常用藥品監(jiān)管英語與縮略語

1、政策信息常用藥品監(jiān)管英語與縮略語監(jiān)管英語1.中華人民共和國藥品管理法 ( Control Law of the People's Republic of China)2.藥品生產企業(yè)管理 ( control over drug manufacturers)3.藥品經營企業(yè)管理( control over drug distributors )4.醫(yī)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 packagin

2、g)7.藥品價格和廣告的管理 (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(yè)(drug manufacturers)15.經營企業(yè)(drug distributors)16.醫(yī)療機構(

3、medical institutions)17.藥品監(jiān)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(guī)范(Good Manufacturing Practice for Pharmaceutical Products (GMP)22.藥品經營質量管理規(guī)范(Good Supply Practice for Pharmaceutical Products (GSP)23

4、.藥品生產許可證(Drug Manufacturing Certificate)24.藥品經營許可證(Drug Supply Certificate)25.醫(yī)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(jiān)督管理

5、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(jiān)督管理部門主管全國藥品監(jiān)督管理工作。(The drug

6、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)督管理部門負責本行政區(qū)域內的藥品監(jiān)督管理工作。 (The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shal

7、l be responsible for drug regulation in their administrative areas. )33.藥品監(jiān)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(jiān)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 re

8、view and approval and controlling drug quality pursuant to the law.)34.開辦藥品生產企業(yè)，須經企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)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, auto

9、nomous 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(fā)證。 (The term of validation an

10、d 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)督管理部門批準開辦藥品生產企業(yè)，應當符合國家制定的藥品行業(yè)發(fā)展規(guī)劃和產業(yè)政策，防止重復建設。 (When giving approval to the newly-established manufacturer, the drug regula

11、tory 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(yè)，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(wèi)生環(huán)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

12、的儀器設備；（四）具有保證藥品質量的規(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 d

13、rug 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(yè)必須按照國務院藥品監(jiān)督管理部門依據(jù)本法制

14、定的藥品生產質量管理規(guī)范組織生產。藥品監(jiān)督管理部門按照規(guī)定對藥品生產企業(yè)是否符合藥品生產質量管理規(guī)范的要求進行認證；對認證合格的，發(fā)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

15、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(jiān)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 produce

16、d 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(yè)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 p

17、rocess 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.)

18、42.藥品生產企業(yè)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(qū)、直轄市人民政府藥品監(jiān)督管理部門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 C

19、hinese 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(jiān)督管理部門或者國務院藥品監(jiān)督管理部門授權的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準，藥品生產企業(yè)可以接受委托生產藥品。 (A drug manufacturer may not accept any cont

20、ract 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.

21、)45.開辦藥品批發(fā)企業(yè)，須經企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)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

22、.開辦藥品零售企業(yè)，須經企業(yè)所在地縣級以上地方藥品監(jiān)督管理部門批準并發(fā)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(fā)、零售企業(yè)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

23、 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(fā)證。 (The valid period and the scope of business shall be indicated in the Drug Supply Ce

24、rtificate. For renewal of the certificate upon expiration, reviewing and approval again is required.)49.開辦藥品經營企業(yè)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(yè)場所、設備、倉儲設施、衛(wèi)生環(huán)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(guī)章制度。 (A drug distributor to be established shall meet the following requirements:(

25、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 r

26、ules and regulations to govern the quality of the drugs to be distributed.)50.藥品經營企業(yè)必須按照國務院藥品監(jiān)督管理部門依據(jù)本法制定的藥品經營質量管理規(guī)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 t

27、his Law.)51.藥品監(jiān)督管理部門按照規(guī)定對藥品經營企業(yè)是否符合藥品經營質量管理規(guī)范的要求進行認證；對認證合格的，發(fā)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(yè)購進藥品，必須建立并執(zhí)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(guī)定要求的，不得購進。 (Af

28、ter 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(yè)購銷藥品，必須有真實完整的購銷記錄。(Drug distributo

29、rs 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(guī)格、批號、有效期、生產廠商、購（銷）貨單位、購（銷）貨數(shù)量、購銷價格、購（銷）貨日期及國務院藥品監(jiān)督管理部門規(guī)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, purc

30、haser (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(yè)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.

31、藥品經營企業(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、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(zhí)行檢查制度。

32、 (An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse.)58.城鄉(xiāng)集市貿易市場可以出售中藥材，國務院另有規(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

33、售企業(yè)在規(guī)定的范圍內可以在城鄉(xiāng)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(yī)療機構配制制劑，須經所在地省、自

34、治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準，發(fā)給醫(yī)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

35、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(yī)療機構制劑許可證的醫(yī)療機構，不得配制制劑。 (No medical institution is permitted to dispense pharmaceutical preparations

36、 without the Pharmaceutical Preparation Certificate for Medical Institution.)62.醫(yī)療機構制劑許可證應當標明有效期，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 req

37、uired.)63.醫(yī)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(qū)、直轄市人民政府藥品監(jiān)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 loc

38、al drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government.)64.醫(yī)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(jiān)督管理部門的規(guī)定如實報送研制方法、質量指標、藥理及毒理試驗結

39、果等有關資料和樣品，經國務院藥品監(jiān)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

40、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(jiān)督管理部門批準，發(fā)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 r

41、egulatory 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(zhí)行藥物非臨床研究質量管理規(guī)范、藥物臨床試驗質量管理規(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 Go

42、od 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(jiān)督管理部門批準，并發(fā)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 numbe

43、r 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(jiān)督管理部門會同國務院中醫(yī)藥管理部門制定。(The list of the Chinese crude drugs and the prepared slices of the Chinese

44、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(yè)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

45、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(jiān)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 Counci

46、l shall serve as the National Drug Standards.)73.國務院藥品監(jiān)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(jiān)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。 (

47、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(yè)、藥品經營企業(yè)、醫(yī)療機構必須從具有藥品生產、經營資格的企業(yè)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 medic

48、al 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(yī)療用毒性藥品、放射性藥品，實行特殊管理。(The State exercises special control over

49、 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 n

50、on-prescription drugs. )79.藥品進口，須經國務院藥品監(jiān)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(fā)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 confor

51、ms 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(fā)生重大災情、疫情及其他突發(fā)事件時，國務院規(guī)定的部門可以緊急調用企業(yè)藥品。 (When major disasters, epidemic situations or other emergencies occur in

52、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

53、deemed as a counterfeit drug:（一）藥品所含成份與國家藥品標準規(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

54、 falling into the following categories shall be deemed as a counterfeit drug:)（一）國務院藥品監(jiān)督管理部門規(guī)定禁止使用的； (Its 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 witho

55、ut 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(guī)定范圍的。 (The indications or functions in

56、dicated 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

57、 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

58、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(guī)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(yè)、藥品經營企業(yè)和醫(yī)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