sufficient evidence of efficacy, derived from well-controlled and rigorous clinical trials. The indication should be phrased using terms such as "indicated for" or "for treatment of." For traditional Chinese medicine (TCM) preparations, the indications should generally include descriptions of corresponding TCM syndromes or pathogenesis mechanisms.
Or specify. For diseases with clear Traditional Chinese Medicine (TCM) and Western Medicine diagnoses, the appropriate terminology for both should be determined based on clinical research findings. However, when using TCM disease terms, care should be taken to ensure conceptual clarity; avoid obscure or potentially misleading terms and disease names. To facilitate clinical guidance on medication use, descriptions should also include relevant symptoms and signs. For Chinese herbal preparations, standardize the presentation of TCM disease names, Western disease names, TCM syndromes, and associated clinical symptoms and signs across both systems. Clearly distinguish between indications for treating a disease, alleviating or reducing its symptoms, providing adjunctive therapy, or as part of combination therapy. Also, describe the specific therapeutic characteristics of the product, such as whether it is intended to relieve acute exacerbations or reduce the frequency of episodes. Additionally, provide details on the severity and stage of the applicable disease based on the specifics of the clinical study to fully reflect the study conditions.
Natural medicines are typically described using [Indications], which should be based on clinical research findings and may omit Traditional Chinese Medicine terminology.
Do not imply or suggest indications or uses (clinical applications) in other parts of the manual that are not included under this heading.

(VI) 【Usage and Dosage】
This section of the instructions must describe the recommended dosage and administration based on clinical trial results.
1. Usage
This section should be both detailed and highly readable, with clear operational guidance. It must explicitly and comprehensively outline the clinical administration methods for the medication, covering the following aspects:

Route of administration: e.g., oral, topical, intramuscular injection.
Administration: Swallow with hot water, steep in hot water, or take by holding in the mouth.
Herbal Medicine Consideration: As a traditional Chinese medicine, certain formulations may require a "medicinal guide" (yǐn), such as taking the herb with ginger and scallion broth.
Pre-administration drug preparation: Describe in detail based on clinical practice, especially for less common methods, injectables, topical agents, and other special formulations. Provide explicit instructions for dilution, compounding, handling, and dose division prior to use to avoid misinterpretation. Note that the route of administration, method of administration, and pre-administration preparation steps are often described together (e.g., sublingual administration).
Acupoint Drug Delivery: A unique method of administering Traditional Chinese Medicine that requires specifying the principles for selecting acupoints.
Some medications, particularly topical agents, certain gynecologic drugs, and injectables, require administration by healthcare professionals or physicians with specific expertise. This requirement must be clearly stated in the Instructions for Use section. For injectable solutions that require reconstitution or dilution prior to intravenous infusion, this section should also include critical information such as: dilution and preparation methods, recommended solvents, final concentration, volume of solvent used, storage conditions necessary to maintain stability of the drug or prepared solution, and appropriate rates for injection or infusion.
Additionally, dosage regimens may vary by indication and age group. Please ensure these distinctions are clearly stated in the usage instructions.
2. Usage
This section must specify the clinically recommended dosage or common dosage range, dosing interval, etc., based on clinical trial results. It may also include dosage and administration methods, typical treatment duration, and dosage adjustments for special patient populations, if supported by clinical study data. If no relevant studies were conducted, this information should not be included.
Accurately list the dosage, administration method, frequency, and duration of treatment, paying special attention to the relationship between the dosage and the formulation strength. Dosage should generally be expressed as "×× (or ××–××) tablets/capsules/ampoules/packs per dose, × (or ××–××) times daily." Do not use formats such as "×× (or ××–××)/dose, × (or ×–×) times/day," and do not use English letters to represent "daily." For special usage instructions, provide an accurate description based on clinical study findings. All instances of "××" must be represented using Arabic numerals.
If multiple specifications exist, in addition to stating the specification before the dosage, include the weight or volume unit (e.g., g, mg, ml) in parentheses after each count of tablets, capsules, vials, packets, etc., to avoid confusion. If the dose per unit is measured by active ingredients, components, or marker compounds (e.g., total saponins from Panax notoginseng, flavonoids from Erigeron), the content of such components may be used instead. This can be indicated in parentheses following the specification.
If the drug is an injection, lyophilized powder for injection, or a formulation made from active ingredients, the dosage must be expressed in weight or volume units. For example: "One dose ×× (or ××–××) [e.g., g, mg, ml]. To facilitate understanding and administration, specifications such as "×× vials" or "×× tablets" may be added in parentheses following the weight or volume unit."
Some medications require a loading dose followed by a maintenance dose, or should be started at a low dose and gradually increased to determine the appropriate dosage for the patient. Others must be taken before or after meals. These details must be clearly explained.
For drugs requiring a treatment course, the dosage, administration method, and duration must be clearly specified. If the dosage is calculated based on body weight or body surface area, it may follow the same approach used for chemical drugs, described according to clinical study data.

(VII) [Adverse Reactions]
Under this section, provide a detailed and factual list of all adverse reactions that may occur with the use of the drug. Any adverse events that cannot be excluded as unrelated to drug administration should also be documented here.
Adverse reactions listed may be categorized by organ system, severity, frequency, toxicological mechanism, or a combination thereof. If incidence rates from rigorous clinical studies are available, categorization and listing of adverse reactions should follow descending order of frequency. Within each category, more severe reactions should appear first. In the absence of such data, categorization and listing should follow descending order of severity.
(VIII) [Prohibited]
This section of the labeling must describe contraindications—situations where the known risks of using the drug clearly outweigh any potential therapeutic benefit. These include: use in patients with a history of severe hypersensitivity to the drug; use in certain patient populations (due to age, sex, concomitant therapy, disease state, Traditional Chinese Medicine pattern, or constitution) where the drug poses significant harm; or when unacceptable severe adverse reactions occur.
All potential harms that have been observed with the use of this drug but cannot yet be theoretically explained must be clearly listed. If it is unclear whether there are any contraindications for this drug, state "not yet determined" in this section of the package insert.
(9) [Important Notes]
Includes precautions when using the drug, situations requiring caution (e.g., liver or kidney impairment, specific TCM syndromes and constitutions), factors affecting efficacy (e.g., food, including tobacco and alcohol), monitoring requirements during therapy (e.g., allergic reactions, regular blood counts, liver and kidney function tests), and effects on clinical laboratory indicators. Specific content can generally be considered from the following aspects:
1. General Precautions: Include any issues that may raise concerns among practicing physicians regarding the drug's safety and efficacy.
2. Allergy Testing. If allergy testing is required prior to administration, describe the testing method, preparation of the test solution, and criteria for interpreting results.
3. Laboratory Tests: Specify which laboratory tests are useful for monitoring treatment efficacy and which help identify potential adverse reactions. Whenever possible, provide reference ranges for normal and abnormal values for specific special tests under certain conditions, along with recommended testing frequencies (before, during, or after treatment).
4. Interference of the Drug with Laboratory Tests If a known drug may interfere with laboratory tests, briefly describe the nature of the interference and refer readers to the section where detailed information is provided.
5 Patient Information: Provide patients with safety and efficacy data regarding medication use, including precautions related to driving and information on potential additive toxic or adverse effects from concomitant drug use.
6. Steps, methods, and precautions to take when adverse reactions occur.
7. Abuse or drug dependency content.
8. Precautions based on traditional Chinese medicine (TCM) theory and clinical experience, including contraindications due to TCM syndromes, disease mechanisms, or body constitution, as well as dietary restrictions and drug interactions.
9 Other precautions to consider when taking this medication.
(X) Medication Use in Pregnant and Breastfeeding Women
This section details the drug's effects on pregnancy (e.g., placental transfer, impact on fetal development, or teratogenicity) and breastfeeding (e.g., excretion in breast milk and effects on the infant). It also specifies whether the drug can be used and provides usage precautions.
If reliable experimental or literature evidence is unavailable to describe this, retain the section title and state "Not known." If relevant animal trials and/or clinical studies have been conducted, draft the content in accordance with the requirements for use of chemical drugs and biologics by pregnant and lactating women as specified in the "Guiding Principles for Instructions for Chemical Drugs and Biological Products."
(11) [Pediatric Use]
Due to differences in drug absorption, metabolism, and response between children and adults, it is essential to specify whether this medication is suitable for pediatric use and to provide relevant precautions. In this context, "children" refers to individuals from birth up to 16 years of age.
1. If adequate and well-controlled clinical studies in pediatric populations support a specific indication for use in children, this indication should be listed under "Indications and Usage," and the pediatric dosage should be specified under "Dosage and Administration." If the drug is intended for both adults and children, separate dosages should be provided under "Dosage and Administration."
2. In the "Pediatric Use" section, specify all restrictions for pediatric indications, the necessity of special monitoring, and any drug-related adverse events observed in children (e.g., neonates under one month old). Include differences in drug response between children and adults, as well as other information regarding the safe and effective use of the drug in the pediatric population. If necessary, provide more detailed discussion in the "Clinical Studies" section.
3. If there is insufficient evidence to support pediatric indications, the following statement should be included in the "Pediatric Use" section: "The safety and effectiveness of the drug have not been established in children within the following age groups."
4. Clinical studies have not been conducted in special pediatric populations (e.g., infants under 1 year of age). It should be stated that the safety and efficacy of this drug in children aged {1} to {2} years are unknown.
If reliable experimental or literature evidence is unavailable, the corresponding section title shall be omitted from the instructions.

(XII) [Use in Elderly]
Due to age-related declines in physiological functions, older adults may metabolize and respond to medications differently than younger adults. This can affect the efficacy and safety of drug use in this population. Therefore, instructions must specify whether this medication is suitable for elderly patients and provide relevant usage precautions.
If not otherwise specified, information in the "Use in Specific Populations" section applies to patients aged 65 and older.
1. If clinical studies conducted in elderly populations with adequate and rigorous controls support a specific indication for the elderly, this must be listed under "Indications" in the package insert, and the corresponding dosage for elderly patients must be specified under "Dosage and Administration."
Provide the information in the label. In the "Use in Elderly" section of the prescribing information, include any restrictions on indications for elderly patients, the need for special monitoring, specific risks associated with using the drug in elderly patients for those indications, and other information relevant to the safe and effective use of the drug in this population.
2. To distinguish indications specifically for geriatric patients, any approved indications for general adult populations that are also applicable to geriatric patients should be included in the "Use in Geriatric Patients" section, along with all available information on appropriate medication use for this population.
If a section cannot be substantiated with reliable experimental or literature evidence, its heading will be omitted from the instructions.
(13) [Drug Interactions]
Special considerations based on TCM principles (e.g., the Eighteen Incompatibles and Nineteen Mutual Restraints).
List drugs that interact with this medication, describe the interaction outcomes, and provide precautions for concurrent use.
For injectable products, studies on drug-drug interactions must be clearly reported. If such studies are not available, it must be explicitly stated that no clinical data exist regarding co-administration with other drugs. Consequently, the safety and efficacy of concomitant use—particularly simultaneous or mixed infusion/injection—have not been established.
(XIV) [Clinical Research]
Overview of clinical studies for this product shall be described accurately and objectively. This section is omitted for drugs that have not undergone clinical studies.
This section should include: study design, inclusion and exclusion criteria, sample size, dosing regimen, concomitant therapies (e.g., with conventional drugs), primary endpoints, efficacy criteria and results, statistical conclusions and clinical implications, safety parameters, number of subjects assessed for safety, and outcomes; details on any anomalies observed with analysis; and adverse events.
This section applies primarily to new drugs approved based on large-scale, rigorously controlled clinical trials.
(15) [Pharmacology and Toxicology]
This section includes pharmacological effects and toxicology studies. Pharmacological effects cover both preclinical and clinical aspects.
Nonclinical pharmacological effects should be nonclinical trial results closely related to established clinical efficacy or helpful in elucidating clinical pharmacology, including in vitro and/or animal study results. These must be clearly identified as nonclinical trials (e.g., rat studies).
Clinical pharmacology describes how the drug affects the human body. For traditional Chinese medicine (TCM), if the mechanism of action is well understood, it should be stated; otherwise, it may be omitted.
The toxicology section includes nonclinical toxicity study results relevant to clinical application that help assess the safety of a drug in humans. It should describe key information such as animal species, dosing regimen (dose, duration, and route of administration), and major toxicological findings.
The toxicology study of compound preparations should, to the extent possible, include results from toxicity studies on the combined administration of the components. If such data are unavailable, relevant toxicology information for individual ingredients may be included instead. The primary focus should be on the specific herbal ingredients with well-established and widely recognized toxicity profiles. Currently, the following ingredients may be considered: those specified in the State Council's "Medical...
Traditional Chinese medicine (TCM) products within the scope of the "Measures for the Administration of Toxic Drugs for Medical Use," including plants containing aristolochic acid and other drugs recently identified with significant adverse reactions. Medicinal ingredients that are prone to obvious adverse effects or toxic side effects when used in excessive, overdosed, or long-term quantities must be highlighted. Prescriptions containing the "Eighteen Incompatibilities" or "Nineteen Mutual Restraints" also require explicit disclosure. Where necessary, such warnings should be included in the Precautions section.
If a reliable experimental or literature basis is unavailable to support the content, the corresponding section title will be omitted from the package insert.
(XVI) [Pharmacokinetics]
This item refers to the entire process of a drug's absorption, distribution, metabolism, and excretion in the body, along with its pharmacokinetic parameters. It includes both preclinical and clinical pharmacokinetics.
If a reliable experimental or literature basis is unavailable to support the content, the corresponding section title will be omitted from the package insert.
(17) [Specifications]
Representations shall conform to pharmacopoeia standards. For products with two or more specifications, each must be listed separately.
(18) [Storage]
Specify conditions according to pharmacopoeia standards and provide detailed annotations.
(19) [Packaging]
Includes packaging specifications and primary packaging materials and containers that directly contact the drug. Packaging specifications refer to the size of the basic packaging unit.
(20) [Expiration Date]
Refers to the period during which a drug maintains its quality under specified storage conditions.
The validity period may be expressed as X years or XX months (X shall be an Arabic numeral) in the instructions. It must be consistent with the validity period specified in the latest drug quality standard for the medicine.

(21) [Approval Number]
Refers to the drug approval number approved by the state, the import drug registration certificate number, or the medical product registration certificate number.
(22) [Manufacturer]
Refers to the manufacturer of the drug. This information must match exactly with the content in the drug approval documents and be listed as follows:
Company Name:
Production Address:
Zip Code:
Phone number: Must include the country code
Fax Number: Must include domestic area code
Website: (Optional; leave blank if not applicable)
(23) [References]
References must be authentic and published in reputable journals.
Citations must include full details (e.g., journal name, volume, issue, and page numbers). Content should support the appropriate use of drugs and must not be misleading.
(24) [Publication Date]
Date of initial approval or revision for this manual.
   V. References
1．Draft "Provisions on the Administration of Drug Instructions and Labels" published by the State Food and Drug Administration (Draft for Comments) (2003, 7, 31)
2. Good Manufacturing Practice (GMP) for Drugs (1998 Revision)
3. "Drug Administration Law" (2001)
4. "Regulations on the Implementation of the Drug Administration Law" 2002
5. "Measures for the Administration of Drug Registration" (2002)
6. "Provisions on the Administration of Drug Packaging, Labels, and Instructions" (State Drug Administration Order No. 23, issued on 15 10, 2000)
7. Analysis and Research on Drug Package Inserts. Sun Zhiyou, Zeng Hongzhuan. Chinese Pharmaceutical Affairs 1996; (4) 266
8. 213 Investigation and Analysis of Instructions for Chinese Patent Medicines Xu Xuejun China Pharmaceutical Affairs 2002; 16(7) 403
9. FDA Requirements for Prescription Drug Labeling (Translation) Zhang Jie, Chinese Journal of Clinical Pharmacology 1999; (5) 394
10. An Overview of the Main Features of Japanese Tsumura Kampo Preparation Package Inserts – Shen Jia, Shen Yan. Chinese Patent Medicine 1999; (1) 49
11. Reflections on the Expression of Indications and Functions in Package Inserts for Chinese Patent Medicines. Zhuang Jie, Zhang Limin. China Journal of Chinese Materia Medica 2001; (7)11
12. Comparative Study on the Drafting Regulations for Chinese Herbal Medicine and Swiss Plant-Based Medicine Package Inserts. Da Hongyuan, Xiao Huilai. New Drug Research & Clinical Trials 2000; (4)16
13. 369 Types of Traditional Chinese Medicine Labels and Instructions: Investigation and Analysis. Zhang Zhiguo et al., China Pharmaceutical Industry 2002; (9) 16
14. FDA. Labeling for Over-the-Counter Human Drug Products, Oct 2002
15. Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (I) 10/26/00
16. Clinical Studies Section of Labeling for Prescription Drugs and Biologics: Content and Format
17. Guideline on the Readability of the Label and Package Leaflet for Human Medicinal Products