常 用 藥 品 監(jiān) 管 英 語(yǔ) 與 縮 略 語(yǔ)

zhaoyuyong

常 用 藥 品 監(jiān) 管 英 語(yǔ) 與 縮 略 語(yǔ)
                           一、監(jiān)管英語(yǔ)
1.《中華人民共和國(guó)藥品管理法》
Drug Control Law of the People's Republic of China

2.藥品生產(chǎn)企業(yè)管理
control over drug manufacturers

3.藥品經(jīng)營(yíng)企業(yè)管理
control over drug distributors

4.醫(yī)療機(jī)構(gòu)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(jià)格和廣告的管理
control over drug price and advertisement

8.藥品監(jiān)督
inspection of drugs

9.法律責(zé)任
legal liabilities

10.藥品標(biāo)識(shí)
labels or marks of the drugs

11.假藥
counterfeit drugs

12.劣藥
inferior drugs

13.藥品檢驗(yàn)機(jī)構(gòu)
drug quality control laboratory

14.藥品的生產(chǎn)企業(yè)
drug manufacturers

15.經(jīng)營(yíng)企業(yè)
drug distributors

16.醫(yī)療機(jī)構(gòu)
medical institutions

17.藥品監(jiān)督管理部門(mén)
drug regulatory agency

18.藥品批準(zhǔn)證明文件
drug approval documents

19.行政處分
administrative sanctions

20.刑事責(zé)任
criminal liabilities

21.藥品生產(chǎn)質(zhì)量管理規(guī)范
Good Manufacturing Practice for Pharmaceutical Products (GMP)

22.藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范
Good Supply Practice for Pharmaceutical Products (GSP)

23.藥品生產(chǎn)許可證
Drug Manufacturing Certificate

24.藥品經(jīng)營(yíng)許可證
Drug Supply Certificate

25.醫(yī)療機(jī)構(gòu)制劑許可證
Pharmaceutical Preparation Certificate for Medical Institution

26.進(jìn)口藥品注冊(cè)證書(shū)
Import Drug License

27.臨床試驗(yàn)
clinical trial

28.新藥證書(shū)
New Drug Certificate

29.藥品批準(zhǔn)文號(hào)
Drug Approval Number

30.在中華人民共和國(guó)境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營(yíng)、使用和監(jiān)督管理的單位或者個(gè)人，必須遵守《中華人民共和國(guó)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(guó)務(wù)院藥品監(jiān)督管理部門(mén)主管全國(guó)藥品監(jiān)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(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)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(jiān)督管理部門(mén)設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)，承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)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(kāi)辦藥品生產(chǎn)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)并發(fā)給《藥品生產(chǎn)許可證》，憑《藥品生產(chǎn)許可證》到工商行政管理部門(mén)辦理登記注冊(cè)。
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(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)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(jiān)督管理部門(mén)批準(zhǔn)開(kāi)辦藥品生產(chǎn)企業(yè)，應(yīng)當(dāng)符合國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。
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(kāi)辦藥品生產(chǎn)企業(yè)，必須具備以下條件：（一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；（二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；（三）具有能對(duì)所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備；（四）具有保證藥品質(zhì)量的規(guī)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(chǎn)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門(mén)依據(jù)本法制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。藥品監(jiān)督管理部門(mén)按照規(guī)定對(duì)藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書(shū)。
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(guó)家藥品標(biāo)準(zhǔn)和國(guó)務(wù)院藥品監(jiān)督管理部門(mén)批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)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(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的，必須報(bào)原批準(zhǔn)部門(mén)審核批準(zhǔn)。
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(chǎn)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(chǎn)企業(yè)必須對(duì)其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗(yàn)。
Drug manufacturers shall perform quality test of their products.

43.不符合國(guó)家藥品標(biāo)準(zhǔn)或者不按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)制定的中藥飲片炮制規(guī)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(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門(mén)或者國(guó)務(wù)院藥品監(jiān)督管理部門(mén)授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)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(kāi)辦藥品批發(fā)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)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(kāi)辦藥品零售企業(yè)，須經(jīng)企業(yè)所在地縣級(jí)以上地方藥品監(jiān)督管理部門(mén)批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)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(fā)、零售企業(yè)憑《藥品經(jīng)營(yíng)許可證》到工商行政管理部門(mén)辦理登記注冊(cè)。
With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and commerce.

47.無(wú)《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。
No one is permitted to distribute drugs without the certificate.

48.《藥品經(jīng)營(yíng)許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營(yíng)范圍，到期重新審查發(fā)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(kāi)辦藥品經(jīng)營(yíng)企業(yè)必須具備以下條件： （一）具有依法經(jīng)過(guò)資格認(rèn)定的藥學(xué)技術(shù)人員；（二）具有與所經(jīng)營(yíng)藥品相適應(yīng)的營(yíng)業(yè)場(chǎng)所、設(shè)備、倉(cāng)儲(chǔ)設(shè)施、衛(wèi)生環(huán)境；（三）具有與所經(jīng)營(yíng)藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員；（四）具有保證所經(jīng)營(yíng)藥品質(zhì)量的規(guī)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(jīng)營(yíng)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門(mén)依據(jù)本法制定的《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)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(jiān)督管理部門(mén)按照規(guī)定對(duì)藥品經(jīng)營(yíng)企業(yè)是否符合《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書(shū)。
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(jīng)營(yíng)企業(yè)購(gòu)進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)。
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(jīng)營(yíng)企業(yè)購(gòu)銷(xiāo)藥品，必須有真實(shí)完整的購(gòu)銷(xiāo)記錄。
Drug distributors shall keep a real and perfect records of purchasing and selling drugs.

54.購(gòu)銷(xiāo)記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號(hào)、有效期、生產(chǎn)廠商、購(gòu)（銷(xiāo)）貨單位、購(gòu)（銷(xiāo)）貨數(shù)量、購(gòu)銷(xiāo)價(jià)格、購(gòu)（銷(xiāo)）貨日期及國(guó)務(wù)院藥品監(jiān)督管理部門(mén)規(guī)定的其他內(nèi)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(jīng)營(yíng)企業(yè)銷(xiāo)售中藥材，必須標(biāo)明產(chǎn)地。
Drug distributors shall indicate the habitat of Chinese crude drugs to be sold.

56.藥品經(jīng)營(yíng)企業(yè)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲(chóng)、防鼠等措施，保證藥品質(zhì)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(kù)和出庫(kù)必須執(zhí)行檢查制度。
An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse.

58.城鄉(xiāng)集市貿(mào)易市場(chǎng)可以出售中藥材，國(guó)務(wù)院另有規(guī)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(xiāng)集市貿(mào)易市場(chǎng)不得出售中藥材以外的藥品，但持有《藥品經(jīng)營(yíng)許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場(chǎng)設(shè)點(diǎn)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(yī)療機(jī)構(gòu)配制制劑，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門(mén)審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)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(wú)《醫(yī)療機(jī)構(gòu)制劑許可證》的醫(yī)療機(jī)構(gòu)，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(yī)療機(jī)構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)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(yī)療機(jī)構(gòu)配制的制劑，應(yīng)當(dāng)是本單位臨床需要而市場(chǎng)上沒(méi)有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)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(yī)療機(jī)構(gòu)配制的制劑，不得在市場(chǎng)銷(xiāo)售。
No pharmaceutical preparations dispensed by medical institutions are permitted to be marketed.

65.研制新藥，必須按照國(guó)務(wù)院藥品監(jiān)督管理部門(mén)的規(guī)定如實(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門(mén)批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。
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(yàn)并通過(guò)審批的新藥，由國(guó)務(wù)院藥品監(jiān)督管理部門(mén)批準(zhǔn)，發(fā)給新藥證書(shū)。
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(píng)價(jià)研究機(jī)構(gòu)和臨床試驗(yàn)機(jī)構(gòu)必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)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(chǎn)新藥或者已有國(guó)家標(biāo)準(zhǔn)的藥品的，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門(mén)批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號(hào)；但是，生產(chǎn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)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(shí)施批準(zhǔn)文號(hào)管理的中藥材、中藥飲片品種目錄由國(guó)務(wù)院藥品監(jiān)督管理部門(mén)會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門(mén)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(chǎn)企業(yè)在取得藥品批準(zhǔn)文號(hào)后，方可生產(chǎn)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(guó)家藥品標(biāo)準(zhǔn)。
Drugs shall comply with the National Drug Standards.

72.國(guó)務(wù)院藥品監(jiān)督管理部門(mén)頒布的《中華人民共和國(guó)藥典》和藥品標(biāo)準(zhǔn)為國(guó)家藥品標(biāo)準(zhǔn)。
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(guó)務(wù)院藥品監(jiān)督管理部門(mén)組織藥典委員會(huì)，負(fù)責(zé)國(guó)家藥品標(biāo)準(zhǔn)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(guó)務(wù)院藥品監(jiān)督管理部門(mén)的藥品檢驗(yàn)機(jī)構(gòu)負(fù)責(zé)標(biāo)定國(guó)家藥品標(biāo)準(zhǔn)品、對(duì)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(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營(yíng)資格的企業(yè)購(gòu)進(jìn)藥品；但是，購(gòu)進(jìn)沒(méi)有實(shí)施批準(zhǔn)文號(hào)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(guó)家對(duì)麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)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(guó)家實(shí)行中藥品種保護(hù)制度。
The State adopts a protection system for certain traditional Chinese medicines.

78.國(guó)家對(duì)藥品實(shí)行處方藥與非處方藥分類(lèi)管理制度。
The State adopts a system of classified management for prescription and non-prescription drugs.

79.藥品進(jìn)口，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門(mén)組織審查，經(jīng)審查確認(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊(cè)證書(shū)。
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(guó)家實(shí)行藥品儲(chǔ)備制度。
The State adopts a policy for drug storage for future use.

81.國(guó)內(nèi)發(fā)生重大災(zāi)情、疫情及其他突發(fā)事件時(shí)，國(guó)務(wù)院規(guī)定的部門(mén)可以緊急調(diào)用企業(yè)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(chǎn)（包括配制）、銷(xiāo)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(guó)家藥品標(biāo)準(zhǔn)規(guī)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(guó)務(wù)院藥品監(jiān)督管理部門(mén)規(guī)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(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷(xiāo)售的；
It is produced or imported without approval, or marketed without being tested, as required by the Law;
（三）變質(zhì)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(zhǔn)文號(hào)而未取得批準(zhǔn)文號(hào)的原料藥生產(chǎn)的；
It is produced by using active pharmaceutical ingredients without approval number as required by this Law;
（六）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。
The indications or functions indicated are beyond the specified scope.

85. 禁止生產(chǎn)、銷(xiāo)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(guó)家藥品標(biāo)準(zhǔn)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(biāo)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(chǎn)批號(hào)的；
The batch number is not indicated or is altered;
（三）超過(guò)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(jīng)批準(zhǔn)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(biāo)準(zhǔn)規(guī)定的。
Other cases where the drug standards are not complied with.

88.列入國(guó)家藥品標(biāo)準(zhǔn)的藥品名稱為藥品通用名稱。已經(jīng)作為藥品通用名稱的，該名稱不得作為藥品商標(biāo)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(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)直接接觸藥品的工作人員，必須每年進(jìn)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(biāo)準(zhǔn)，并由藥品監(jiān)督管理部門(mén)在審批藥品時(shí)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(guī)定印有或者貼有標(biāo)簽并附有說(shuō)明書(shū)。
A label shall be printed or stuck on the drug package with an insert sheet attached as required by regulations.

93.標(biāo)簽或者說(shuō)明書(shū)上必須注明藥品的通用名稱、成份、規(guī)格、生產(chǎn)企業(yè)、批準(zhǔn)文號(hào)、產(chǎn)品批號(hào)、生產(chǎn)日期、有效期、適應(yīng)癥或者功能主治、用法、用量、禁忌、不良反應(yīng)和注意事項(xiàng)。
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(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標(biāo)簽，必須印有規(guī)定的標(biāo)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(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)必須執(zhí)行政府定價(jià)、政府指導(dǎo)價(jià)，不得以任何形式擅自提高價(jià)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(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)在藥品購(gòu)銷(xiāo)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(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)或者其代理人以任何名義給予使用其藥品的醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購(gòu)人員、醫(yī)師等有關(guān)人員以財(cái)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(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)，并發(fā)給藥品廣告批準(zhǔn)文號(hào)；未取得藥品廣告批準(zhǔn)文號(hào)的，不得發(fā)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(guó)務(wù)院衛(wèi)生行政部門(mén)和國(guó)務(wù)院藥品監(jiān)督管理部門(mén)共同指定的醫(yī)學(xué)、藥學(xué)專(zhuān)業(yè)刊物上介紹，但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進(jìn)行以公眾為對(duì)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(nèi)容必須真實(shí)、合法，以國(guó)務(wù)院藥品監(jiān)督管理部門(mén)批準(zhǔn)的說(shuō)明書(shū)為準(zhǔn)，不得含有虛假的內(nèi)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(xué)的表示功效的斷言或者保證；不得利用國(guó)家機(jī)關(guān)、醫(yī)藥科研單位、學(xué)術(shù)機(jī)構(gòu)或者專(zhuān)家、學(xué)者、醫(yī)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(jiān)督管理部門(mén)進(jìn)行監(jiān)督檢查時(shí)，必須出示證明文件，對(duì)監(jiān)督檢查中知悉的被檢查人的技術(shù)秘密和業(yè)務(wù)秘密應(yīng)當(dāng)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(jiān)督管理部門(mén)根據(jù)監(jiān)督檢查的需要，可以對(duì)藥品質(zhì)量進(jìn)行抽查檢驗(yàn)。
Drug regulatory agencies may conduct selective testing of drug quality in light of the need of supervision and inspection.

105.抽查檢驗(yàn)應(yīng)當(dāng)按照規(guī)定抽樣，并不得收取任何費(fèi)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(jiān)督管理部門(mén)對(duì)有證據(jù)證明可能危害人體健康的藥品及其有關(guān)材料可以采取查封、扣押的行政強(qiáng)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(jiān)督管理部門(mén)應(yīng)當(dāng)按照規(guī)定，依據(jù)《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》，對(duì)經(jīng)其認(rèn)證合格的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)進(jìn)行認(rèn)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(jiān)督管理部門(mén)不得以要求實(shí)施藥品檢驗(yàn)、審批等手段限制或者排斥非本地區(qū)藥品生產(chǎn)企業(yè)依照本法規(guī)定生產(chǎn)的藥品進(jìn)入本地區(qū)。
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(guó)家實(shí)行藥品不良反應(yīng)報(bào)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(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》生產(chǎn)藥品、經(jīng)營(yíng)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(chǎn)、銷(xiāo)售假藥的，沒(méi)收違法生產(chǎn)、銷(xiāo)售的藥品和違法所得，并處違法生產(chǎn)、銷(xiāo)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(zhǔn)證明文件的予以撤銷(xiāo)，并責(zé)令停產(chǎn)、停業(yè)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(jié)嚴(yán)重的，吊銷(xiāo)《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)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(chǎn)、銷(xiāo)售劣藥的，沒(méi)收違法生產(chǎn)、銷(xiāo)售的藥品和違法所得，并處違法生產(chǎn)、銷(xiāo)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(jié)嚴(yán)重的，責(zé)令停產(chǎn)、停業(yè)整頓或者撤銷(xiāo)藥品批準(zhǔn)證明文件、吊銷(xiāo)《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)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(gòu)成犯罪的，依法追究刑事責(zé)任。
If a crime is constituted, criminal liabilities shall be investigated under the law.

113.藥品，是指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥或者功能主治、用法和用量的物質(zhì)，包括中藥材、中藥飲片、中成藥、化學(xué)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(chǎn)藥品和調(diào)配處方時(shí)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(chǎn)企業(yè)，是指生產(chǎn)藥品的專(zhuān)營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
Drug manufacturers refer to enterprises exclusively or partly engaged in drug production.

116.藥品經(jīng)營(yíng)企業(yè)，是指經(jīng)營(yíng)藥品的專(zhuān)營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
Drug distributors refer to enterprises exclusively or partly engaged in drug distribution.

117.國(guó)務(wù)院藥品監(jiān)督管理部門(mén)負(fù)責(zé)全國(guó)的醫(yī)療器械監(jiān)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(guó)家對(duì)醫(yī)療器械實(shí)行分類(lèi)管理。
The State shall carry out the policy of classification administration of medical devices.

119.國(guó)家對(duì)醫(yī)療器械實(shí)行產(chǎn)品生產(chǎn)注冊(cè)制度。
The State shall implement a product registration system for manufacturing medical devices.

120.生產(chǎn)第一類(lèi)醫(yī)療器械，由設(shè)區(qū)的市級(jí)人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊(cè)證書(shū)。
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(chǎn)第二類(lèi)醫(yī)療器械，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊(cè)證書(shū)。
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(chǎn)第三類(lèi)醫(yī)療器械，由國(guó)務(wù)院藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊(cè)證書(shū)。生產(chǎn)第二類(lèi)、第三類(lèi)醫(yī)療器械，應(yīng)當(dāng)通過(guò)臨床驗(yàn)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(yī)療器械產(chǎn)品注冊(cè)證書(shū)有效期四年。
The term of validity for the registration certificate of medical devices is four years.

124.生產(chǎn)醫(yī)療器械，應(yīng)當(dāng)符合醫(yī)療器械國(guó)家標(biāo)準(zhǔn)；沒(méi)有國(guó)家標(biāo)準(zhǔn)的，應(yīng)當(dāng)符合醫(yī)療器械行業(yè)標(biāo)準(zhǔn)。
Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.

125.醫(yī)療器械的使用說(shuō)明書(shū)、標(biāo)簽、包裝應(yīng)當(dāng)符合國(guó)家有關(guān)標(biāo)準(zhǔn)或者規(guī)定。
The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.

126.醫(yī)療器械及其外包裝上應(yīng)當(dāng)按照國(guó)務(wù)院藥品監(jiān)督管理部門(mén)的規(guī)定，標(biāo)明產(chǎn)品注冊(cè)證書(shū)編號(hào)。
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(kāi)辦第一類(lèi)醫(yī)療器械生產(chǎn)企業(yè)，應(yīng)當(dāng)向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)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(kāi)辦第二類(lèi)、第三類(lèi)醫(yī)療器械生產(chǎn)企業(yè)， 應(yīng)當(dāng)經(jīng)省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給《醫(yī)療器械生產(chǎn)企業(yè)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(yī)療器械生產(chǎn)企業(yè)許可證》有效期5年，有效期屆滿應(yīng)當(dāng)重新審查發(fā)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(yī)療機(jī)構(gòu)不得使用未經(jīng)注冊(cè)、無(wú)合格證明、過(guò)期、失效或者淘汰的醫(yī)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(yī)療器械經(jīng)營(yíng)企業(yè)不得經(jīng)營(yíng)未經(jīng)注冊(cè)、無(wú)合格證明、過(guò)期、失效或者淘汰的醫(yī)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(yī)療器械經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)從取得《醫(yī)療器械生產(chǎn)企業(yè)許可證》的生產(chǎn)企業(yè)或者取得《醫(yī)療器械經(jīng)營(yíng)企業(yè)許可證》的經(jīng)營(yíng)企業(yè)購(gòu)進(jìn)合格的醫(yī)療器械，并驗(yàn)明產(chǎn)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(yī)療機(jī)構(gòu)對(duì)一次性使用的醫(yī)療器械不得重復(fù)使用；使用過(guò)的，應(yīng)當(dāng)按照國(guó)家有關(guān)規(guī)定銷(xiāo)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(guó)家建立醫(yī)療器械質(zhì)量事故報(bào)告制度和醫(yī)療器械質(zhì)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(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門(mén)會(huì)同國(guó)務(wù)院質(zhì)量技術(shù)監(jiān)督部門(mén)認(rèn)可的檢測(cè)機(jī)構(gòu)，方可對(duì)醫(yī)療器械實(shí)施檢測(cè)。
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(yī)療器械檢測(cè)機(jī)構(gòu)及其人員對(duì)被檢測(cè)單位的技術(shù)資料負(fù)有保密義務(wù)，并不得從事或者參與同檢測(cè)有關(guān)的醫(yī)療器械的研制、生產(chǎn)、經(jīng)營(yíng)和技術(shù)咨詢等活動(dòng)。
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(duì)已經(jīng)造成醫(yī)療器械質(zhì)量事故或者可能造成醫(yī)療器械質(zhì)量事故的產(chǎn)品及有關(guān)資料，縣級(jí)以上地方人民政府藥品監(jiān)督管理部門(mén)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(yī)療器械廣告應(yīng)當(dāng)經(jīng)省級(jí)以上人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)；未經(jīng)批準(zhǔn)的，不得刊登、播放、散發(fā)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(yī)療器械廣告的內(nèi)容應(yīng)當(dāng)以國(guó)務(wù)院藥品監(jiān)督管理部門(mén)或者省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)批準(zhǔn)的使用說(shuō)明書(shū)為準(zhǔn)。
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(yī)療器械監(jiān)督管理人員濫用職權(quán)、徇私舞弊、玩忽職守，構(gòu)成犯罪的，依法追究刑事責(zé)任；尚不構(gòu)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(lèi)醫(yī)療器械是指，通過(guò)常規(guī)管理足以保證其安全性、有效性的醫(yī)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(lèi)醫(yī)療器械是指，對(duì)其安全性、有效性應(yīng)當(dāng)加以控制的醫(yī)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(lèi)醫(yī)療器械是指，植入人體；用于支持、維持生命；對(duì)人體具有潛在危險(xiǎn)，對(duì)其安全性、有效性必須嚴(yán)格控制的醫(yī)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(yī)療器械，是指單獨(dú)或者組合使用于人體的儀器、設(shè)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(nèi)的作用不是用藥理學(xué)、免疫學(xué)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(dá)到下列預(yù)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(duì)疾病的預(yù)防、診斷、治療、監(jiān)護(hù)、緩解；
（1）prevention, diagnosis, treatment, monitoring or alleviation of disease;
（二）對(duì)損傷或者殘疾的診斷、治療、監(jiān)護(hù)、緩解、補(bǔ)償；
（2）diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;
（三）對(duì)解剖或者生理過(guò)程的研究、替代、調(diào)節(jié)；
（3）investigation, replacement or regulation for anatomical or a physiological process;
（四）妊娠控制。
（4）control of conception.

145.醫(yī)療器械監(jiān)督管理?xiàng)l例
The Regulation for the Supervision and Administration of Medical Devices.

146.注冊(cè)證書(shū)
Registration certificates.

147.醫(yī)療器械生產(chǎn)企業(yè)許可證
Medical Device Manufacturing  Enterprise  License.

148.醫(yī)療器械經(jīng)營(yíng)企業(yè)許可證
Medical Device Distributing Enterprise License.


常用英文縮寫(xiě)

英文縮寫(xiě)        英  文        中 文 翻 譯
一、機(jī)構(gòu)
CAC        Codex Alimentarius Committee        (國(guó)際)食品法典委員會(huì)
CBER         FDA Center for Biologics Evaluation
and Research         (美國(guó))FDA生物制品評(píng)價(jià)與研究中心
CCD        Certification Committee for Drugs        (國(guó)家食品藥品監(jiān)督管理局)藥品認(rèn)證管理中心
CDC         Centers for Disease Control        (美國(guó))疾病控制中心
CDE        Center for Drug Evaluation        (國(guó)家食品藥品監(jiān)督管理局)藥品審評(píng)中心
CDER         FDA Center for Drug Evaluation and
Research         (美國(guó))FDA藥品評(píng)價(jià)與研究中心
CDR        Center for Drug Reevaluation        (國(guó)家食品藥品監(jiān)督管理局)藥品評(píng)價(jià)中心
CDRH         FDA Center for Devices and
Radiological Health         (美國(guó))FDA醫(yī)療器械和輻射健康中心
CFSAN         FDA Center for Food Safety and
Applied Nutrition         (美國(guó))FDA食品安全和應(yīng)用營(yíng)養(yǎng)中心
CMA        Chinese Medical Association        中華醫(yī)學(xué)會(huì)
CNAO        National Audit Office of the People's
Republic of China        中華人民共和國(guó)審計(jì)署
CNMA        China Nonprescription Medicines
Association        中國(guó)非處方藥協(xié)會(huì)
CPA        China Pharmaceutical Association        中國(guó)藥學(xué)會(huì)
CPMA        China Preventive Mediceine
Association        中華預(yù)防醫(yī)學(xué)會(huì)
CVM         FDA Center for Veterinary Medicine         (美國(guó))FDA獸藥中心
DEA        Drug Enforcement Administration        (美國(guó))毒品強(qiáng)制執(zhí)行管理局
DHHS         Department of Health and Human
Services         (美國(guó))健康和人類(lèi)服務(wù)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(píng)價(jià)署
EPA         Environmental Protection Agency         (美國(guó))環(huán)境保護(hù)署
EU         European Union         歐盟
FAO         United Nations Food and Agricultural Organization         聯(lián)合國(guó)糧農(nóng)組織
FDA        Food and Drug Administration        (美國(guó))食品藥品管理局
FSIS         Food Safety Inspection Service
(USDA)         (美國(guó)農(nóng)業(yè)部)食品安全檢查服務(wù)局
FTC         Federal Trade Commission         (美國(guó))聯(lián)邦貿(mào)易委員會(huì)
ICH         International Conference on
Harmonization         國(guó)際(藥品注冊(cè))協(xié)調(diào)會(huì)議
IMIC        International Medical Information
Center         國(guó)際醫(yī)學(xué)信息中心
INCB        International Narcotics Control Board        國(guó)際麻醉藥品管制局
IOM         Institute of Medicine         (美國(guó)國(guó)家科學(xué)院)醫(yī)學(xué)研究所
IPF        International Pharmaceutical
Federation        國(guó)際制藥聯(lián)合會(huì)
IRC        International Red Cross         國(guó)際紅十字會(huì)
IRCC        International Red Cross Conference        國(guó)際紅十字大會(huì)
ISO         International Standards Organization         國(guó)際標(biāo)準(zhǔn)化組織
IVDC        China Institute of Veterinary Drug
Control        中國(guó)獸醫(yī)藥品監(jiān)察所
JIFSAN         Joint Institute for Food Safety and
Applied Nutrition         (美國(guó)FDA)食品安全和應(yīng)用營(yíng)養(yǎng)聯(lián)合研究所  
KFDA        Korea Food and Drug Administration        (韓國(guó))食品藥品管理局
MHLW        Ministry of Health, Labour and Welfare        (日本)厚生勞動(dòng)省
MII        China Ministry of Information Industry        中華人民共和國(guó)信息產(chǎn)業(yè)部
MOF        Ministry of Finance People's Republic of China        中華人民共和國(guó)財(cái)政部
MoH        Ministry of Health P.R.China        中華人民共和國(guó)衛(wèi)生部
MOST        Ministry of Science and Technology of
the People's Republic of China        中華人民共和國(guó)科學(xué)技術(shù)部
NBS        National Bureau of Statistics of China        國(guó)家統(tǒng)計(jì)局
NCI         National Cancer Institute         (美國(guó))國(guó)家癌癥研究所
NCTR         FDA National Center for Toxicological
Research         (美國(guó))FDA國(guó)家毒理學(xué)研究中心
NIAID         National Institute of Allergy and
Infectious Diseases         (美國(guó))國(guó)家過(guò)敏癥和傳染病研究所
NICPBP        National Institute for the Control of
Pharmaceutical and Biological  
Products        中國(guó)藥品生物制品檢定所
NIDA         National Institute on Drug Abuse         (美國(guó))國(guó)家藥物濫用研究所
NIH         National Institute of Health         (美國(guó))國(guó)家健康研究所  
ORA         FDA Office of Regulatory Affairs         (美國(guó))FDA監(jiān)管事務(wù)辦公室
PHS        Public Health Service        (美國(guó))公眾健康服務(wù)局
PRC        People's Republic of China        中華人民共和國(guó)
SAIC        State Administration For Industry &
Commerce        國(guó)家工商行政管理總局
SAMHSA         Substance Abuse and Mental Health
Services Administration         (美國(guó))物質(zhì)濫用和精神健康服務(wù)管理局
SATCM        State Administration of Traditional
Chinese Medicine        (中國(guó))國(guó)家中醫(yī)藥管理局
SETC        State Economic and Trade
Commission，PRC        中華人民共和國(guó)國(guó)家經(jīng)濟(jì)貿(mào)易委員會(huì)
SFDA        State Food and Drug Administration        (中國(guó))國(guó)家食品藥品監(jiān)督管理局
SIPO        State Intellectual Property Office of the People's Republic of China        國(guó)家知識(shí)產(chǎn)權(quán)局
TFDA        Thailand Food and Drug
Administration        (泰國(guó))食品藥品管理局
TGA        Therapeutic Goods Administration        (澳大利亞)治療產(chǎn)品管理局
UK         United Kingdom         (大不列顛)聯(lián)合王國(guó)
USDA         Unites States Department of
Agriculture         美國(guó)農(nóng)業(yè)部
WHO         United Nations World Health
Organization         (聯(lián)合國(guó))世界衛(wèi)生組織
WTO         World Trade Organization         世界貿(mào)易組織
ZDA        Zhejiang Drug Administration        浙江省藥品監(jiān)督管理局
　        The Ministry of Agriculture of the
People's Republic of China        中華人民共和國(guó)農(nóng)業(yè)部
　        Ministry of Commerce of the People's
Republic of China        中華人民共和國(guó)商務(wù)部
　        National Population and Family
Planning Commission of China        國(guó)家人口和計(jì)劃生育委員會(huì)
　        State Administration of Taxation of
China        國(guó)家稅務(wù)總局
　        Chinese Center for Disease Control
and Prevention        中國(guó)疾病預(yù)防控制中心
　        National Center for Health Inspection
and Supervision        衛(wèi)生部衛(wèi)生監(jiān)督中心
　        The National Center for Drug
Screening        國(guó)家新藥篩選中心
　        National Committee on the Assessment
of the Protected Traditional Chinese
Medicinal Products P.R.C.        國(guó)家中藥品種保護(hù)評(píng)審委員會(huì)
　        National Development and Reform
Commission        中華人民共和國(guó)國(guó)家發(fā)展和改革委員會(huì)
　        Ministry of Justice P.R.C        中華人民共和國(guó)司法部
二、國(guó)家、首都和地區(qū)(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(guó)
　        London        倫敦
Can        Canada        加拿大
　        Ottawa        渥太華
Ch        China        中國(guó)
　        Beijing        北京
Fra        France        法國(guó)
　        Paris        巴黎
Ger        Germany        德國(guó)
　        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(dá)
Ir        Irag        伊拉克
　        Baghdad        巴格達(dá)
Ir        Ireland        愛(ài)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(guó)
　        Washington        華盛頓
Mac        Macao        澳門(mén)
Mil        Milan        (意)米蘭
Tib        Tibet        西藏
TW        Taiwan        臺(tái)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?qǐng)A（￥）
Lit         Lira         里拉
M        Mark        馬克
MYR        Malaysian Ringgit        馬來(lái)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(guó)幣
TWD        Taiwan new Dollar        新臺(tái)幣
USD        U.S.dollar        美元（＄）
四、醫(yī)學(xué)藥學(xué)名詞
510(k)         Premarket Notification For Medical Devices Substantially Equivalent To Products Already On The Market         對(duì)實(shí)質(zhì)等效于已上市產(chǎn)品的醫(yī)療器械的上市前通知
AAD        Atherosclerotic Arterial Disease        動(dòng)脈粥樣硬化病
AADA         Abbreviated Antibiotic Drug
Application         簡(jiǎn)化抗生素藥品申請(qǐng)
AA-DS        Acute Arthritis-Dermatitis Syndrome        急性關(guān)節(jié)炎－皮炎綜合癥
AAE        Acute Allergic Encephalitis        急性過(guò)敏性腦炎
AAM        Acute Aseptic Meningitis         急性無(wú)菌性腦膜炎
AAR        Active Avoidance Reaction         主動(dòng)回避反應(yīng)
AARIT        Antigen-Antibody Reaction Inhibition
Test        抗原－抗體反應(yīng)抑制試驗(yàn)
AAT        Acute Abdominal Tympany        急性腹脹
ABE        Acute Bacterial Endocarditis        急性細(xì)菌性心內(nèi)膜炎
ABMR        Autologous Bone Marrow Rescue        自身骨髓解救
ABO        Blood Classification System         血液分類(lèi)系統(tǒng)
ABP         Antigen-Blinding Protein         抗原結(jié)合蛋白
ABS        Aging Brain Syndrome        老年腦綜合癥
ACAD        Asymptomatic Coronary Artery Disease         無(wú)癥狀性冠狀動(dòng)脈疾病
A-CAH        Autoimmune Chronic Active Hepatitis        自身免疫慢性活動(dòng)性肝炎
ACPP        Adrenocortical Polypeptide         腎上腺皮質(zhì)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(yīng)；藥品不良反應(yīng)
ADR         Adverse Drug Report         不良藥品報(bào)告；藥品不良反應(yīng)報(bào)告
AERS         Adverse Events Reporting System         不良事件報(bào)告系統(tǒng)
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(guó)衛(wèi)生信息庫(kù)
AIDS         Acquired Immune Deficiency Syndrome         獲得性免疫缺乏綜合癥；愛(ài)滋病
ANDA         Abbreviated New Drug Application         簡(jiǎn)化新藥申請(qǐng)
ASCT        Autologous Stem Cell Transplan-Tation        自體干細(xì)胞移植
ATP        Adenosine Triphosphate        三磷酸腺甘
BIMO         Bioresearch Monitoring         生物研究監(jiān)測(cè)
BLA         Biologic License Application         生物制品許可申請(qǐng)
BP        British Pharmacopoeia        《英國(guó)藥典》
BSE         Bovine spongiform encephalopathy
(mad cow disease)         牛海綿狀腦病(瘋牛病)
CGMPs         Current good manufacturing practices         現(xiàn)行良好制造規(guī)范；現(xiàn)行藥品生產(chǎn)質(zhì)量管理規(guī)范
CJD         Creutzfeldt-Jakob disease         克雅氏病
COS        Certificate of Suitability        (《歐洲藥典》)適用性證書(shū)
CP        The Pharmacopoeia of the PRC        《中國(guó)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(dòng)態(tài)流血
DCPC        Deacetyl cephalosporin C        脫乙酰頭孢菌素C
DD        Dangerous drug        危險(xiǎn)藥品
DDA        Dangerous Drugs Act        危險(xiǎn)藥品法
DDC        Dangerous drug cabinet        危險(xiǎn)藥品柜
DDD        Defined daily dose         規(guī)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(píng)價(jià)
DE        Dose equivalent         等價(jià)劑量；劑量當(dāng)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(fā)疾?。凰幵葱约膊?br /> 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(bǔ)充劑健康與教育法》
DUR        Drug utilization review        藥物利用評(píng)價(jià)
DUR        Drug use review        藥物使用評(píng)論
EFA        Essential fatty acid         必需脂肪酸
EHC        Essential hypercholesterolemia        原發(fā)性高膽固醇血癥
EIA        Enzyme immunoassay        酶免疫分析
ELA         Establishment license application         機(jī)構(gòu)許可申請(qǐng)
ELISA        Enzyme-linked immunosorbent assay        酶聯(lián)免疫吸附測(cè)定
EP        European pharmacopoeia        《歐洲藥典》
FD&C Act         Federal Food, Drug and Cosmetic Act         《聯(lián)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(xiàn)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(biāo)識(shí)法》
FSOT        Fused-silica open tubular column        熔融二氧化硅空心柱
FY         Fiscal year (October - September)         財(cái)政年度(10月—9月)
GAPs         Good agricultural practices         良好農(nóng)業(yè)規(guī)范；中藥材生產(chǎn)質(zhì)量管理規(guī)范
GATT         General Agreement on Tariffs and Trade         《關(guān)稅與貿(mào)易總協(xié)定》
GCP        Good clinical practice        良好臨床規(guī)范；藥品臨床研究質(zhì)量管理規(guī)范
GDP        Good dispensing practice        良好調(diào)配規(guī)范；
GF        Growth factor        生長(zhǎng)因子
GLP        Good laboratory practice        良好實(shí)驗(yàn)室規(guī)范；藥品非臨床研究質(zhì)量管理規(guī)范
GMP        Good manufacturing practices         藥品生產(chǎn)和管理規(guī)范
GPP        Good pharmacy practice        良好藥房規(guī)范；醫(yī)療機(jī)構(gòu)制劑配制管理規(guī)范
GPSP        Good Post-marketing Surveillance
Practice        良好上市后監(jiān)督規(guī)范；上市藥品監(jiān)督規(guī)范
GRAS         Generally Recognized as Safe food
ingredients         公認(rèn)安全的食品成分
GSP        Good supplying practice        良好供應(yīng)規(guī)范；藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范
HACCP         Hazard Analysis Critical Control Points (a quality assurance and inspection technique)         危害分析與關(guān)鍵控制點(diǎn)(一種質(zhì)量保證和檢查技術(shù))
HAR        Hemoagglutination reaction        血細(xì)胞凝集反應(yīng)
HARM        Heparin assay rapid method        肝素快速測(cè)定方法
HAs        Highest asymptomatic dose        最大無(wú)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(fā)性無(wú)菌性壞死
IBQ        Illness behavior questionnaire        病態(tài)行為調(diào)查表
IBV        Infectious bronchitis vaccine         感染性支氣管炎疫苗
ICF        Intensive care facility        重癥監(jiān)護(hù)設(shè)施
ICF        Intensive care facility        重癥監(jiān)護(hù)設(shè)施
Icx        Immune complex        免疫復(fù)合體
IIS        Intensive immunosuppression        加強(qiáng)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(guó)際非專(zhuān)有藥名
IRTU        Integrating regulatory transcription unit        整合調(diào)解轉(zhuǎn)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(shù)
IU        International unit        國(guó)際單位
Ksp        Solubility product        可溶性產(chǎn)物
LACF         Low acid canned foods         低酸罐裝食品
LAN         Local area network         局域網(wǎng)；局部區(qū)域網(wǎng)絡(luò)
LC50        Median lethal concentration        半數(shù)致死濃度
LD50        Median lethal dose        半數(shù)致死量
LFD        Least fatal dose         最低致死劑量
LIE        Liquid ion evaporation        液體離子蒸發(fā)
M&M        Morbidity and mortality        發(fā)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(yī)療咨詢服務(wù)
MB        Microbiological assay        微生物鑒定
MDG        Mean diastolic gradient        平均收縮梯度
MDR         Medical Device Reporting system         醫(yī)療器械報(bào)告系統(tǒng)
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(shù)質(zhì)量標(biāo)準(zhǔn)法》
MRA         Mutual recognition agreement         互認(rèn)協(xié)議
MRFIT        Multiple risk factor interviention trial         多種危險(xiǎn)因子干擾試驗(yàn)
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(shí)間
N.F.        National formulary        《(美國(guó))國(guó)家處方集》
NAFTA         North atlantic free trade agreement         《北大西洋自由貿(mào)易協(xié)議 》
NARMS         National antimicrobial resistance
monitoring system         國(guó)家耐抗菌素監(jiān)測(cè)系統(tǒng)
NCP        Noncollagen protein        非膠原蛋白
NDA         New drug application         新藥申請(qǐng)
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(jīng)生長(zhǎng)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(yíng)養(yǎng)性缺鐵性貧血
NIR        Nosocomial infection rate        醫(yī)院感染率
NK        Natural killer (cell)        自然殺傷細(xì)胞
NKDA        No known drug allergies         未知的藥物過(guò)敏癥
NKFA        No known food allergies         未知的食物過(guò)敏癥
NLEA         Nutrition Labeling and Education Act         《營(yíng)養(yǎng)標(biāo)識(shí)與教育法》
NME         New molecular entity         新分子實(shí)體
NMR        Neonatal mortality rate         新生兒死亡率
NNF        Nonnutritive fiber        無(wú)營(yíng)養(yǎng)纖維
NNS        Nonneoplastic syndrome        非腫瘤性綜合癥
NOED        Non-observed effect dose        無(wú)毒性效應(yīng)劑量
NOHL        Non-organic hearing loss        非器質(zhì)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(cè)定
OASIS         Operational and Administrative System for Import Support         進(jìn)口支持的運(yùn)作和管理系統(tǒng)
OTC         Over the counter drug (Nonprescription drugs)        放在柜臺(tái)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(yīng)
PDMS        Plasma desorption mass spectrometry        等離子體解吸質(zhì)譜法
PDUFA         Prescription Drug User Fee Act of 1992         《1992年處方藥用戶費(fèi)法》
PE        Pharmacoeconomica        藥物經(jīng)濟(jì)學(xué)
Ph Gal         Pharmacopoeia galisa        《法國(guó)藥典》[拉]
Ph J        Pharmacopoeia japonica         《日本藥典》
PHA        Phytohemagglutinin        植物凝集素
PhI        Pharmacopoeia internationalis        《國(guó)際藥典》[拉]
PL        Phospholipid        磷脂
PLA         Product license application         產(chǎn)品許可申請(qǐng)
PMA         Premarket Approval (Application to
market medical device that requires
premarket approval)         上市前批準(zhǔn)(要求上市前批準(zhǔn)的醫(yī)療器械的上市申請(qǐng))
PMS        Postmarking surveilance        上市后監(jiān)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(shí)間
QA        Quality assurance        質(zhì)量保證
QC        Quality control        質(zhì)量控制
QSAR        Quantitative structure activity
relationship        定量構(gòu)效關(guān)系
R&D        Research and development        研究與開(kāi)發(fā)
RA         Rheumatoid arthritis         類(lèi)風(fēng)濕性關(guān)節(jié)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(fù)制性
RIA        Radioimmunoassay        放射免疫測(cè)定
RNA        Ribonucleic acid        核糖核酸
SAB        Serum albumin        血清白蛋白
SARS        Severe acute respiratory syndrome        嚴(yán)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(mén)氏菌
SOP        Standard operating procedure        標(biāo)準(zhǔn)操作規(guī)程
TB         Tuberculosis         結(jié)核病
TD50        Median toxic dose        半數(shù)中毒量
TPN        Total parenteral nutrition        全腸外營(yíng)養(yǎng)
TQC        Total quality control        全面質(zhì)量控制
USP        The united states pharmacopoeia        《美國(guó)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(zhì)炎；小兒麻痹癥
PT        Pulmonary tuberculosis        肺結(jié)核
Rab        Rabies        狂犬病
SARS        Severe acute respiratory syndrome        嚴(yán)重急性呼吸道綜合癥
SF        Scarlet fever        猩紅熱
SY        Syphilis        梅毒
TB        Tuberculosis        結(jié)核病
Ty        Typhoid        傷寒
VH        Viral hepatitis        病毒性肝炎
Vl        Visceral leishmaniasis        黑熱病，又稱內(nèi)臟利什曼病
WC        Whooping cough        百日咳
　        Anthracnose        炭疽病
　        Shigellosis        細(xì)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(fēng)
六、化驗(yàn)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(shí)間
CHO         Cholesterol        膽固醇
CT        Clotting time        血塊形成時(shí)間
CT        Coagulation time        凝固時(shí)間
D-BIL         Direct bilirubin        直接膽紅素
er        Erythrocyte        紅細(xì)胞
GLU         Glucose        葡萄糖
GOT        Glutamic-oxal(o)acetic transaminase        谷草轉(zhuǎn)氨酶
GPT        Glutamic-pyruvic transaminase        谷丙轉(zhuǎn)氨酶
GT         Glutamyl transpeptidase        谷氨酰轉(zhuǎn)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(yàn)
PhoH        Phosphorus        磷
PL        Platelet        血小板
pr        Protein        蛋白質(zhì)
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(xì)胞
　        Erythrocyte sedimentation        血沉；紅細(xì)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(shù)
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(nèi)注射
　        External use        外用
八、法律術(shù)語(yǔ)
a        Action        訴訟
ARB        Arbitration        仲裁
c.l.        Civil law        民法
cl.        Clause        條款
IP        Import permit        進(jìn)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(guī)則，條例
Reg.No.        Registered number        注冊(cè)號(hào)，登記的號(hào)
repr        Representative        代理人，繼承人
resp        Respond        承擔(dān)責(zé)任
sup        Supplement        附加（補(bǔ)充）條款
Sup Ct        Supreme court        最高法院
　        Absolute discharge        無(wú)條件釋放
　        Acquire title to the objects        就標(biāo)的物取得權(quán)利
　        Act of tort        侵權(quán)行為
　        Administered prices        控制價(jià)格
　        Administrative penalty        行政處罰
　        Administrative regulations        行政法規(guī)
　        Alimony        贍養(yǎng)費(fèi)
　        Body corporate        法人團(tuán)體
　        Business aggrement        業(yè)務(wù)協(xié)定
　        Circuit of action        巡回訴訟
　        Civil action        民事訴訟
　        Civil legal relations        民事法律關(guān)系
　        Civil sanctions        民事制裁
　        Contraband of import        非法進(jìn)口
　        Contract of sales         銷(xiāo)售合同
　        Econmic dispute        經(jīng)濟(jì)糾紛
　        Franchise        經(jīng)銷(xiāo)權(quán)；特許權(quán)
　        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(zhǔn)書(shū)
　        Interested party        厲害關(guān)系人
　        Juristic person        法人
　        Labour protection        勞動(dòng)保護(hù)
　        Legal basis        法律根據(jù)
　        Legal provisions        法律規(guī)定
　        Legal relation         法律關(guān)系
　        Legal system        法制
　        Legislation on labour protection        勞動(dòng)保護(hù)法規(guī)
　        Legislature organ        立法機(jī)關(guān)
　        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(jià)格控制
　        Processing of investor's raw materials        來(lái)料加工
　        Prosecutor         起訴人
　        Remote damege        間接損害
　        Trade agreement        貿(mào)易協(xié)定
　        Without obligation        解除責(zé)任
九、WTO相關(guān)術(shù)語(yǔ)
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(chǎn)地證
C/D         Customs declaration        報(bào)關(guān)單
CFR        Cost and freight        成本加運(yùn)費(fèi)價(jià)
CIF         Cost,insurance&freight        成本、保險(xiǎn)加運(yùn)費(fèi)價(jià)
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(jià)；完稅后價(jià)值
DSB        Dispute settlement body        爭(zhēng)端解決機(jī)構(gòu)
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(jìn)口
L/C         Letter of credit        信用證
MFN        Most favored nation        最惠國(guó)待遇
OECD        Organization for Economic Cooperation and Development        經(jīng)濟(jì)合作與發(fā)展組織
P/L         Packing list        裝箱單、明細(xì)表
S/C        Sales contract        銷(xiāo)售確認(rèn)書(shū)
TBT        Technical Barrier to Trade        貿(mào)易技術(shù)壁壘
TRO        Tariff-rate Quota        關(guān)稅配額
URAA        Agreement on Agriculture        農(nóng)業(yè)協(xié)議
　        Article of General Agreement on Tariffs and Trade        關(guān)貿(mào)總協(xié)定條款
　        Agreement on Import Procedures        進(jìn)口許可程序協(xié)議
　        Agreement on Preshipment Inspection        裝運(yùn)前檢驗(yàn)協(xié)議
　        Agreement on Safeguards        保障措施協(xié)議
　        Agreement on Technical Barriers to
Trade        技術(shù)貿(mào)易壁壘協(xié)議
　        Blue box policies        藍(lán)箱政策
　        Bound tariff rates        約束稅率
　        Country schedules        國(guó)家減讓表
　        Market access        市場(chǎng)準(zhǔn)入
　        Non-tariff trade barriers        非關(guān)稅貿(mào)易壁壘
　        Notification process        通知程序
　        Special and differential treatment        特殊差別待遇
　        Tariff        關(guān)稅
　        Tariffication        關(guān)稅化


有機(jī)物英語(yǔ)單詞后綴表
-acetal  縮醇
acid  酸
-al  醛
alcohol  醇
-aldehyde  醛
-aldechydic acid  醛酸
-amarime（或-marine） 苦苷
-amic acid  酰胺酸
-amide  酰胺
-amide acid （=amic acid） 酰胺酸
-amidine  脒
-amidoxime  脒肟
-amidrazone  脒腙
-amine  胺
-ane  烷
anhydride -ic anhydride  
anil  縮苯胺
-anilic acid  酰苯胺酸
-anilide  酰苯胺
-aniside  酰茴香醛
-arsine  胂
-arsinic acid  [美國(guó)名指]次胂酸
-arsinous acid  [美國(guó)名和英國(guó)名均指]卑胂酸
-arsinoxide  胂氧
-arsonic acid  [美國(guó)名和英國(guó)名均指]胂酸
-arsonous acid  [美國(guó)名指]亞胂酸
-ase  酶
-azide  疊氮
-azine  連氮
-betaine  內(nèi)胺鹽
-biarsine  聯(lián)胂
bi...oyl di..oyl  
-bistibine  聯(lián)銻
bi...yl  聯(lián)...
-borane  硼烷
-borinic acid 二取代硼酸
-boronic acid  硼酸
-bromohydrin 溴醇
-cacodyl 卡可基
-cain(e) 卡因
-carbamic acid  氨甲酸
-carbazinic acid  肼甲酸
-carbinol  甲醇
-carbodithioic acid  二硫代羧酸
carbohydrazide  N-?；ò碗?br /> -carbohydraoxamamide  甲肟胺
-carbohydroxamic acid  羧肟胺
-carbonamidine  甲脒
-carbonitrile  甲腈
-barbonyl  羰基
-carbothioic acid  羧硫代酸
-carbothiolic acid  甲硫羥酸
-carbothionic acid  甲硫羰酸
-carboxaldehyde  甲醛
-carboxamide  甲酰胺
-carboxamidine 甲脒
-carboxamidoxime  甲胺肟
-carboximidic acid  甲亞胺酸
-carboxylic acid  羧酸
-carbylamine  胩
-cene  并...苯
-chloroarine  氯胂
-chlorohydrin  氯醇
-chrysine  柯因
-cyanamide  氨腈
-cyanhydrin  氰醇
-cyanoarsin  氰胂
-diarsine  聯(lián)胂
-diazonium  重氮
-dicarboximide  二甲酰亞胺
-dichloroarsine  二氯胂
-diimide  聯(lián)亞胺
-din(e)  定；啶
di...(o)yl  聯(lián)…酰
-disulfide  二硫
-dithiocarbamic acid  氨基二硫代羧酸
-di...ylene  聯(lián)二…亞基
-drin(e)  君[俗名詞尾]
-e-  裂[嵌在末一音節(jié)之前，指分裂后之產(chǎn)物]
-ene  烯
-ester  酯
ose  糖
-oside 糖苷
-oxide  氧化物
-oxime  肟
-oyl  酰
-oyl halide  酰鹵
-ozonide  臭氧
-peroxide  過(guò)氧
-phene 芬
-phine  粉；芬        -etane  丁環(huán)
-ete  丁
-etene  丁亭[4元無(wú)氮一烯環(huán)，中文中與-etine不分]
-ether  醚
-etidine  丁啶
-etine  丁亭[4元含氮飽和環(huán)]
-florine  花精
-follin  葉素
-folin  葉素
-form  仿
gen  精
-genin  配基
-germanonic acid  基鍺酸
-gin  精
-glycol  二醇
-hemiacetal  縮一醇
-hydrazidc  酰肼
-hydrazidine  肼定
-hydrazine  肼
-hydrazone  腙
-hydrin  醇
hydrogen ester  氫酯
hydrosulfamine  巰胺
-hydroxamamide  肟胺
-hydroxamic acid  羥肟酸
-hydroxylamine  胲
-ic anhydride  酸酐
-ic semialdehyde  醛酸
-ide  酰胺
-il 偶酰
-imide  酰亞胺
-imidic acid  亞胺酸
-imine  亞胺
-in  精
-inium -onium
-iodohydrin  碘醇
-irane 丙烷
-irene 丙烯
-iridine  丙啶
-irine  丙因
-isothiourca  異硫脲
-isource  異脲
-ite  糖醇
-itol 糖醇
-ium -onium
-ketal  酮縮醇
-ketene  乙烯酮
-ketazine  酮連氮
-ketimide  酮亞胺
-ketol  乙酮醇
-ketone  酮
-ketoxime  甲酮肟
-lactam  內(nèi)酰胺
-lactim  內(nèi)酰亞胺
-lactone  內(nèi)酯
-lin  靈
-lin(e)  靈
-lysin   溶素
-mercaptal  醛縮硫醇
-mercaptan  硫醇
-mereaptole  酮縮硫醇
-methine  甲堿
-methylene  亞甲基
-min  明
-morpholide  N-?；鶈徇?br /> -naphthalide N-酰基萘胺
-naphthone  酰萘
-nin(e)  寧
-nitramine  硝胺
-nitrile  腈
-nitrolic acid  硝肟酸
-nitrosamine  亞硝胺
-nitrosate  硝酯肟酸
-nitrosolic acid  亞硝肟酸
-nitrosite  亞硝酯肟酸
-oic acid  酸
-oin  偶姻
-ol  醇
-ole  腦，醚
-olic acid  醇酸；腦酸；油酸；炔酸
-olid(e)  交酯
-olidine  烷[5元含氮飽和雜環(huán)]
-oline  啉[5元一烯雜環(huán)]
-onane  壬環(huán)[9元飽和雜環(huán)]
-one  酮
-ionic acid 酮酸
-ionic acid 糖酸
-onium  钅翁
-o... one  ...酰...酮
-or  腦
-orthosiliconic acid  原硅酸
-osan  聚糖
-osazone  脎-        saccharic acid  糖質(zhì)酸
saccharinic acid  糖精酸
-sapegenin  皂萆配基
-saponine  皂萆苷
-selenenic acid  次硒酸
-seleninic acid  亞硒酸
-selenol  硒醇
-selenonic acid  硒酸
-semiacetal  醛縮一醇
semialdehyde  -ic semialdehyde
-semicarbazone  縮氨脲
-semicarbazide  氨脲
-semioxamazone  縮半萆肼
-siliconic acid  硅酸
-sin  僧；素
-st-  甾
-stannonic acid  錫酸
-stibine  月弟
-stibinic acid  次銻酸
-stibinous acid  卑銻酸
stibonic acid  銻酸
-stibonium  銻
-stibonous acid  亞銻酸
sulfenamide  次磺酰胺
-sulfenic acid  次磺酸
-sulfide  硫
-sulfilimine  硫亞胺
-sulfinamide  亞磺酰胺
-sulfinic acid  亞磺酸
-sulfonamide  磺酰胺
-sulfone  砜
-sulfonic acid  磺酸
-sulfoxide  亞砜
-sultam  磺內(nèi)酰胺
-sultone  磺內(nèi)酯
-tanin  單寧
-tannin 單寧
-tellurinic acid  亞碲酸
-telluronic acid  碲酸
-thetin(e)  噻亭
-thin  質(zhì)
thioacetal  醛縮硫醇
-thiocarbazone   硫卡巴腙
-pin(e)  品
-pinacol  頻哪醇
-pinacolin(e)  頻哪酮
-pinacolone  頻哪酮
-pinacone -pinacol
-piperidine  N-?；哙?br /> -plumbonic acid  鉛酸
-quine  奎
-rin  扔，苷
-rufin  絳酚
-thiohydroxylamine  硫胲
-thioic acid 硫代酸
-thioketene  乙烯硫酮
-thiol  硫醇
-thiolactone  硫代內(nèi)酯
-thiosemicarbazone  縮胺基硫脲
-thiolic acid  硫羥酸
-thione  硫酮
-thionic acid  硫羰酸
-thionothiolic acid  二硫代羧酸
-thiourea  硫脲
-tin  亭
-toluide  N-?；妆桨?br /> -toxin(e) 毒
-trin  醇
-trisulfide  三硫
-tropin  托品
-ulose  酮糖
-area  脲
-urethan(e)  尿烷
-urethylan(e)  尿基烷
-uric acid  尿酸
-uronic acid  糖醛酸，糖酮酸
-xanthin  黃質(zhì)
-xanthogenic acid  黃元酸
-xylide  N-酰二甲苯胺
-yl 基
-ylene  亞基
-yl halide  鹵代物
-ylidene  亞基
-ylidyne  次基
-ylium  钅翁
-yne  炔
-phenetidide  ?；揭叶?br /> -phenone  酰苯
-phosphine  膦
-phosphinic acid  次磷酸
-phosphinous acid  卑磷酸
-phosphonic acid  磷酸
-phosphonous acid  亞磷酸
-phyllin(e)  非靈；植素
-picrin  苦堿

lzren

很好的畜牧獸醫(yī)英語(yǔ)資料

bjliyi

有用