医院疾病分类类目表
卫生部
医院疾病分类类目表
卫生部
疾病分类 1973年 国际疾病分类编码 分类编码
1 总计 1 001－999，Ｖ01－Ｖ22
2 传染病和寄生虫病小计 2－30 001－139
3 传染病计 2 ＊
4 其中：霍乱 001
5 伤寒和副伤寒 8 002
6 细菌性食物中毒 003，005
7 痢疾 7 004，006
8 结核病 010－018
9 内：肺结核 20 011
10 结核性脑膜炎 21 013．0
11 肠结核及结核性腹膜炎 22 014
12 骨和关节结核 23 015
13 淋巴腺结核 24 017．2
14 布氏杆菌病 14 023
15 白喉 4 032
16 百日咳 13 033
17 猩红热 9 034．1
18 流行性脑脊髓膜炎 10 036．0
19 破伤风 037
20 败血症 038
21 急性脊髓灰质炎 12 045
22 麻疹 11 055
23 流行性乙型脑炎 3 062．0
24 流行性出血热 065，078，6
25 病毒性肝炎 16 070
26 狂犬病 071
27 斑疹伤寒 5 080，081
28 回归热 6 087
29 性病 19 090－099
30 钩端螺旋体病 18 100
31 寄生虫病计 26 ※
32 其中：疟 疾 27 084
33 血吸虫病 28 120
34 丝虫病 29 125
35 钩虫病 30 126
36 肿瘤小计 42 140－239
37 恶性肿瘤计 43 140－208，230－234
38 其中：鼻咽恶性肿瘤 44 147，230．0
39 食管恶性肿瘤 45 150，230．1
40 胃恶性肿瘤 46 151，230．2
41 小肠、十二指肠恶性肿瘤 47 152，230．7
42 结肠恶性肿瘤 47 153，230．3
43 直肠和肛门恶性肿瘤 47 154，230．4－6
44 肝恶性肿瘤 48 155，230．8
45 胰恶性肿瘤 157，230．9
46 喉恶性肿瘤 161，231．0
47 气管、支气管和肺恶性肿瘤 49 162，231．2
48 骨和关节软骨恶性肿瘤 170
49 女性乳房恶性肿瘤 50－ 174，233．0
50 子宫颈恶性肿瘤 51 180，233．1
51 绒毛膜上皮癌 52 181
52 卵巢恶性肿瘤 183．0，233．3
53 膀胱恶性肿瘤 188，233．7
54 脑恶性肿瘤 191
55 白血病 53 204－208
56 良性肿瘤计 54 210－229
57 其中：子宫良性肿瘤 218，219
58 脑良性肿瘤 55 225．0－225．2
59 动态未定和性质未特指的肿瘤计 235－239
60 内分泌、营养和代谢疾病及免疫疾病小计 56 240－279
61 其中：甲状腺机能亢进 57 242
62 糖尿病 59 250
63 营养缺乏 260－269
64 内：佝偻病 58 268．0，268．1
65 免疫疾病 279
66 血液和造血器官疾病小计 60 280－289
67 其中：贫血 280－285
68 精神病小计 61 290－319
69 其中：老年期和老年前期器质性精神病 290
70 精神分裂症 62 295
71 儿童期精神病 299
72 神经系统和感觉器官疾病小计 63，64 320－389
73 神经系病计 63 320－359
74 其中：脑膜炎 320，322
75 颅内脓肿 324．0
76 帕金森氏病 332
77 癫痫 345
78 急性感染性多发性神经炎 357．0
79 眼及附器疾病计 64 360－379
80 其中：视网膜脱离和缺损 361
81 青光眼 66 365
82 白内障 67 366
83 角膜疾病 65 370，371
84 耳和乳突疾病计 68－ 380－389
85 其中：中耳炎和乳突炎 381－38
86 循环系统疾病小计 69 390－459
87 其中：急性风湿热 390－39
88 内：急性风湿性关节炎 390
89 心脏病计 70 ＊
90 内：慢性风湿性心脏病 71－ 395－398
91 高血压性心脏病 73 402，404
92 急性心肌梗塞 72－ 410
93 其他冠心病 72－ 411－414
94 肺源性心脏病 75 415，416
95 克山病 74 425．4
96 其他心脏病 77 420－429
97 其他高血压病 78 401，403，405
98 脑血管病 79 430－438
99 内：脑出血 430－432
100 下肢静脉曲张 454
101 呼吸系统疾病小计 80 460－519
102 其中：慢性扁桃体和腺样体病 474
103 肺炎 84 480－486
104 慢性支气管炎 81 491
105 肺气肿 83 492
106 哮喘 82＋ 493
107 尘肺 85－ 500－505
108 消化系统疾病小计 86 520－579
109 其中：口腔、唾液腺及颌疾病 520－529
110 消化性溃疡 88 530．2，53
111 阑尾炎 89 540－543
112 腹腔疝 90 550－553
113 肠梗阻 91 560
114 慢性肝病和肝硬变 92＋ 571
115 胆结石症和胆囊炎 93 574－575
116 泌尿生殖系统疾病小计 94－ 580－629
117 泌尿系统疾病计 94 580－599
118 其中：肾炎和肾变病 95＋ 580－589
119 肾盂炎 96 590
120 泌尿系统结石 97 592，594
121 男性生殖器官疾病计 98 600－608
122 其中：前列腺增生 600
123 乳房疾病计 610－611
124 女性生殖器官疾病计 99 614－629
125 其中：输卵管炎和卵巢炎 614．0－614．2
126 子宫阴道脱垂 618
127 妊娠、分娩和产褥期并发症小计 100 630－676
128 其中：自然流产 634
129 人工流产 635
130 妊娠和分娩出血 640，641，665
131 妊娠高血压综合症 642．4－643
132 妊娠期泌尿生殖道感染 646．6
133 正常分娩 650
134 梗阻性分娩 660
135 产褥期并发症 670－676
136 皮肤和皮下组织疾病小计 101 680－709
137 其中：痈和疖 102 680
138 皮炎 103 ＊
139 肌肉、骨骼系统和结缔组织疾病小计 104＋ 710－739
140 其中：类风湿性关节炎 105 714
141 大骨节病 107 716．0
142 椎间盘疾病 722
143 骨髓炎 106 730．0－730．2
144 先天异常小计 108＋ 740－759
145 其中：先天性心脏病 76 745－74
146 起源于围产期的情况小计 109＋ 760－77
147 其中：早产儿和未成熟儿 111 764－76－
148 产伤 767
149 胎儿及新生儿窒息 768－770
150 新生儿破伤风 110 771．3
151 胎儿及新生儿溶血症 773
152 新生儿硬肿症 778．1
153 体征、症状和不明确情况小计 112 780－799
154 损伤和中毒小计 31－41 800－999
155 其中：骨折 800－829
156 脱位、扭伤和劳损 830－848
157 颅内和体内损伤（包括神经） 850－869，950－951
158 开放性创伤和血管损伤 870－904
159 经口腔进入的异物 930－939
160 烧伤 940－949
161 中毒和毒性效应 960－989
162 与医疗有关的并发症 996－999
163 其他小计 Ｖ01－Ｖ82
164 其中：妊娠监护 Ｖ22－Ｖ23
165 绝育 Ｖ25．2
166 为特殊治疗住院 Ｖ50－Ｖ59
167 个人和人群的检查 Ｖ70－Ｖ82
Ｅ1 损伤和中毒外部原因小计 Ｅ800－Ｅ997
Ｅ2 其中：机动车辆交通事故 Ｅ810－Ｅ819
Ｅ3 机动车以外的运输事故 Ｅ800－Ｅ807，Ｅ826－Ｅ84
Ｅ4 意外中毒 Ｅ850－Ｅ869
Ｅ5 医疗事故，异常反应和晚期并发症 Ｅ870－Ｅ879
Ｅ6 意外跌伤 Ｅ880－Ｅ888
Ｅ7 火灾 Ｅ890－Ｅ899
Ｅ8 由自然和环境因素所致意外事故 Ｅ900－Ｅ909
Ｅ9 意外淹没和沉没 Ｅ910
Ｅ10 意外的机械性窒息 Ｅ913
Ｅ11 坠落物体的意外撞击 Ｅ916
Ｅ12 由机器切割和穿刺工具所致意外事故 Ｅ919，Ｅ920
Ｅ13 触电 Ｅ925
Ｅ14 药物药剂治疗中引起的有害效应 Ｅ930－Ｅ949
Ｅ15 自杀和自伤 Ｅ950－Ｅ959
Ｅ16 他杀和他伤 Ｅ960－Ｅ969
注：1）国际疾病分类编号系指ＩＣＤ－9版的类目编码
2）根据卫生部文件（86）卫计字第184号的要求，医院疾病分类，各省，自治区，直辖市卫生厅（局）可选择
少部分有条件的医院在1987年先试点，待取得经验后再推广。
1986年10月14日
Provisions for Drug Insert Sheets and Labels
Commissioner of SFDA
Provisions for Drug Insert Sheets and Labels
(SFDA Decree No.24)
The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.
Shao Mingli
Commissioner of SFDA
March 15, 2006
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 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.
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 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.
Chapter IV Use of Drug Name and Registered Trademark
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 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, 2005 shall be annulled therefrom.
