標題: 常 用 藥 品 監 管 英 語 與 縮 略 語 [打印本頁] 作者: zhaoyuyong 時間: 2007-4-27 17:13 標題: 常 用 藥 品 監 管 英 語 與 縮 略 語 常 用 藥 品 監 管 英 語 與 縮 略 語
一、監管英語
1.《中華人民共和國藥品管理法》
Drug Control Law of the People's Republic of China
2.藥品生產企業管理
control over drug manufacturers
3.藥品經營企業管理
control over drug distributors
4.醫療機構的藥劑管理
control over medicines in medical institutions
5.藥品管理
control over drugs
6.藥品包裝的管理
control over drug packaging
7.藥品價格和廣告的管理
control over drug price and advertisement
8.藥品監督
inspection of drugs
9.法律責任
legal liabilities
10.藥品標識
labels or marks of the drugs
11.假藥
counterfeit drugs
12.劣藥
inferior drugs
13.藥品檢驗機構
drug quality control laboratory
14.藥品的生產企業
drug manufacturers
15.經營企業
drug distributors
16.醫療機構
medical institutions
17.藥品監督管理部門
drug regulatory agency
18.藥品批準證明文件
drug approval documents
19.行政處分
administrative sanctions
20.刑事責任
criminal liabilities
21.藥品生產質量管理規范
Good Manufacturing Practice for Pharmaceutical Products (GMP)
22.藥品經營質量管理規范
Good Supply Practice for Pharmaceutical Products (GSP)
23.藥品生產許可證
Drug Manufacturing Certificate
24.藥品經營許可證
Drug Supply Certificate
25.醫療機構制劑許可證
Pharmaceutical Preparation Certificate for Medical Institution
26.進口藥品注冊證書
Import Drug License
27.臨床試驗
clinical trial
28.新藥證書
New Drug Certificate
29.藥品批準文號
Drug Approval Number
30.在中華人民共和國境內從事藥品的研制、生產、經營、使用和監督管理的單位或者個人，必須遵守《中華人民共和國藥品管理法》
All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the People's Republic of China shall abide by drug control law of the people's republic of China.
31.國務院藥品監督管理部門主管全國藥品監督管理工作。
The drug regulatory agency of the State Council shall be responsible for drug administration and supervision nationwide.
32.省、自治區、直轄市人民政府藥品監督管理部門負責本行政區域內的藥品監督管理工作。
The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for drug regulation in their administrative areas.
33.藥品監督管理部門設置或者確定的藥品檢驗機構，承擔依法實施藥品審批和藥品質量監督檢查所需的藥品檢驗工作。
The drug quality control laboratories established or designated by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting drug review and approval and controlling drug quality pursuant to the law.
34.開辦藥品生產企業，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準并發給《藥品生產許可證》，憑《藥品生產許可證》到工商行政管理部門辦理登記注冊。
Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency for industry and commerce.
35.《藥品生產許可證》應當標明有效期和生產范圍，到期重新審查發證。
The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reviewing and approval again is required.
36.藥品監督管理部門批準開辦藥品生產企業，應當符合國家制定的藥品行業發展規劃和產業政策，防止重復建設。
When giving approval to the newly-established manufacturer, the drug regulatory agency shall see to it that the development programs and policies set by the State for the pharmaceutical industry shall be complied with so as to prevent duplicate construction.
37.開辦藥品生產企業，必須具備以下條件：（一）具有依法經過資格認定的藥學技術人員、工程技術人員及相應的技術工人；（二）具有與其藥品生產相適應的廠房、設施和衛生環境；（三）具有能對所生產藥品進行質量管理和質量檢驗的機構、人員以及必要的儀器設備；（四）具有保證藥品質量的規章制度。
Any drug manufacturer to be established shall meet the following requirements: (1) stuffed with legally qualified pharmaceutical and engineering professionals and the necessary technical workers;(2) provided with the premises, facilities, and clear environment required for drug manufacturing; (3) having quality management and control units and personnel capable of quality management of and testing for drugs to be produced and the necessary instruments and equipment; and (4) establishing rules and regulations to govern the quality of drugs.
38.藥品生產企業必須按照國務院藥品監督管理部門依據本法制定的《藥品生產質量管理規范》組織生產。藥品監督管理部門按照規定對藥品生產企業是否符合《藥品生產質量管理規范》的要求進行認證；對認證合格的，發給認證證書。
Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency shall inspect a drug manufacturer as to its compliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection.
39.除中藥飲片的炮制外，藥品必須按照國家藥品標準和國務院藥品監督管理部門批準的生產工藝進行生產，生產記錄必須完整準確。
With the exception of the processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity with the National Drug Standard and with the production processes approved by the drug regulatory agency of the State Council, and the production records shall be complete and accurate.
40.藥品生產企業改變影響藥品質量的生產工藝的，必須報原批準部門審核批準。
When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval.
41.生產藥品所需的原料、輔料，必須符合藥用要求。
Active pharmaceutical ingredients (API) and recipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal use.
42.藥品生產企業必須對其生產的藥品進行質量檢驗。
Drug manufacturers shall perform quality test of their products.
43.不符合國家藥品標準或者不按照省、自治區、直轄市人民政府藥品監督管理部門制定的中藥飲片炮制規范炮制的，不得出廠。
No products that do not meet the National Drug Standards or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government may be released.
44.經國務院藥品監督管理部門或者國務院藥品監督管理部門授權的省、自治區、直轄市人民政府藥品監督管理部門批準，藥品生產企業可以接受委托生產藥品。
A drug manufacturer may not accept any contract production of drugs unless it is approved by the drug regulatory agency of the State Council, or by the drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government authorized by the drug regulatory agency of the State Council.
45.開辦藥品批發企業，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準并發給《藥品經營許可證》.
Any newly established drug wholesaler shall be subject to approval of the local drug agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Supply Certificate.
46.開辦藥品零售企業，須經企業所在地縣級以上地方藥品監督管理部門批準并發給《藥品經營許可證》。
Any newly established drug retailer shall be subject to approval and be granted the above certificate by the local drug regulatory agency at or above the county level.
47. 藥品批發、零售企業憑《藥品經營許可證》到工商行政管理部門辦理登記注冊。
With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and commerce.
47.無《藥品經營許可證》的，不得經營藥品。
No one is permitted to distribute drugs without the certificate.
48.《藥品經營許可證》應當標明有效期和經營范圍，到期重新審查發證。
The valid period and the scope of business shall be indicated in the Drug Supply Certificate. For renewal of the certificate upon expiration, reviewing and approval again is required.
49.開辦藥品經營企業必須具備以下條件： （一）具有依法經過資格認定的藥學技術人員；（二）具有與所經營藥品相適應的營業場所、設備、倉儲設施、衛生環境；（三）具有與所經營藥品相適應的質量管理機構或者人員；（四）具有保證所經營藥品質量的規章制度。
A drug distributor to be established shall meet the following requirements:(1) staffed with legally qualified pharmaceutical professionals;(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution;(3) having the quality control units or personnel adaptable the drugs to be distributed; and(4) establishing rules and regulations to govern the quality of the drugs to be distributed.
50.藥品經營企業必須按照國務院藥品監督管理部門依據本法制定的《藥品經營質量管理規范》經營藥品。
Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) set by the drug regulatory agency of the State Council based on this Law.
51.藥品監督管理部門按照規定對藥品經營企業是否符合《藥品經營質量管理規范》的要求進行認證；對認證合格的，發給認證證書。
The drug regulatory agency inspect a drug distributor as to its compliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.
52.藥品經營企業購進藥品，必須建立并執行進貨檢查驗收制度，驗明藥品合格證明和其他標識；不符合規定要求的，不得購進。
After receiving the drug purchased, drug distributors shall pass the established examination and acceptance system, and check the certificate of drug quality, labels and others marks; no drugs that fail to meet the requirements are permitted to be purchased.
53.藥品經營企業購銷藥品，必須有真實完整的購銷記錄。
Drug distributors shall keep a real and perfect records of purchasing and selling drugs.
54.購銷記錄必須注明藥品的通用名稱、劑型、規格、批號、有效期、生產廠商、購（銷）貨單位、購（銷）貨數量、購銷價格、購（銷）貨日期及國務院藥品監督管理部門規定的其他內容。
In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specified by the drug regulatory agency of the State Council.
55.藥品經營企業銷售中藥材，必須標明產地。
Drug distributors shall indicate the habitat of Chinese crude drugs to be sold.
56.藥品經營企業必須制定和執行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質量。
A drug distributor shall pass the established system for drug storage, and take necessary measures to ensure drug quality, such as cold storing, protecting from being frozen and moisture and guarding against insects and rodents.
57.藥品入庫和出庫必須執行檢查制度。
An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse.
58.城鄉集市貿易市場可以出售中藥材，國務院另有規定的除外。
Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council.
59.城鄉集市貿易市場不得出售中藥材以外的藥品，但持有《藥品經營許可證》的藥品零售企業在規定的范圍內可以在城鄉集市貿易市場設點出售中藥材以外的藥品。
No drugs other than the Chinese crude drugs may be sold at fairs in urban and rural areas, but drug retailers holding the Drug Supply Certificate may, within the specified business scope, sell such drugs at the stores they set up at the fairs.
60.醫療機構配制制劑，須經所在地省、自治區、直轄市人民政府衛生行政部門審核同意，由省、自治區、直轄市人民政府藥品監督管理部門批準，發給《醫療機構制劑許可證》。
Dispensing pharmaceutical preparations by a medical institution shall be subject to reviewing and permission by the health administration agency of the government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory agency of the government. A Pharmaceutical Preparation Certificate for Medical Institution shall be issued by the above drug regulatory agency.
61.無《醫療機構制劑許可證》的醫療機構，不得配制制劑。
No medical institution is permitted to dispense pharmaceutical preparations without the Pharmaceutical Preparation Certificate for Medical Institution.
62.《醫療機構制劑許可證》應當標明有效期，到期重新審查發證。
The term of validation shall be noted in the Pharmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required.
63.醫療機構配制的制劑，應當是本單位臨床需要而市場上沒有供應的品種，并須經所在地省、自治區、直轄市人民政府藥品監督管理部門批準后方可配制。
The pharmaceutical preparations to be dispensed by the medical institution shall be those satisfying the clinic need of the institution but not available on the market. It shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government.
64.醫療機構配制的制劑，不得在市場銷售。
No pharmaceutical preparations dispensed by medical institutions are permitted to be marketed.
65.研制新藥，必須按照國務院藥品監督管理部門的規定如實報送研制方法、質量指標、藥理及毒理試驗結果等有關資料和樣品，經國務院藥品監督管理部門批準后，方可進行臨床試驗。
A full description of a new drug research and development including the manufacturing process, quality specifications, results of pharmacological and toxicological study, and the related data as well as the samples shall, in accordance with the regulations of the drug regulatory agency of the State Council, be truthfully submitted to the above agency for reviewing and approval.
66.完成臨床試驗并通過審批的新藥，由國務院藥品監督管理部門批準，發給新藥證書。
When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council.
67.藥物的非臨床安全性評價研究機構和臨床試驗機構必須分別執行藥物非臨床研究質量管理規范、藥物臨床試驗質量管理規范。
The institutions for non-clinical safety evaluation and study and for clinical study institutions shall respectively follow the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).
68.生產新藥或者已有國家標準的藥品的，須經國務院藥品監督管理部門批準，并發給藥品批準文號；但是，生產沒有實施批準文號管理的中藥材和中藥飲片除外。
Production of a new drug or production of a drug complying with National Drug Standards shall be subject to the approval by the drug regulatory agency of the State Council, and a drug approval number shall be issued for it, with the exception of the Chinese crude drugs and the prepared slices of Chinese crude drugs in which no control by approval number is exercised.
69.實施批準文號管理的中藥材、中藥飲片品種目錄由國務院藥品監督管理部門會同國務院中醫藥管理部門制定。
The list of the Chinese crude drugs and the prepared slices of the Chinese crude drugs to be controlled by the approval number shall be compiled by the drug regulatory agency of the State Council, jointly with the administrative agency for traditional Chinese medicines of the State Council.
70.藥品生產企業在取得藥品批準文號后，方可生產該藥品。
A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.
71. 藥品必須符合國家藥品標準。
Drugs shall comply with the National Drug Standards.
72.國務院藥品監督管理部門頒布的《中華人民共和國藥典》和藥品標準為國家藥品標準。
The Pharmacopoeia of the People's Republic of China and the Drug Standards issued by the drug regulatory agency of the State Council shall serve as the National Drug Standards.
73.國務院藥品監督管理部門組織藥典委員會，負責國家藥品標準的制定和修訂。
The drug regulatory agency of the State Council shall organize a pharmacopoeia commission, which shall be responsible for formulating and revising the National Drug Standards.
74.國務院藥品監督管理部門的藥品檢驗機構負責標定國家藥品標準品、對照品。
The drug control institution affiliated to the drug regulatory agency of the State Council is responsible for standardizing the National Drug Standard Substance and Reference Substance.
75.藥品生產企業、藥品經營企業、醫療機構必須從具有藥品生產、經營資格的企業購進藥品；但是，購進沒有實施批準文號管理的中藥材除外。
Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which are qualified for production and distribution, with the exception of the Chinese crude drugs in which no control by approval number is exercised.
76.國家對麻醉藥品、精神藥品、醫療用毒性藥品、放射性藥品，實行特殊管理。
The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals.
77.國家實行中藥品種保護制度。
The State adopts a protection system for certain traditional Chinese medicines.
78.國家對藥品實行處方藥與非處方藥分類管理制度。
The State adopts a system of classified management for prescription and non-prescription drugs.
79.藥品進口，須經國務院藥品監督管理部門組織審查，經審查確認符合質量標準、安全有效的，方可批準進口，并發給進口藥品注冊證書。
Reviewing the drugs to be imported shall come of the jurisdiction of the drug regulatory agency of the State Council. A drug is permitted to be imported only upon approval granted after confirming that it conforms to the quality, safely and efficiency through examination, and a drug importation license shall be issued.
80.國家實行藥品儲備制度。
The State adopts a policy for drug storage for future use.
81.國內發生重大災情、疫情及其他突發事件時，國務院規定的部門可以緊急調用企業藥品。
When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from the enterprises to meet the urgent need.
82. 禁止生產（包括配制）、銷售假藥。
Production (including dispensing) and distribution of counterfeit drugs are prohibited.
83.有下列情形之一的，為假藥：
A drug falling into the following categories is deemed as a counterfeit drug:
（一）藥品所含成份與國家藥品標準規定的成份不符的；
The ingredients in the drug are different from those specified by the National Drug Standards;
（二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。
It is not the same drug which is claimed by its name or in reality it is not a drug at all.
84.有下列情形之一的藥品，按假藥論處：
A drug falling into the following categories shall be deemed as a counterfeit drug:
（一）國務院藥品監督管理部門規定禁止使用的；
It’s use is prohibited by the provisions of the drug regulatory agency of the State Council;
（二）依照本法必須批準而未經批準生產、進口，或者依照本法必須檢驗而未經檢驗即銷售的；
It is produced or imported without approval, or marketed without being tested, as required by the Law;
（三）變質的；
It is deteriorated;
（四）被污染的；
It is contaminated;
（五）使用依照本法必須取得批準文號而未取得批準文號的原料藥生產的；
It is produced by using active pharmaceutical ingredients without approval number as required by this Law;
（六）所標明的適應癥或者功能主治超出規定范圍的。
The indications or functions indicated are beyond the specified scope.
85. 禁止生產、銷售劣藥。
Production and distribution of drugs of inferior quality are prohibited.
86.藥品成份的含量不符合國家藥品標準的，為劣藥。
A drug with content not up to the National Drug Standards is a drug of inferior quality.
87.有下列情形之一的藥品，按劣藥論處：
A drug falling into the following categories shall be deemed as a drug of inferior quality:
（一）未標明有效期或者更改有效期的；
The date of expiry is not indicated or is altered;
（二）不注明或者更改生產批號的；
The batch number is not indicated or is altered;
（三）超過有效期的；
It is beyond the date of expiry;
（四）直接接觸藥品的包裝材料和容器未經批準的；
No approval certificate is obtained for the immediate packaging material or container;
（五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的；
Colorants, preservatives, spices, flavorings, or other recipients have been added without authorization; or
（六）其他不符合藥品標準規定的。
Other cases where the drug standards are not complied with.
88.列入國家藥品標準的藥品名稱為藥品通用名稱。已經作為藥品通用名稱的，該名稱不得作為藥品商標使用。
A drug name listed in the National Drug Standards is an adopted name in China. Such an adopted name is not permitted to be used as a trademark.
89.藥品生產企業、藥品經營企業和醫療機構直接接觸藥品的工作人員，必須每年進行健康檢查。
Staff members of drug manufacturers, drug distributors and medical institutions who make a direct contact with drugs shall receive physical examination annually.
90.患有傳染病或者其他可能污染藥品的疾病的，不得從事直接接觸藥品的工作。
Those who suffer from infectious diseases or any other diseases that may cause drug contamination are not permitted to undertake any job in direct contact with drugs.
91. 直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標準，并由藥品監督管理部門在審批藥品時一并審批。
Immediate packaging materials and containers shall meet the requirements for medicinal use and comply with the standards for ensuring human health and safety. They along with the drugs shall be subject to reviewing and approval by the drug regulatory agency.
92. 藥品包裝必須按照規定印有或者貼有標簽并附有說明書。
A label shall be printed or stuck on the drug package with an insert sheet attached as required by regulations.
93.標簽或者說明書上必須注明藥品的通用名稱、成份、規格、生產企業、批準文號、產品批號、生產日期、有效期、適應癥或者功能主治、用法、用量、禁忌、不良反應和注意事項。
In the label or insert sheet shall be indicated the adopted name of the drug, its ingredients, strength, manufacturer, approval number, product batch number, production date, date of expiry, indications or functions, usage, dosage, contraindications, drug adverse reactions, and precautions.
94.麻醉藥品、精神藥品、醫療用毒性藥品、放射性藥品、外用藥品和非處方藥的標簽，必須印有規定的標志。
Specified marks shall be printed in the label of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive pharmaceuticals, drugs for topical use, and non-prescription drugs.
95.藥品的生產企業、經營企業和醫療機構必須執行政府定價、政府指導價，不得以任何形式擅自提高價格。
Drug manufacturers, drug distributors and medical institutions shall comply with the prices fixed or guided by the government. No one is permitted to raise prices in any manner without authorization.
96.禁止藥品的生產企業、經營企業和醫療機構在藥品購銷中帳外暗中給予、收受回扣或者其他利益。
Drug manufacturers, drug distributors and medical institutions are prohibited from secret offering or accepting rake-offs or other benefits (not shown in the account book) in the course of purchasing and selling drugs.
97.禁止藥品的生產企業、經營企業或者其代理人以任何名義給予使用其藥品的醫療機構的負責人、藥品采購人員、醫師等有關人員以財物或者其他利益。
Drug manufacturers, drug distributors or their agents are prohibited from offering, under any pretence, money or goods of value or other benefits to leading people, drug purchasers, physicians, or other related persons of the medical institutions where their drugs are purchased.
98.藥品廣告須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準，并發給藥品廣告批準文號；未取得藥品廣告批準文號的，不得發布。
Drug advertisement shall be subject to approval by the drug regulatory agencies of the government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located and an approval number of drug advertisement shall he issued. No one is permitted to release advertisement without the approval number.
99.處方藥可以在國務院衛生行政部門和國務院藥品監督管理部門共同指定的醫學、藥學專業刊物上介紹，但不得在大眾傳播媒介發布廣告或者以其他方式進行以公眾為對象的廣告宣傳。
Prescription drugs may be introduced in the medical or pharmaceutical professional journals jointly designated by the administrative agency of health and the drug regulatory agency of the State Council, but their advertisements are not permitted to be released by mass media or disseminated to the general public by other means.
100.藥品廣告的內容必須真實、合法，以國務院藥品監督管理部門批準的說明書為準，不得含有虛假的內容。
The content of drug advertisement shall be truthful and lawful, and shall be based on the insert sheet approved by the drug regulatory agency of the State Council. The false content shall not be contained in advertisement.
101.藥品廣告不得含有不科學的表示功效的斷言或者保證；不得利用國家機關、醫藥科研單位、學術機構或者專家、學者、醫師、患者的名義和形象作證明。
No unscientific conclusion or guarantee on drug efficacy is permitted to be included in drug advertisement; names or images of government agencies, medical or pharmaceutical research institutions, academic institutions, or experts, scholars, physicians and patients are prohibited from being used as evidence for drug advertising.
102.非藥品廣告不得有涉及藥品的宣傳。
Non-drug advertisements not permitted to involve with drug promotion.
103.藥品監督管理部門進行監督檢查時，必須出示證明文件，對監督檢查中知悉的被檢查人的技術秘密和業務秘密應當保密。
When people from drug regulatory agencies conduct supervision and inspection, they shall show their identification documents, and shall keep confidential the technical and business secrets of the persons or the institutions under inspection that have been informed in the course of supervision and inspection.
104.藥品監督管理部門根據監督檢查的需要，可以對藥品質量進行抽查檢驗。
Drug regulatory agencies may conduct selective testing of drug quality in light of the need of supervision and inspection.
105.抽查檢驗應當按照規定抽樣，并不得收取任何費用。
Sampling for selective testing shall be carried out according to relevant regulations, and no fees are permitted to be charged for sampling or testing.
106.藥品監督管理部門對有證據證明可能危害人體健康的藥品及其有關材料可以采取查封、扣押的行政強制措施。
The drug regulatory agency shall take administrative enforcement to seal or seize the drugs and related materials proved to be potentially harmful to human health and shall.
107.藥品監督管理部門應當按照規定，依據《藥品生產質量管理規范》、《藥品經營質量管理規范》，對經其認證合格的藥品生產企業、藥品經營企業進行認證后的跟蹤檢查。
Drug regulatory agencies shall, in accordance with regulations and on the basis of the GMP and GSP, make the follow-up inspection on the certified drug manufacturers and distributors.
108.地方人民政府和藥品監督管理部門不得以要求實施藥品檢驗、審批等手段限制或者排斥非本地區藥品生產企業依照本法規定生產的藥品進入本地區。
With regard to the drugs produced according to the provisions of this Law by drug manufacturers not located in the region, the local government and drug regulatory agency are not permitted to restrict or refuse their access to the region.
109.國家實行藥品不良反應報告制度。
The State has established and exercised the reporting system on adverse drug reaction (ADR).
110.未取得《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》生產藥品、經營藥品的，依法予以取締
Without Drug Manufacturing Certificate, Drug Supply Certificate or Pharmaceutical Preparation Certificate for Medical Institution, the manufacturer or distributor of drug or medical institution shall be banned to produce or distribute drugs.
111.(1)生產、銷售假藥的，沒收違法生產、銷售的藥品和違法所得，并處違法生產、銷售藥品貨值金額二倍以上五倍以下的罰款；
Where counterfeit drugs are produced or sold, the drugs illegally produced or sold and the illegal income shall be confiscated, and a fine not less than two times but not more than five times the value of the said drugs shall be collected.
(2)有藥品批準證明文件的予以撤銷，并責令停產、停業整頓；
The approval documents, if any, shall be withdrawn and an order shall be given to suspend production or business operation for rectification.
(3)情節嚴重的，吊銷《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》；構成犯罪的，依法追究刑事責任。
If the circumstances are serious, the Drug Manufacturing Certificate, Drug Supply Certificate or Pharmaceutical Preparation Certificate for Medical Institution shall be revoked. If a crime is constituted, criminal liabilities shall be investigated under the law.
112.(1)生產、銷售劣藥的，沒收違法生產、銷售的藥品和違法所得，并處違法生產、銷售藥品貨值金額一倍以上三倍以下的罰款；
Where inferior drugs are produced or sold, the drugs illegally produced or sold and the illegal income shall be confiscated, and a fine not less than but not more than three times the value of the said drugs shall also be collected.
(2)情節嚴重的，責令停產、停業整頓或者撤銷藥品批準證明文件、吊銷《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》；
If the circumstances are serious, an order shall be given to suspend production or business operation for rectification, or the drug approval documents shall be withdrawn and the Drug Manufacturing Certificate, the Drug Supply Certificate, or the Pharmaceutical Preparation Certificate for Medical Institution shall be revoked.
(3)構成犯罪的，依法追究刑事責任。
If a crime is constituted, criminal liabilities shall be investigated under the law.
113.藥品，是指用于預防、治療、診斷人的疾病，有目的地調節人的生理機能并規定有適應癥或者功能主治、用法和用量的物質，包括中藥材、中藥飲片、中成藥、化學原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清、疫苗、血液制品和診斷藥品等。
Drugs refer to the products that are used in the prevention, treatment and diagnosis of human diseases and intended for the regulation of the physiological functions of human beings, with specifications of indications, usage and dosage. They include Chinese crude drugs, prepared slices of Chinese crude drugs, traditional Chinese medicines, chemical drug substances (API) and their preparations, antibiotics, biochemical drugs, radioactive pharmaceuticals, serum, vaccines, blood products, and diagnostic agents.
114.輔料，是指生產藥品和調配處方時所用的賦形劑和附加劑。
Excipients refer to the vehicles and additives intended for manufacturing drug dosage forms and prescription dispensing.
115.藥品生產企業，是指生產藥品的專營企業或者兼營企業。
Drug manufacturers refer to enterprises exclusively or partly engaged in drug production.
116.藥品經營企業，是指經營藥品的專營企業或者兼營企業。
Drug distributors refer to enterprises exclusively or partly engaged in drug distribution.
117.國務院藥品監督管理部門負責全國的醫療器械監督管理工作。
The drug regulatory agency of the State Council is responsible for supervision and administration of medical devices nationwide.
118.國家對醫療器械實行分類管理。
The State shall carry out the policy of classification administration of medical devices.
119.國家對醫療器械實行產品生產注冊制度。
The State shall implement a product registration system for manufacturing medical devices.
120.生產第一類醫療器械，由設區的市級人民政府藥品監督管理部門審查批準，并發給產品生產注冊證書。
Class I medical devices shall be inspected, approved and issued a registration certificate by the drug regulatory agency of the government of the municipalities with districts.
121.生產第二類醫療器械，由省、自治區、直轄市人民政府藥品監督管理部門審查批準，并發給產品生產注冊證書。
Class Ⅱ medical devices shall be inspected, approved and issued registration certificates by the drug regulatory agency of provinces, autonomous regions and municipalities directly of the Central Government.
122.生產第三類醫療器械，由國務院藥品監督管理部門審查批準，并發給產品生產注冊證書。生產第二類、第三類醫療器械，應當通過臨床驗證。
Class Ⅲ medical devices shall be inspected, approved and issued registration certificates by the drug regulatory agency directly under the State Council.
123.醫療器械產品注冊證書有效期四年。
The term of validity for the registration certificate of medical devices is four years.
124.生產醫療器械，應當符合醫療器械國家標準；沒有國家標準的，應當符合醫療器械行業標準。
Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.
125.醫療器械的使用說明書、標簽、包裝應當符合國家有關標準或者規定。
The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.
126.醫療器械及其外包裝上應當按照國務院藥品監督管理部門的規定，標明產品注冊證書編號。
The registration number of a medical device shall be marked on the product itself and on the external package according to the provisions of the drug regulatory agency of the State Council.
127.開辦第一類醫療器械生產企業，應當向省、自治區、直轄市人民政府藥品監督管理部門備案。
For the manufacturing of class I medical devices, it requires that the enterprise file a record with the drug regulatory agency of provinces, autonomous regions or municipalities directly under the Central Government.
128.開辦第二類、第三類醫療器械生產企業， 應當經省、自治區、直轄市人民政府藥品監督管理部門審查批準，并發給《醫療器械生產企業許可證》。
For the manufacturing of class Ⅱ and/or class Ⅲ medical devices, it requires inspection and approval by the drug regulatory agency of the provinces, autonomous regions and municipalities directly under the Central Government, who will then issue a Medical Device Manufacturing Enterprise License.
129.《醫療器械生產企業許可證》有效期5年，有效期屆滿應當重新審查發證。
The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration, re-inspection and license renewal shall be conducted.
130.醫療機構不得使用未經注冊、無合格證明、過期、失效或者淘汰的醫療器械。
Medical institutions shall not use medical devices without registration, or without certificate for qualified products, or they shall not use medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.
131.醫療器械經營企業不得經營未經注冊、無合格證明、過期、失效或者淘汰的醫療器械。
Distribution enterprises shall not distribute medical devices without registration certificates or certificates for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.
132.醫療器械經營企業和醫療機構應當從取得《醫療器械生產企業許可證》的生產企業或者取得《醫療器械經營企業許可證》的經營企業購進合格的醫療器械，并驗明產品合格證明。
Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License. Their certificate of qualified products shall be verified.
133.醫療機構對一次性使用的醫療器械不得重復使用；使用過的，應當按照國家有關規定銷毀，并作記錄。
Medical institutions shall not re-use medical devices labeled for single use, and shall destroy them after use with record, according to relevant provisions of the state.
134.國家建立醫療器械質量事故報告制度和醫療器械質量事故公告制度。
The State shall establish a reporting system for quality accident and a notifying system of medical devices.
135.經國務院藥品監督管理部門會同國務院質量技術監督部門認可的檢測機構，方可對醫療器械實施檢測。
Only testing institutions accredited by the drug regulatory agency in conjunction with the quality and technical supervision agency of the State Council may conduct medical device test.
136.醫療器械檢測機構及其人員對被檢測單位的技術資料負有保密義務，并不得從事或者參與同檢測有關的醫療器械的研制、生產、經營和技術咨詢等活動。
Medical device testing institutions and their staff members shall keep strictly confidential all technical information provided by enterprises whose products are being tested, and shall not conduct or be involved in research and development, manufacturing, distribution, and technical consultation related to the devices tested.
137.對已經造成醫療器械質量事故或者可能造成醫療器械質量事故的產品及有關資料，縣級以上地方人民政府藥品監督管理部門可以予以查封、扣押。
For products having caused or which may potentially cause quality incidents, the drug regulatory agency of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.
138.醫療器械廣告應當經省級以上人民政府藥品監督管理部門審查批準；未經批準的，不得刊登、播放、散發和張貼。
Advertisements of medical devices shall be reviewed and approved by the drug regulatory agency of governments at provincial level and above, and shall not be published, broadcast, circulated or posted before the approval.
139.醫療器械廣告的內容應當以國務院藥品監督管理部門或者省、自治區、直轄市人民政府藥品監督管理部門批準的使用說明書為準。
The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory agency of the State Council or the drug regulatory agency of the governments of provinces, autonomous regions and municipalities directly under the Central Government.
140.醫療器械監督管理人員濫用職權、徇私舞弊、玩忽職守，構成犯罪的，依法追究刑事責任；尚不構成犯罪的，依法給予行政處分。
In cases where personnel engaged in the supervision and administration of medical devices abuse their power, and pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of the Regulation, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled pursuant to the law. For those not committing crimes, disciplinary punishment shall be given pursuant to the relevant regulations.
141.第一類醫療器械是指，通過常規管理足以保證其安全性、有效性的醫療器械。
Class I Medical Devices are those for which safety and effectiveness can be ensured through a routine administration.
142.第二類醫療器械是指，對其安全性、有效性應當加以控制的醫療器械。
Class Ⅱ Medical Devices are those for which further control is required to ensure their safety and effectiveness.
143.第三類醫療器械是指，植入人體；用于支持、維持生命；對人體具有潛在危險，對其安全性、有效性必須嚴格控制的醫療器械。
Class Ⅲ Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or with some potential risk to the human body and thus shall be strictly controlled in respect to safety and effectiveness.
144.醫療器械，是指單獨或者組合使用于人體的儀器、設備、器具 、材料或者其他物 品，包括所需要的軟件；其用于人體體表及體內的作用不是用藥理學、免疫學或者代謝的手段獲得，但是可能有這些手段參與并起一定的輔助作用；其使用旨在達到下列預期目的：
“Medical devices” refer to : any instrument, equipment apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but may be assisted in its function by such means; the use of medical devices is to achieve the following intended objectives:
（一）對疾病的預防、診斷、治療、監護、緩解；
（1）prevention, diagnosis, treatment, monitoring or alleviation of disease;
（二）對損傷或者殘疾的診斷、治療、監護、緩解、補償；
（2）diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
（三）對解剖或者生理過程的研究、替代、調節；
（3）investigation, replacement or regulation for anatomical or a physiological process;
（四）妊娠控制。
（4）control of conception.
145.醫療器械監督管理條例
The Regulation for the Supervision and Administration of Medical Devices.
146.注冊證書
Registration certificates.
147.醫療器械生產企業許可證
Medical Device Manufacturing Enterprise License.
148.醫療器械經營企業許可證
Medical Device Distributing Enterprise License.
常用英文縮寫
英文縮寫 英 文 中 文 翻 譯
一、機構
CAC Codex Alimentarius Committee (國際)食品法典委員會
CBER FDA Center for Biologics Evaluation
and Research (美國)FDA生物制品評價與研究中心
CCD Certification Committee for Drugs (國家食品藥品監督管理局)藥品認證管理中心
CDC Centers for Disease Control (美國)疾病控制中心
CDE Center for Drug Evaluation (國家食品藥品監督管理局)藥品審評中心
CDER FDA Center for Drug Evaluation and
Research (美國)FDA藥品評價與研究中心
CDR Center for Drug Reevaluation (國家食品藥品監督管理局)藥品評價中心
CDRH FDA Center for Devices and
Radiological Health (美國)FDA醫療器械和輻射健康中心
CFSAN FDA Center for Food Safety and
Applied Nutrition (美國)FDA食品安全和應用營養中心
CMA Chinese Medical Association 中華醫學會
CNAO National Audit Office of the People's
Republic of China 中華人民共和國審計署
CNMA China Nonprescription Medicines
Association 中國非處方藥協會
CPA China Pharmaceutical Association 中國藥學會
CPMA China Preventive Mediceine
Association 中華預防醫學會
CVM FDA Center for Veterinary Medicine (美國)FDA獸藥中心
DEA Drug Enforcement Administration (美國)毒品強制執行管理局
DHHS Department of Health and Human
Services (美國)健康和人類服務部
EFSA European Food Safety Authority 歐洲食品安全局
EMEA European Agency for the Evaluation of Medicinal Products 歐洲藥品評價署
EPA Environmental Protection Agency (美國)環境保護署
EU European Union 歐盟
FAO United Nations Food and Agricultural Organization 聯合國糧農組織
FDA Food and Drug Administration (美國)食品藥品管理局
FSIS Food Safety Inspection Service
(USDA) (美國農業部)食品安全檢查服務局
FTC Federal Trade Commission (美國)聯邦貿易委員會
ICH International Conference on
Harmonization 國際(藥品注冊)協調會議
IMIC International Medical Information
Center 國際醫學信息中心
INCB International Narcotics Control Board 國際麻醉藥品管制局
IOM Institute of Medicine (美國國家科學院)醫學研究所
IPF International Pharmaceutical
Federation 國際制藥聯合會
IRC International Red Cross 國際紅十字會
IRCC International Red Cross Conference 國際紅十字大會
ISO International Standards Organization 國際標準化組織
IVDC China Institute of Veterinary Drug
Control 中國獸醫藥品監察所
JIFSAN Joint Institute for Food Safety and
Applied Nutrition (美國FDA)食品安全和應用營養聯合研究所
KFDA Korea Food and Drug Administration (韓國)食品藥品管理局
MHLW Ministry of Health, Labour and Welfare (日本)厚生勞動省
MII China Ministry of Information Industry 中華人民共和國信息產業部
MOF Ministry of Finance People's Republic of China 中華人民共和國財政部
MoH Ministry of Health P.R.China 中華人民共和國衛生部
MOST Ministry of Science and Technology of
the People's Republic of China 中華人民共和國科學技術部
NBS National Bureau of Statistics of China 國家統計局
NCI National Cancer Institute (美國)國家癌癥研究所
NCTR FDA National Center for Toxicological
Research (美國)FDA國家毒理學研究中心
NIAID National Institute of Allergy and
Infectious Diseases (美國)國家過敏癥和傳染病研究所
NICPBP National Institute for the Control of
Pharmaceutical and Biological
Products 中國藥品生物制品檢定所
NIDA National Institute on Drug Abuse (美國)國家藥物濫用研究所
NIH National Institute of Health (美國)國家健康研究所
ORA FDA Office of Regulatory Affairs (美國)FDA監管事務辦公室
PHS Public Health Service (美國)公眾健康服務局
PRC People's Republic of China 中華人民共和國
SAIC State Administration For Industry &
Commerce 國家工商行政管理總局
SAMHSA Substance Abuse and Mental Health
Services Administration (美國)物質濫用和精神健康服務管理局
SATCM State Administration of Traditional
Chinese Medicine (中國)國家中醫藥管理局
SETC State Economic and Trade
Commission，PRC 中華人民共和國國家經濟貿易委員會
SFDA State Food and Drug Administration (中國)國家食品藥品監督管理局
SIPO State Intellectual Property Office of the People's Republic of China 國家知識產權局
TFDA Thailand Food and Drug
Administration (泰國)食品藥品管理局
TGA Therapeutic Goods Administration (澳大利亞)治療產品管理局
UK United Kingdom (大不列顛)聯合王國
USDA Unites States Department of
Agriculture 美國農業部
WHO United Nations World Health
Organization (聯合國)世界衛生組織
WTO World Trade Organization 世界貿易組織
ZDA Zhejiang Drug Administration 浙江省藥品監督管理局
The Ministry of Agriculture of the
People's Republic of China 中華人民共和國農業部
Ministry of Commerce of the People's
Republic of China 中華人民共和國商務部
National Population and Family
Planning Commission of China 國家人口和計劃生育委員會
State Administration of Taxation of
China 國家稅務總局
Chinese Center for Disease Control
and Prevention 中國疾病預防控制中心
National Center for Health Inspection
and Supervision 衛生部衛生監督中心
The National Center for Drug
Screening 國家新藥篩選中心
National Committee on the Assessment
of the Protected Traditional Chinese
Medicinal Products P.R.C. 國家中藥品種保護評審委員會
National Development and Reform
Commission 中華人民共和國國家發展和改革委員會
Ministry of Justice P.R.C 中華人民共和國司法部
二、國家、首都和地區(部分)
AUST Australia 澳大利亞
Canberra 堪培拉
Aut Austria 奧地利
Wienna 維也納
Bra Brazil 巴西
Brasilia 巴西利亞
Brit Britain 英國
London 倫敦
Can Canada 加拿大
Ottawa 渥太華
Ch China 中國
Beijing 北京
Fra France 法國
Paris 巴黎
Ger Germany 德國
Berlin 柏林
Hol Holland 荷蘭
Amsterdam 阿姆斯特丹
Ind India 印度
New Delhi 新德里
Indon Indonesia 印度尼西亞
Jakarta 雅加達
Ir Irag 伊拉克
Baghdad 巴格達
Ir Ireland 愛爾蘭
Dublin 都柏林
Ital Italy 意大利
Roma 羅馬
J Japan 日本
Tokyo 東京
Kor Korea 朝鮮
Pyongyang 平壤
Kuw Kuwait 科威特
Kuwait City 科威特城
Pg Portugal 葡萄牙
Lisbon 里斯本
Pna Panama 巴拿馬
Ciudad de Panama 巴拿馬城
Pol Poland 波蘭
Warsaw 華沙
Russ Russian 俄羅斯
Moscow 莫斯科
Sp Spanish 西班牙
Madrid 馬德里
SIN Singapore 新加坡
Swit Switzerland 瑞士
Berne 伯爾尼
U.S. United States of America 美國
Washington 華盛頓
Mac Macao 澳門
Mil Milan (意)米蘭
Tib Tibet 西藏
TW Taiwan 臺灣
HK Hongkong 香港
Hma Hiroshima (日)廣島
EU European Union 歐盟
三、貨幣(部分)
AUD Australia Dollar 澳洲元
CAD Canada Dollar 加拿大元($)
Fr. Franc 法郎
RMB Renminbi Yuan 人民幣元（￥）
EUR Euro 歐元
GBP British Pound 英鎊(￡)
HKD Hong Kong Dollar 港元($)
JPY Japanese Yen 日圓（￥）
Lit Lira 里拉
M Mark 馬克
MYR Malaysian Ringgit 馬來西亞元($)
NZD New Zealand Dollar 紐西蘭元
SGD Singapore yuan 新加坡元($)
SWK Swedish Krona 瑞典克朗
THB Thai Baht 泰國幣
TWD Taiwan new Dollar 新臺幣
USD U.S.dollar 美元（＄）
四、醫學藥學名詞
510(k) Premarket Notification For Medical Devices Substantially Equivalent To Products Already On The Market 對實質等效于已上市產品的醫療器械的上市前通知
AAD Atherosclerotic Arterial Disease 動脈粥樣硬化病
AADA Abbreviated Antibiotic Drug
Application 簡化抗生素藥品申請
AA-DS Acute Arthritis-Dermatitis Syndrome 急性關節炎－皮炎綜合癥
AAE Acute Allergic Encephalitis 急性過敏性腦炎
AAM Acute Aseptic Meningitis 急性無菌性腦膜炎
AAR Active Avoidance Reaction 主動回避反應
AARIT Antigen-Antibody Reaction Inhibition
Test 抗原－抗體反應抑制試驗
AAT Acute Abdominal Tympany 急性腹脹
ABE Acute Bacterial Endocarditis 急性細菌性心內膜炎
ABMR Autologous Bone Marrow Rescue 自身骨髓解救
ABO Blood Classification System 血液分類系統
ABP Antigen-Blinding Protein 抗原結合蛋白
ABS Aging Brain Syndrome 老年腦綜合癥
ACAD Asymptomatic Coronary Artery Disease 無癥狀性冠狀動脈疾病
A-CAH Autoimmune Chronic Active Hepatitis 自身免疫慢性活動性肝炎
ACPP Adrenocortical Polypeptide 腎上腺皮質多肽
ADE Adverse Drug Event 不良藥品事件；藥品不良事件
ADR Adverse Drug Reaction 不良藥品反應；藥品不良反應
ADR Adverse Drug Report 不良藥品報告；藥品不良反應報告
AERS Adverse Events Reporting System 不良事件報告系統
AHG Antihemophilic Globulin 抗血友病球蛋白
AHA Acute Hemolytic Anemia 急性溶血性貧血
AHAB American Health Information Bank 美國衛生信息庫
AIDS Acquired Immune Deficiency Syndrome 獲得性免疫缺乏綜合癥；愛滋病
ANDA Abbreviated New Drug Application 簡化新藥申請
ASCT Autologous Stem Cell Transplan-Tation 自體干細胞移植
ATP Adenosine Triphosphate 三磷酸腺甘
BIMO Bioresearch Monitoring 生物研究監測
BLA Biologic License Application 生物制品許可申請
BP British Pharmacopoeia 《英國藥典》
BSE Bovine spongiform encephalopathy
(mad cow disease) 牛海綿狀腦病(瘋牛病)
CGMPs Current good manufacturing practices 現行良好制造規范；現行藥品生產質量管理規范
CJD Creutzfeldt-Jakob disease 克雅氏病
COS Certificate of Suitability (《歐洲藥典》)適用性證書
CP The Pharmacopoeia of the PRC 《中國藥典》
CY Calendar year (January - December) 歷年(1月—12月)
D/S Dextrose/saline 葡萄糖鹽水
DCBF Dyamic cardiac blood flow 心動態流血
DCPC Deacetyl cephalosporin C 脫乙酰頭孢菌素C
DD Dangerous drug 危險藥品
DDA Dangerous Drugs Act 危險藥品法
DDC Dangerous drug cabinet 危險藥品柜
DDD Defined daily dose 規定的每日劑量
DDp Drug dependence 藥物依賴性(藥癮)
DD-SF Delayed dose sensitive feedback 藥物劑量延遲反饋
DDx Differential diagnosis 鑒別診斷
DE Drug evaluation 藥品評價
DE Dose equivalent 等價劑量；劑量當量（放射）
DI Drug interactions 藥物相互作用
DIC Drug information center 藥品信息中心
DID Drug induced disease 藥品誘發疾病；藥源性疾病
DIF Dose increase factor 劑量增加因素
DME Drug-metabolizing enzyme 藥物代謝酶
DMF Durg master file 藥品主文件
DNA Deoxyribonucleic acid 脫氧核糖核酸
DSHEA Dietary Supplement Health and
Education Act 《飲食補充劑健康與教育法》
DUR Drug utilization review 藥物利用評價
DUR Drug use review 藥物使用評論
EFA Essential fatty acid 必需脂肪酸
EHC Essential hypercholesterolemia 原發性高膽固醇血癥
EIA Enzyme immunoassay 酶免疫分析
ELA Establishment license application 機構許可申請
ELISA Enzyme-linked immunosorbent assay 酶聯免疫吸附測定
EP European pharmacopoeia 《歐洲藥典》
FD&C Act Federal Food, Drug and Cosmetic Act 《聯邦食品、藥品和化妝品法》
FDAMA Food and Drug Administration
Modernization Act of 1997 《1997年食品藥品管理局現代化法》
FIA Fluorescence immunoassay 熒光免疫分析
FLQ Fluoroquinolone 氟喹諾酮
FPIA Fluorescence polarization immunoassay 熒光偏振免疫分析
FPLA Fair Packaging and Labeling Act 《公平包裝與標識法》
FSOT Fused-silica open tubular column 熔融二氧化硅空心柱
FY Fiscal year (October - September) 財政年度(10月—9月)
GAPs Good agricultural practices 良好農業規范；中藥材生產質量管理規范
GATT General Agreement on Tariffs and Trade 《關稅與貿易總協定》
GCP Good clinical practice 良好臨床規范；藥品臨床研究質量管理規范
GDP Good dispensing practice 良好調配規范；
GF Growth factor 生長因子
GLP Good laboratory practice 良好實驗室規范；藥品非臨床研究質量管理規范
GMP Good manufacturing practices 藥品生產和管理規范
GPP Good pharmacy practice 良好藥房規范；醫療機構制劑配制管理規范
GPSP Good Post-marketing Surveillance
Practice 良好上市后監督規范；上市藥品監督規范
GRAS Generally Recognized as Safe food
ingredients 公認安全的食品成分
GSP Good supplying practice 良好供應規范；藥品經營質量管理規范
HACCP Hazard Analysis Critical Control Points (a quality assurance and inspection technique) 危害分析與關鍵控制點(一種質量保證和檢查技術)
HAR Hemoagglutination reaction 血細胞凝集反應
HARM Heparin assay rapid method 肝素快速測定方法
HAs Highest asymptomatic dose 最大無癥狀劑量
HIV Human immunodeficiency virus 人免疫缺陷病毒
HPLC High-performance liquid
chromatography 高效液相色譜法
HTD Human therapeutic dose 人治療劑量
IAIS Insulin autoimmune syndrome 胰島素自體免疫綜合癥
IAN Idiopathic aseptic necrosis 自發性無菌性壞死
IBQ Illness behavior questionnaire 病態行為調查表
IBV Infectious bronchitis vaccine 感染性支氣管炎疫苗
ICF Intensive care facility 重癥監護設施
ICF Intensive care facility 重癥監護設施
Icx Immune complex 免疫復合體
IIS Intensive immunosuppression 加強免疫抑制（法）
IMBC Indirect maximum breathing capacity 間接最大呼吸量
IND Investigational new drug 研究用新藥
INN International nonproprietary name 國際非專有藥名
IRTU Integrating regulatory transcription unit 整合調解轉錄單位
IS Immune serum 免疫血清
ISD Immunosuppressive drug 免疫抑制劑
IT Information technology 信息技術
IU International unit 國際單位
Ksp Solubility product 可溶性產物
LACF Low acid canned foods 低酸罐裝食品
LAN Local area network 局域網；局部區域網絡
LC50 Median lethal concentration 半數致死濃度
LD50 Median lethal dose 半數致死量
LFD Least fatal dose 最低致死劑量
LIE Liquid ion evaporation 液體離子蒸發
M&M Morbidity and mortality 發病率和死亡率
MAO Maximal acid output 最大酸輸出量
MAR Maximal aggregation ratio 最大聚集率
MAS Medical advisory service 醫療咨詢服務
MB Microbiological assay 微生物鑒定
MDG Mean diastolic gradient 平均收縮梯度
MDR Medical Device Reporting system 醫療器械報告系統
MIC Minimun inhibitory concentration 最低抑菌濃度
MIC50 50％ minimun inhibitory concentration 50％最低抑菌濃度
MIC90 90％ minimun inhibitory concentration 90％最低抑菌濃度
MID Minimum infective dose 最小感染劑量
MIP Maximum inspiratory pressure 最大吸氣壓
MLC Minimum lethal concentration 最小致死濃度
MLD Minimum lethal dose 最小致死量
MMEF Maximum midexpiratory flow 最大呼氣中期流量
MND Minimum necrosing dose 最小壞死劑量
MOU Memorandum of Understanding 諒解備忘錄
MPO Maximum power output 最大能量的輸出量
MQSA Mammography quality standards act 《乳房X線造影術質量標準法》
MRA Mutual recognition agreement 互認協議
MRFIT Multiple risk factor interviention trial 多種危險因子干擾試驗
MRSA Methicillin resistant Staphylococcus aureus 抗甲氧西林金黃色葡萄球菌
MTC Maximum talerated concentration 最大耐受濃度
MTD Maximum tolerated dose 最大耐受劑量
MTI Minimum time interval 最低間隔時間
N.F. National formulary 《(美國)國家處方集》
NAFTA North atlantic free trade agreement 《北大西洋自由貿易協議 》
NARMS National antimicrobial resistance
monitoring system 國家耐抗菌素監測系統
NCP Noncollagen protein 非膠原蛋白
NDA New drug application 新藥申請
NDR Normal daily requirement 每日正常需要量
NETD Non-equilibrium temperature difference 非平衡溫差
NFD Nonfatal disease 非致死性疾病
NGF Nerve growth factor 神經生長因子
NIBP Noninvasive blood pressure 非侵入性血壓
NID Nonimmunological disease 非免疫性疾病
NIDA Nutritional iron defeciency anemia 營養性缺鐵性貧血
NIR Nosocomial infection rate 醫院感染率
NK Natural killer (cell) 自然殺傷細胞
NKDA No known drug allergies 未知的藥物過敏癥
NKFA No known food allergies 未知的食物過敏癥
NLEA Nutrition Labeling and Education Act 《營養標識與教育法》
NME New molecular entity 新分子實體
NMR Neonatal mortality rate 新生兒死亡率
NNF Nonnutritive fiber 無營養纖維
NNS Nonneoplastic syndrome 非腫瘤性綜合癥
NOED Non-observed effect dose 無毒性效應劑量
NOHL Non-organic hearing loss 非器質性耳聾
NP Nordic pharmacopoeia 《北歐藥典》
NPD Normal protein diet 正常蛋白飲食
NPN Non-protein nitrogen 非蛋白氮
NQAA Nonquantitative absorption assay 非定量吸收測定
OASIS Operational and Administrative System for Import Support 進口支持的運作和管理系統
OTC Over the counter drug (Nonprescription drugs) 放在柜臺上的藥品(非處方藥)
OTC Over-the-counter 上柜；非處方
PAGE Polyacrylamide gel electrophoresis 聚丙烯酰胺凝膠電泳
PCA Principal component analysis 主成分分析
PCR Polymerase chain reaction 聚合酶鏈反應
PDMS Plasma desorption mass spectrometry 等離子體解吸質譜法
PDUFA Prescription Drug User Fee Act of 1992 《1992年處方藥用戶費法》
PE Pharmacoeconomica 藥物經濟學
Ph Gal Pharmacopoeia galisa 《法國藥典》[拉]
Ph J Pharmacopoeia japonica 《日本藥典》
PHA Phytohemagglutinin 植物凝集素
PhI Pharmacopoeia internationalis 《國際藥典》[拉]
PL Phospholipid 磷脂
PLA Product license application 產品許可申請
PMA Premarket Approval (Application to
market medical device that requires
premarket approval) 上市前批準(要求上市前批準的醫療器械的上市申請)
PMS Postmarking surveilance 上市后監督
PPP Platelet poor plasma 貧血小板血漿
PRP Platelet rich plasma 富血小板血漿
PT Prothrombin time 凝血酶原時間
QA Quality assurance 質量保證
QC Quality control 質量控制
QSAR Quantitative structure activity
relationship 定量構效關系
R&D Research and development 研究與開發
RA Rheumatoid arthritis 類風濕性關節炎
RCHSA Radiation Control for Health and Safety
Act 《為健康和安全的輻射控制法》
RF Replicating form 復制性
RIA Radioimmunoassay 放射免疫測定
RNA Ribonucleic acid 核糖核酸
SAB Serum albumin 血清白蛋白
SARS Severe acute respiratory syndrome 嚴重急性呼吸道綜合癥
SCE Sister chromatid exchange 姐妹染色體互換
SE Salmonella enteriditis 沙門氏菌
SOP Standard operating procedure 標準操作規程
TB Tuberculosis 結核病
TD50 Median toxic dose 半數中毒量
TPN Total parenteral nutrition 全腸外營養
TQC Total quality control 全面質量控制
USP The united states pharmacopoeia 《美國藥典》
五、傳染病
AIDS Acquired immune deficiency syndrome 獲得性免疫缺陷綜合癥；艾滋病
cho Cholera 霍亂
Cp Chicken pox 水痘
diph Diphtheria 白喉
ECM Epidemic cerebrospinal meningitis 流行性腦脊髓膜炎
EHF Epidemic hemorrhagic fever 流行性出血熱
Gono Gonorrhea 淋病
IB Infectivity bronchitis 感染性支氣管炎
JBE Japanese B encephalitis 流行性乙型腦炎；日本B型腦炎
P Plague 鼠疫
Polio Poliomyelitis 脊髓灰質炎；小兒麻痹癥
PT Pulmonary tuberculosis 肺結核
Rab Rabies 狂犬病
SARS Severe acute respiratory syndrome 嚴重急性呼吸道綜合癥
SF Scarlet fever 猩紅熱
SY Syphilis 梅毒
TB Tuberculosis 結核病
Ty Typhoid 傷寒
VH Viral hepatitis 病毒性肝炎
Vl Visceral leishmaniasis 黑熱病，又稱內臟利什曼病
WC Whooping cough 百日咳
Anthracnose 炭疽病
Shigellosis 細菌性痢疾，志賀菌病
Paratyphoid fever 副傷寒
Measles；rubeola；morbill 麻疹
Typhus fever；Typhus 斑疹傷寒
Paludism；malaria 瘧疾
Breakbone fever；dengue fever 登革熱
Tetanus of newborn 新生兒破傷風
六、化驗單
ALB Albumin 白蛋白
ALP Alkaline phosphatase 堿性磷酸酶
APO Apolipoprotein 載脂蛋白
BIL Bilirubin 膽紅素
BT Bleeding time 出血時間
CHO Cholesterol 膽固醇
CT Clotting time 血塊形成時間
CT Coagulation time 凝固時間
D-BIL Direct bilirubin 直接膽紅素
er Erythrocyte 紅細胞
GLU Glucose 葡萄糖
GOT Glutamic-oxal(o)acetic transaminase 谷草轉氨酶
GPT Glutamic-pyruvic transaminase 谷丙轉氨酶
GT Glutamyl transpeptidase 谷氨酰轉肽酶
HDLC High-density lipoprotein 高密度脂蛋白
hem Hemoglobin 血紅蛋白
LAP Leucine aminopeptidase 亮氨酸氨基肽酶
LDL Low-density lipoprotein 低密度脂蛋白
LF Liver function test 肝功能試驗
PhoH Phosphorus 磷
PL Platelet 血小板
pr Protein 蛋白質
SI Serum iron 血清鐵
TBA Total bile acid 總膽汁酸
Tca Total calcium 總鈣
TP Total protein 總蛋白
trig Triglycerides 甘油三酯
UA Uric acid 尿酸
Blood cell;hemocyte 血細胞
Erythrocyte sedimentation 血沉；紅細胞沉降
七、處方
Aq Aqua 水劑[拉]
Cap Capsule 膠囊
DPI Drug prescription index 藥物處方指數
emp Empladstrum 貼膏劑[拉]
INF Infusion 灌注
Inj Injection 注射
IV drop Intravenous drop infusion 靜脈滴注
IVP Intravenous push 靜脈推注
Lot Lotion 擦劑
Mist Mistura 合劑[拉]
Rx Prescription 處方[拉]
SI Saline infusion 生理鹽水灌注
SI Saline injection 生理鹽水注射
Sol Solution 溶液
Syr Syrup 糖漿
Tab Tablet 片劑
tr Tincture 酊劑
Ung Unguent 軟膏
Subcutaneous injection 皮下注射
Intramuscular injection 肌內注射
External use 外用
八、法律術語
a Action 訴訟
ARB Arbitration 仲裁
c.l. Civil law 民法
cl. Clause 條款
IP Import permit 進口許可證
rec Reclamation 索賠，要求賠償損失
ref Referee 仲裁人，鑒定人，受委托者
Reg. Regulations 規則，條例
Reg.No. Registered number 注冊號，登記的號
repr Representative 代理人，繼承人
resp Respond 承擔責任
sup Supplement 附加（補充）條款
Sup Ct Supreme court 最高法院
Absolute discharge 無條件釋放
Acquire title to the objects 就標的物取得權利
Act of tort 侵權行為
Administered prices 控制價格
Administrative penalty 行政處罰
Administrative regulations 行政法規
Alimony 贍養費
Body corporate 法人團體
Business aggrement 業務協定
Circuit of action 巡回訴訟
Civil action 民事訴訟
Civil legal relations 民事法律關系
Civil sanctions 民事制裁
Contraband of import 非法進口
Contract of sales 銷售合同
Econmic dispute 經濟糾紛
Franchise 經銷權；特許權
Fraud or any other unlawful means 欺騙或其它非法手段
Illegal drug 非法藥品
Instrument of ratification 批準書
Interested party 厲害關系人
Juristic person 法人
Labour protection 勞動保護
Legal basis 法律根據
Legal provisions 法律規定
Legal relation 法律關系
Legal system 法制
Legislation on labour protection 勞動保護法規
Legislature organ 立法機關
Licence 許可證；特許證
Mediate a dispute 排解糾紛
Not to be charged 免予起訴
Price control 價格控制
Processing of investor's raw materials 來料加工
Prosecutor 起訴人
Remote damege 間接損害
Trade agreement 貿易協定
Without obligation 解除責任
九、WTO相關術語
AMS Aggregate Measure of Support 綜合支持量
B/L Bill of lading 提單
C.O Certificate of origin 一般原產地證
C/D Customs declaration 報關單
CFR Cost and freight 成本加運費價
CIF Cost,insurance&freight 成本、保險加運費價
CTN/CTNS Carton/cartons 紙箱
D/A Document against acceptance 承兌交單
D/P Document against payment 付款交單
DPV Duty paid value 完稅后貨物總價；完稅后價值
DSB Dispute settlement body 爭端解決機構
EMS Express mail special 特快傳遞
EXP Export 出口
G.S.P. Generalized system of preferences 普惠制
IMP Import 進口
L/C Letter of credit 信用證
MFN Most favored nation 最惠國待遇
OECD Organization for Economic Cooperation and Development 經濟合作與發展組織
P/L Packing list 裝箱單、明細表
S/C Sales contract 銷售確認書
TBT Technical Barrier to Trade 貿易技術壁壘
TRO Tariff-rate Quota 關稅配額
URAA Agreement on Agriculture 農業協議
Article of General Agreement on Tariffs and Trade 關貿總協定條款
Agreement on Import Procedures 進口許可程序協議
Agreement on Preshipment Inspection 裝運前檢驗協議
Agreement on Safeguards 保障措施協議
Agreement on Technical Barriers to
Trade 技術貿易壁壘協議
Blue box policies 藍箱政策
Bound tariff rates 約束稅率
Country schedules 國家減讓表
Market access 市場準入
Non-tariff trade barriers 非關稅貿易壁壘
Notification process 通知程序
Special and differential treatment 特殊差別待遇
Tariff 關稅
Tariffication 關稅化