药品注册英文
Glossary（术语）：
Regulatory Affairs （RA）：药政事务
drug authority：药政当局
investigation and research before project approval：立项前的调研
Market Authorization （ MA ）：上市许可
post-approval commitment study：上市后的承诺研究
post-approval variation application：补充申请
life cycle ：生命周期
Chemistry, Manufacturing, and Controls （ CMC）：药品的化学、生产
和控制
cross-functional teams：公司内部各部门
look at the big picture：从大局考虑
think strategically：进行战略性思考
risks and benefits：风险和获益
Food and Drug Administration （FDA）：美国食品药品监督管理局
European Medicines Agency （EMA ）：欧洲药品管理局International Multi-center Clinical Trial （IMCT ）：国际多中心临床试
验
Bioequivalence study （ BE study）：生物等效性试验
generic drug：仿制药
Center for Drug Evaluation （CDE）：SFDA 下属的药品审评中心
Quality by Design （QbD）：质量源于设计
CMC Pilot Program：FDA 在业内开展的关于QbD 的试点研究
early launch：早日上市
design space：设计空间
Business Development （BD）：业务发展部门
Imported Drug License （IDL ）：进口药品注册证
Manufacturing License （ ML ）：生产许可证
Clinical Trial Permission （CTP）：临床试验批件
Active Pharmaceutical Ingredient （API ）：原料药
Orange Book：橙皮书
business value：商业价值
the Pharmacopoeia of the People's Republic of China（ChP）：中国药典the United States Pharmacopoeia（USP）：美国药典
the European Pharmacopoeia（Ph. Eur.或 EP）：欧洲药典
List of Essential Drugs （EDL ）：基本药物目录
Reimbursement Drug List （RDL）：医保目录）
typing error：打印错误
slip of the pen：笔误
Drug Master File （DMF ）：药物主文件
Certificate of Analysis （CoA ）：检验报告
Marketing （MKT ）：市场部
market share：市场占有率
sales volume：销量
investigator brochure （IB ）：研究者手册
protocol：临床试验方案
priority ：优先度
package insert （PI）：说明书
labeling：包装标签
Patient Information Leaflet （PIL ）：患者使用的说明书
Summary of Product Characteristics （SmPC，SPC）：产品特性摘要
foil ：铝箔
carton：装药品的小盒
shipping label：运输包装标签
Medical：医学部
provincial drug administration （PDA）：省级药监局，包括省、自治
区和直辖市药品监督管理部门
Institute for Food and Drug Control：药检所
National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）：中国药品生物制品检定所，简称“中检所”
supplementary dossier：补充资料
approval letter：注册批件
out of specification （OOS）：超出标准、不合格
adverse effect （AE）：不良事件
trial waiver ：减免临床试验
Clinical ：临床部门
Commercial：商业部门
new chemical entity （NCE）：新化学实体
key opinion leader （KOL ）：关键意见领袖
off-label use：标签外使用
patient pool：患者库
deadline：最后期限
global trial ：全球性的临床试验，即国际多中心临床试验
regional trial：区域性的临床试验
TPD 加拿大卫生部治疗产品局adverse drug reaction, ADR 药物不良反应pharmacokinetics (PK ) 药物代谢动力学
他们继
续往前走。
走到了沃野，他们决定停下。
被打巴掌的那位差点淹死，幸好被朋友救过来了。
被救起后，他拿了一把小剑在石头上刻了：“今天我的好朋友救了我一命。
”
一旁好奇的朋友问到：
“为什么我打了你以后你要写在沙子上，而现在要刻在石头上呢？”
另一个笑笑回答说：“当被一个朋友伤害时，要写在易忘的地方，风会负责抹去它；
相反的如果被帮助，我们要把它刻在心灵的深处，任何风都抹不去的。
”
朋友之间相处，伤害往往是无心的，帮助却是真心的。
在日常生活中，就算最要好的朋友也会有摩擦，也会因为这些摩擦产生误会，以至于成为陌路。
友情的深浅，不仅在于朋友对你的才能钦佩到什么程度，更在于他对你的弱点容忍到什么程度。
学会将伤害丢在风里，将感动铭记心底，才可以让我们的友谊历久弥新！
友谊是我们哀伤时的缓和剂，激情时的舒解剂；
是我们压力时的流泻口，是我们灾难时的庇护所；
是我们犹豫时的商议者，是我们脑子的清新剂。
但最重要的一点是，我们大家都要牢记的：
“切不可苛求朋友给你同样的回报，宽容一点，对自己也是对朋友。
”
爱因斯坦说：“世间最美好的东西，莫过于有几个头脑和心地都很正直的朋友。
”
他们继续往前走。
走到了沃野，他们决定停下。
被打巴掌的那位差点淹死，幸好被朋友救过来了。
被救起后，他拿了一把小剑在石头上刻了：“今天我的好朋友救了我一命。
”
一旁好奇的朋友问到：
“为什么我打了你以后你要写在沙子上，而现在要刻在石头上呢？”
另一个笑笑回答说：“当被一个朋友伤害时，要写在易忘的地方，风会负责抹去它；
相反的如果被帮助，我们要把它刻在心灵的深处，任何风都抹不去的。
”
朋友之间相处，伤害往往是无心的，帮助却是真心的。
在日常生活中，就算最要好的朋友也会有摩擦，也会因为这些摩擦产生误会，以至于成为陌路。
友情的深浅，不仅在于朋友对你的才能钦佩到什么程度，更在于他对你的弱点容忍到什么程度。
学会将伤害丢在风里，将感动铭记心底，才可以让我们的友谊历久弥新！
友谊是我们哀伤时的缓和剂，激情时的舒解剂；
是我们压力时的流泻口，是我们灾难时的庇护所；
是我们犹豫时的商议者，是我们脑子的清新剂。
但最重要的一点是，我们大家都要牢记的：
“切不可苛求朋友给你同样的回报，宽容一点，对自己也是对朋友。
”
爱因斯坦说：“世间最美好的东西，莫过于有几个头脑和心地都很正直的朋友。
”。
制药行业术语和英文简称
制药行业术语和英文简称名词解释NDA : New Drug Application /新药生产上市申请INDA : Investigational New Drug Application/药品临床试验申报ANDA: Abbreviated New Drug Application/仿制药及改剂型申请提出申请快速通道资格认定（Request for Fast Track Designation)Accelerated Approval（加速审批）: These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.Breakthrough Therapy Designations（突破性疗法资格认定）: A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.Fast Track Designation（快速通道资格认定）: Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.Priority Review（优先审核）: A Priority Review designation means FDA’s goal is to take action on an application within 6 months.Orphan Drug Act（罕见疾病药物法案）:也叫孤儿药注册1类和2类新药要进行新药临床试验申请（INDA）；3类和4类要做验证性临床。
注册用英文缩写
T/T
Telegraphic Transfer
电汇
L/C
Letter of Credit
PK
Pharmacokinetics
PD
pharmacodynamic
信用证
药代动力学 药效动力学
解释
CFR价=FOB价+运费 CIF价=FOB价+运费+保险 CIF价=CFR价/[1-(1+投保加成)×保险费率]
缩写全称中文名解释分类cdecenterdrugevaluation机构cfdachinafooddrugadministration国家食品药品监督管理总局机构mohministryhealth卫生部机构cfrcostfreight成本加运费外贸cifcostinsurancefreight外贸fobfreeboard离岸价外贸moqminimumorderquantity最低订货数量外贸bioequivalence生物等效性注册coacertificateanalysis品质分析证书注册cppcertificatepharmaceuticalproduct药品证书注册ctpclinicaltrialpermission药物临床试验批件注册dmfdrugmasterfile药品主文件注册gcpgoodclinicalpractice药物临床试验管理规范注册gmpgoodmanufacturingpractice药品生产质量管理规范注册gspgoodsupplypractice药品经营质量管理规范注册idlimporteddruglicense进口药品注册证注册pics国际药品认证合作组织注册国家食品药品监督管理总局药品评审中心cfr价fob价运费成本加保险费加运费到岸cif价fob价运费保险cif价cfr价11投保加成保险费率是指一种药物的不同制剂在相同实验条件下给予相同的剂量其吸收速度与程度没有明显差别
药品注册英文
药品注册英文公司标准化编码 [QQX96QT-XQQB89Q8-NQQJ6Q8-MQM9N]Glossary（术语）：Regulatory Affairs （RA）：药政事务drug authority：药政当局investigation and research before project approval：立项前的调研Market Authorization （MA）：上市许可post-approval commitment study：上市后的承诺研究post-approval variation application：补充申请life cycle：生命周期Chemistry, Manufacturing, and Controls （CMC）：药品的化学、生产和控制cross-functional teams：公司内部各部门look at the big picture：从大局考虑think strategically：进行战略性思考risks and benefits：风险和获益Food and Drug Administration （FDA）：美国食品药品监督管理局European Medicines Agency （EMA）：欧洲药品管理局International Multi-center Clinical Trial （IMCT）：国际多中心临床试验Bioequivalence study （BE study）：生物等效性试验generic drug：仿制药Center for Drug Evaluation （CDE）：SFDA下属的药品审评中心Quality by Design （QbD）：质量源于设计CMC Pilot Program：FDA在业内开展的关于QbD的试点研究early launch：早日上市design space：设计空间Business Development （BD）：业务发展部门Imported Drug License （IDL）：进口药品注册证Manufacturing License （ML）：生产许可证Clinical Trial Permission （CTP）：临床试验批件Active Pharmaceutical Ingredient （API）：原料药Orange Book：橙皮书business value：商业价值the Pharmacopoeia of the People's Republic of China （ChP）：中国药典the United States Pharmacopoeia （USP）：美国药典the European Pharmacopoeia （Ph. Eur.或EP）：欧洲药典List of Essential Drugs （EDL）：基本药物目录Reimbursement Drug List （RDL）：医保目录）typing error：打印错误slip of the pen：笔误Drug Master File （DMF）：药物主文件Certificate of Analysis （CoA）：检验报告Marketing （MKT）：市场部market share：市场占有率sales volume：销量investigator brochure （IB）：研究者手册protocol：临床试验方案priority：优先度package insert （PI）：说明书labeling：包装标签Patient Information Leaflet （PIL）：患者使用的说明书Summary of Product Characteristics （SmPC，SPC）：产品特性摘要foil：铝箔carton：装药品的小盒shipping label：运输包装标签Medical：医学部provincial drug administration （PDA）：省级药监局，包括省、自治区和直辖市药品监督管理部门Institute for Food and Drug Control：药检所National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）：中国药品生物制品检定所，简称“中检所”supplementary dossier：补充资料approval letter：注册批件out of specification （OOS）：超出标准、不合格adverse effect （AE）：不良事件trial waiver：减免临床试验Clinical：临床部门Commercial：商业部门new chemical entity （NCE）：新化学实体key opinion leader （KOL）：关键意见领袖off-label use：标签外使用patient pool：患者库deadline：最后期限global trial：全球性的临床试验，即国际多中心临床试验regional trial：区域性的临床试验TPD 加拿大卫生部治疗产品局adverse drug reaction, ADR 药物不良反应pharmacokinetics (PK ) 药物代谢动力学。
原料药国际注册
Issue Date Issue Date 24/10/2012 21/02/2006 17/03/2015 23/01/2008
Status Status VALID WITHDRAWN BY HOLDER VALID WITHDate
Type Type Chemistry
基于保密原则，无任何信息公布 年度数量统计 /Drugs/DevelopmentApprovalProcess/H owDrugsareDevelopedandApproved/DrugandBiologicAppro valReports/INDActivityReports/default.htm
/scripts/inspsearch/
ORA：Office of Regulatory Affairs
483报告：仅部分可见 /AboutFDA/CentersOffice s/OfficeofGlobalRegulatoryOperationsandPol icy/ORA/ORAElectronicReadingRoom/default .htm
US 药品注册——New Drug Application (NDA)
Approval Letter NDA涉及场地的现场审查
GMP/cGMP
NAI No Action Indicated VAI Voluntary Action Indicated OAI Official Action Indicated /scripts/inspsearch/ 483： /AboutFDA /CentersOffices/OfficeofGlobal RegulatoryOperationsandPolicy /ORA/ORAElectronicReadingRo om/default.htm
药品注册管理办法-英文版
DRUG REGISTRATION REGULATION(SFDA Order 28)(Translation by RDPAC, for Member use only)Drug Registration Regulation was approved on June 18, 2007 by SFDA executive meeting and is hereby published, which become effective from October 1, 2007.SFDA CommissionerShao MinliJuly 10, 2007 DRUG REGISTRATION REGULATIONChapter 1: General PrinciplesArticle 1:This Regulation is promulgated according to the Drug Administration Law of T he People’s Republic of China (Drug Administration Law), Administrative Licensing Law of T he People’s Republic of China(Administrative Licensing Law), and the Implementing Regulation of the Drug Administration Law of T he People’s Republic of China (Implementing Regulation) to ensure the safety, efficacy and quality control of drugs and standardize drug registration. Article 2:This Regulation shall apply to all drug research and clinical studies, application for clinical study, drug production and / or importation, as well as the drug approval review, registration inspection and drug administration in The People’s Republic of China (PRC).Article 3:Drug registration means the legal process by which a decision is made by SFDA, upon application of registration applicant, to either approve or not approve the conducting of a drug clinical trial, production or importation of a drug to be marketed, based on a systematic evaluation of the safety, efficacy and quality control of the drug.Article 4:The State shall encourage research and development of new drugs and exercise the approval via a special process of innovative new drugs, those for difficult to treat and life threatening diseases.Article 5:The State Food and Drug Administration (SFDA) is thecompetent national authority for drug registration, responsible for the review and approval of clinical studies, production and importation of drugs.Article 6:Drug registration should follow the principles of openness equality, fairness, and for the convenience of the publics.During drug registration, SFDA shall apply the systems of joint responsibility of the presiding reviewer, public disclosure and rescuing of the related staff, responsibility investigation for any wrongdoing, in order to administer the steps from acceptance, inspection, review, approval, through delivery, and subject to monitoring by the publics.Article 7:During drug registration, should the drug administrative authority consider any permitting issues of significant interest to the publics, the issues should be announced to the publics and public hearing should be held.Should the administrative permitting be related to any significant interest between applicant and other parties, before any decision is made, drug administration authorities should notify applicant and other parties of their entitlement to requesting hearings, statement and defending.Article 8:Drug administration authorities shall provide applicant with accessible information regarding drug registration acceptance, inspection, test, evaluation, approval progress and conclusion and so on.Drug administration authorities should publicly disclose the following information at the official website and / or office location.1.Drug registration application items, procedure, fee standards andbasis, timeline, table of content of all required dossier, as well as reference application documents. list and the related information of the staff at each steps fromacceptance, inspection, test, review, through approval.3.general information of drug registration such as formulary of theapproved drugs.Article 9:The drug administration authority, units and staffs involved shall assume the responsibility of protecting the technical secrets and data provided by applicants during the process of drug registration.Chapter 2: Basic RequirementsArticle 10: A drug registration applicant (applicant) means an institution that makes drug application and assumes corresponding liability for drugregistration.A local applicant shall be a legally registered institution in China and be competent to independently assume legal liability. A foreign applicant shall be a legally established pharmaceutical company outside of China. In making application for an imported drug registration, the foreign applicant shall use its office in China, or authorize an agent in China to handle the application.The person(s) handling the drug registration application shall have technical expertise, and be familiar with drug administration laws, regulations and technical requirements.Article 11:Drug registration application includes application for new drug, generic drug applications, application for imported drug, supplemental application, as well as re-registration application.A local applicant shall make application according to new drug or generic drug applications; a foreign applicant shall make application according to imported drug.Article 12: A new drug application means a registration application for a drug that has not been marketed in China.Applications made for a change in dosage form, or route of administration, additional new indication of drugs shall be made according to new drug registration procedure.Generic drug application means application for registration of a drug for which SFDA has already issued formal standards, however, application of biological products shall be follow new drug application.Application for imported drug means application for a drug produced outside China to be marketed in China.Supplemental application means an application for the change, addition, or cancellation of any item or contents in the existing registration approval of a new drug, generic drug applications, or imported drug.A re-registration application means the application to continue the drug production or importation after the expiry of the certified drug approval documents.Article 13:Applicants should provide sufficient and reliable research data to evidence the safety, effectiveness and quality control of the drugs, and assume liability of the truthfulness of the entire dossier.Article 14:In citing literature and materials, the name of the work(s) and journal(s) as well as volume, issue and page number shall be provided in theapplication dossier submitted for drug registration. For unpublished literature and materials, an authorization letter from the owner must be provided. For any foreign language materials a Chinese translation should be provided in accordance with relevant requirements.Article 15:SFDA shall implement the National pharmaceutical industry development plan and policy, and may organize an assessment of the benefit of introduction of drugs to the market.Article 16:During drug registration, drug administration authorities should conduct on site inspection and inspection chosen from decision of the pre-clinical study and clinical trials, as well as conduct on site inspection of production site prior to any marketing approval, in order to confirm the truthfulness, accuracy and completeness of the application dossier.Article 17:If two or more institutions jointly apply for drug registration, the application shall be made to the PDA where the drug manufacturer is located. If all the applicants are manufacturers, the application shall be made to the PDA where the drug manufacturer of the preparation is located. If none of the applicants is a drug manufacturer, the application shall be made to the PDA where the drug sample is pilot manufactured.Article 18:Regarding the drug or its formula, production process, indication etc., the applicant shall submit documents explaining the China patent status and ownership rights. If other party holds patent in China, the applicant shall submit a letter stating that the drug will not infringe on the patent rights of others. Upon acceptance of the application, drug administration authorities should publicly disclose the statement submitted by applicant.If an infringement dispute occurs during registration application, the parties shall resolve the matter according to relevant laws for patent administration. Article 19:For a drug that has obtained patent protection in China, another applicant may apply for registration within two years prior to the patent expiration. SFDA shall review the application according to this Regulation and, after expiration of the patent, issue a drug approval number, Imported Drug License or Drug Product License, for an application that meets requirements.Article 20: According to Article 35 of Implementation Regulation, for a period of 6 years from the date of the original applicant's approval, SFDA shall not approve a subsequent application that used, without the express consent of the original applicant, the undisclosed R&D data and other data generated by the original applicant for submission of application ofmanufacturing or marketing of a drug containing new chemical ingredients, unless the submitted data is generated by the subsequent applicant itself. Article 21:The scope of pre-clinical laboratory study (pre-clinical study) of a drug for registration includes synthetic process, extraction methods, physical-chemical properties and purity, dosage form selection, screening of formulas, preparation process, inspection methods, quality specification, stability, pharmacology, toxicology and pharmacokinetic study. For TCM preparations, information such as the source and the processing of raw materials should also be included. For biological products, information such as source, quality standards, storage condition, biological identity, genetic stability and immunology study of strain, cell strain as well as biological tissue should also be included.Article 22:Pre-clinical study of a drug shall be conducted in accordance with relevant regulations, where the drug safety evaluation must be conducted in accordance with Good Laboratory Practice for Pre-Clinical Laboratory Studies (GLP).Article 23:Institutions engaged in drug research and development shall have the necessary personnel, facility, equipment, instruments, conditions and management system needed corresponding to the research project, and shall guarantee the authenticity of all data and materials. The animals, reagents and raw materials used for experiments shall comply with relevant national regulations and requirements.Article 24:If an applicant authorizes another institution to conduct the study of drugs, or any single experiment, inspection or pilot production and manufacture, the applicant shall sign a contract with the authorized party, and make notes in the application dossier. The applicant is responsible for the truthfulness of the drug study data used in the application dossier. . Article 25:When an application is only made for registration of preparation, the raw materials of the investigative drug substance used for this preparation must have a Drug Approval Number, Imported Drug Certificate or Pharmaceutical Product Certificate, and must have been obtained from legal channels. Any investigative drug substance which does not have a Drug Approval Number, Imported drug Certificate or Pharmaceutical Product Certificate must be approved by SFDA.Article 26:If an applicant uses the drug study data from a foreign drug research for a drug registration application, an explanation for the study items, and referencing the page numbers issued by this institution shall be provided, and notarized certificate of the institution's legal overseas registration shall be attached. Only after the documents are authenticatedby SFDA may they be included in the registration documents. SFDA may send people to conduct on-site inspections, if necessary.Article 27: During the verification of drug studies, drug authorities may request the applicant or the drug research institute that conducted the experiments to repeat an experiment for any items by using the methods and data listed in the application dossier. SFDA may also designate other drug control institutes or drug research institutions to repeat the experiments or to validate the methodology.Article 28:Drug study shall be conducted in accordance with relevant technical guidelines issued by SFDA. If the applicant conducts the experiments according to other methods and techniques, the applicant shall provide information to evidence that the methods and techniques are scientific.Article 29:After obtaining the drug approval number, the applicant should produce the drug according to the process approved by SFDA. Drug administrations shall monitor the production according to the approved production process and standards.Chapter 3: Clinical Trials of DrugsArticle 30:Clinical study of drugs, including bioequivalence trials, must be approved by SFDA, and must be conducted in accordance with Good Clinical Practice (GCP).Drug administrations shall monitor the approved clinical studies.Article 31:Clinical trials should be conducted for the registration of a new drug. For registration application of generic drugs and supplemental application, clinical trails should be conducted in accordance with provisions specified in Appendix of this Regulation.Clinical trials are divided into Phase I, Phase II, Phase III and Phase IV. Phase I: Basic clinical pharmacology and human safety evaluation studies. To observe tolerance in human bodies and pharmacokinetics, providing a basis for a drug administration program.Phase II: A preliminary exploration on the therapeutic efficacy. The purpose is to evaluate the safety and efficacy of a new drug on patients within the target indication of the drugs, and providing the basis to devise Phase III Clinical Trial and to determine a drug administration program. Phase II Clinical Trial may be conducted in many ways includingrandomized blind controlled clinical trial in accordance with the purpose of the study.Phase III: The phase to confirm the therapeutic efficacy. The purpose is to further verify the safety and efficacy of a new drug for patients with targeted indication, to evaluate the benefit and risks relationship, and finally to provide sufficient data to support the registration approval of the drug. The trials usually are randomized, blind and controlled clinical trial with a large number of sample subjects.Phase IV: A new drug post-marketing study, conducted by the applicant. The objective is to investigate the efficacy and adverse reactions under the conditions of wide use, and to evaluate the benefit and risk relationship when used by ordinary and special groups of patients and to improve dosage of the drug.Bioequivalence trials means those human trails to determine if there is any statistical difference in absorption and absorption speed of active component between the same or different dosage form of the same drugs under the same test conditions, by using methodology of bioavailability study and with pharmacokinetic parameters.Article 32:The number of human subjects in the clinical study of a drug should be decided in accordance with the objective of the clinical trials and shall meet both the statistical requirements and the minimal cases required by this Regulation for a clinical study. For a drug used for the treatment of rare and special diseases or other special circumstances, any requirements for reduction in the number of human subjects in the clinical study or exemption should be made at the same time of clinical trial application and be approved by SFDA.Article 33:For a vaccine and other special drugs prepared during the strains selection stage, if there is indeed neither suitable animal experimental model nor a way to evaluate the efficacy of the drugs in laboratory study, application of clinical trials may made to SFDA, provided that safety of the subjects can be ensured.Article 34: After approval of a clinical study, the applicant shall select from the institutions qualified for drug clinical trial to conduct the clinical study.Article 35:The investigational drugs shall be produced in a workshop which meets GMP requirements and the production process shall be strictly in accordance with the requirements of GMP. The applicant is responsible for the drug quality of the investigational drugsArticle 36:The applicant may inspect the investigational drug itself in accordance with the drug's standards for its selected drugs for clinical trial, or authorize a drug control institute designated by this Regulation to conduct the quality test. Vaccine, blood products and other bio-products designated by SFDA must be inspected by a drug control institute designated by SFDA.The drug must not be used for Clinical Trails before it has passed the inspection.Drug administration authorities may conduct a random inspection for the investigational drug.Article 37:Before conducting the clinical study, the applicant shall file with SFDA information such as the clinical study protocol, name of the principle investigator of the leading institution, participating institutions and investigators, approval letter from ethics committee, and the sample of the Informed Consent Form, also providing a copy to the PDA where the institutions are located and PDA where the application was filed.Article 38: If an applicant discovers that an institution conducting clinical study is in violation of relevant regulations, or is not following the clinical study protocol, the applicant shall try to have the situation corrected. For serious violation, the applicant may request to suspend or stop the clinical study and shall submit a written report to SFDA and the relevant PDA. Article 39:Upon the completion of the clinical study, the applicant shall submit a clinical study summary report, statistical analysis report, and database to SFDA.Article 40: A clinical study shall start within 3 years of approval. Otherwise the approval certificate shall automatically become null and void.A re-application shall be submitted to resume the study.Article 41:Should any serious adverse event occur during clinical trails, the institutions should report to PDA, SFDA, as well as the applicant within 24 hours of occurrence, and timely report to the Ethics Committee. Article 42:SFDA may request the applicant to amend the clinical study protocol, suspend or stop the clinical study in any of the following circumstances:1)the Ethics Committee has failed to perform its duty; or;2)the safety of the subjects cannot be effectively ensured;3)serious adverse event was not timely reported;4)evidence that the investigative drug is not effective;5)quality problems in the drug used for clinical trials;6)fraud in the clinical study;7)other circumstances violating GCP.Article 43:During the clinical study, in case a large range or unexpected adverse reaction or serious adverse event occurs, or there is evidence to prove that the investigational drug has significant quality problems, SFDA or PDA may adopt emergency mandatory administrative measures to suspend or stop the clinical study, and the applicant and institutions must immediately stop the study.Article 44: A foreign applicant who wants to conduct an international multi–center clinical study shall apply at SFDA in accordance with the following provisions:1)The investigational drug used for an international multi–center clinicalstudy shall be one already registered in a foreign country or in phase II or phase III clinical trials. An application for an international multi–center clinical study of new preventive vaccine from a foreign applicant still not registered outside China shall not be accepted by SFDA.2)In approving an international multi–center clinical study in China, SFDAmay request the applicant to firstly conduct the Phase I clinical trials in China.3)During a study conducted in China, the Applicant shall, in accordancewith the relevant regulations, report to SFDA any serious adverse events or unexpected adverse events which occur in any countries.4)Upon the completion of the study, the Applicant shall submit thecomplete clinical study report to SFDA.5)Data generated from an international multi–center clinical trial, if usedfor drug registration in China, shall be in accordance with the relevant provision of this Regulation, and the applicant shall submit the complete research information of the study.Chapter 4: Application and Approval of New Drugs Article 45:SFDA may use special approval process for the following new drug, where detail regulation will be promulgated separately:1)New drug material and its preparation, active ingredients and itspreparation extracted from plant, animal and minerals, which have not been marketed in China and;2)chemical drug raw material and its preparations, and/or biologicalproduct that have not been marketed domestically or outside China;3)new drugs for AIDS, cancer and orphan disease that are superior to themarketed drugs.4)new drugs which treat diseases for which there is no effective therapy. For those drugs meeting the above provisions of this Regulation, during the drug registration, the applicant may apply for a special approval, SFDA shall organize specialist meeting to decide whether to use special approval for the drug application.Detailed provisions of special approval shall be promulgated separately. Article 46:When a new drug is jointly developed, the application shall be made by one of the parties, and other parties shall not apply in repetition. When a joint application needs to be made, the application shall be signed by all the parties. After approval, all the new drugs, including different strengths of the same drugs shall only be manufactured by one party. Article 47:For those registration applications of change in dosage form of drug but with no change in route of administration, new technology should be used to improve drug quality and safety, and there should be obvious clinical advantage in comparing with original dosage form. Except for targeted delivery preparation, sustained or controlled release preparation, the registration applications of change in dosage form of drug but with no change in route of administration should be made by the company with production condition.Article 48:During review process of new drug, even if the marketing approval of other drug of the same active substance is approved overseas, the registration category and technical requirements of the drug shall remain unchanged in the review process in China.During the review process of new drug, even when the marketing approval of other domestic drug of the same active substance is approved in China, the registration category and technical requirements of the same kind of drug shall remain unchanged in the review process in China.Article 49:Drug applicanion dossier should be submitted in one time, the applicant shall not self submit supplemental technical material to SFDA once any application is accepted, except for new information related to the drug safety or those special approval. If applicant considers the new technical materials must be added, the applicant should withdraw the application. When an applicant re-apply, the application procedures of this regulation should be met and there should not be any same drugs already entering into monitoring period..Section 1: Clinical Trials for New DrugsArticle 50:Upon the completion of the pre-clinical study, the applicant shall complete the Application Form for Registration of New Drugs, and submit the authentic dossier to the local PDA.Article 51:PDA shall examine the format of the application dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of non-acceptance notification of drug registration application, with explanation of reasons.Article 52:PDA shall, within 5 days upon acceptance of the application, organize and conduct on-site inspection of the drug research and the original data, conduct preliminary examination of the application dossier. If the drug to be registered is biological product, PAD shall take sample drugs of 3 batches, and notify the drug control institute for inspection.Article 53:PDA should, within the prescribed time limit, submit the examination recommendation, verification report and application dossier to the Center of Drug Evaluation of SFDA, and notify the applicant.Article 54:Drug control institute received the registration inspection notification should inspect the sample according to the drug standards submitted by the applicant, verify the drug standards, and submit the inspection report to Center of Drug Evaluation (CDE) of SFDA within the prescribed time limit, and copy applicant in.Article 55:Upon receipt of the application dossier, CDE of SFDA shall within the prescribed time, organize pharmaceutical, medical and other technical staff to conduct technical examination of the application dossier, and may request, with explanation of reason, the applicant to provide supplemental information and drug sample if necessary. After completing the technical examination, technical examination recommendation will be issued and submitted to SFDA along with the related application information.SFDA shall make approval decision based on the technical examination recommendation. When SFDA consider the requirements are met, Approval for Drug Clinical Study will be issued. When SFDA does not consider the requirements are met, Notification of Approval Opinion will be issued with explanation.Section 2: Production of New DrugArticle 56:After completion of a clinical study, the applicant shall fill out the Drug Registration Form, and submit production application dossier to the PDA where the applicant is located. At the same time, the applicant shall submit the raw material and research data related to standard substance for the preparation of the standard substance to NICPBP.Article 57:PDA shall examine for form the application dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of non-acceptance notification of drug registration application, with explanation of reasons.Article 58:PDA shall, within 5 days upon acceptance of the application, organize and conduct on-site inspection for the clinical trial and relevant original data, conduct preliminary review and issue examination recommendation. For those drugs other than biological product, PDA should also need to take sample of 3 batches of the drugs, and notify the drug control institute to verify the standards.PDA shall, within the prescribed time limit, submit its recommendations, inspection report and application dossier to CDE, and notify the applicant. Article 59:Drug control institute should verify the drug standards, and then submit the verification recommendation to CDE within the prescribed time limit, at the same time, copy in the PDA that issued the notification to verify, and copy the applicant in.Article 60:Upon receipt of the application dossier, CDE of SFDA shall within the prescribed time, organize pharmaceutical, medical and other technical staff to conduct technical examination of the application dossier, and may request, with explanation of reason, the applicant to provide supplemental information and drug sample if necessary.After the examination, if the related provisions are met, CDE shall notify the applicant to file application for on site inspection of production site, and notify the Centre for Certification Administration (CCA) of SFDA.After the examination, if the related provisions are not met, CDE shall submit the recommendation and application dossier to SFDA. SFDA shall make decision not to approve based on the technical examination recommendation, and Notification of Review Opinion will be issued with explanation.Article 61: Upon receipt of the notification of on site inspection of production site, applicant should file at CCA application for on site inspection of production site within 6 months..。
常用药品注册生产英文
缩写词API Active Pharmaceutical Ingredient原料药ANDA Abbreviated New Drug Application简化新药申请仿制药ASM The Active Substance Manufacturer原料药生产厂家ADE Adverse Drug Event药物不良事件ADR Adverse Drug Reaction药物不良反应CFDA China Food and Drug Administration中国国家食品药品监督管理局COS Certificate of Suitability欧洲药典适用性认证CTD Common Technical Documents通用技术文件COA Certificat of Analysis检验报告CDE Center for Drug Evaluation药品审评中心CMC Chemistry,Manufacture and Control化学，生产及质控CRO Contract Research Orgnization合同研究组织ChP Chinese Pharmacopoeia中国药典CAS Chemical Abstracts Service美国化学文摘社CTA Clinical Trail Application临床试验申请CMO Cheif Medical Officer首席医学官CPP Certificate of a Pharmaceutical Product药品证明文书CAPA Corrective and Preventive Action纠正预防行动DMF Drug Master File药品主文件EDMF European Drug Master File欧洲药物管理档案EMEA European Agency for the Evaluation of Medicinal Product欧洲药物评审局EU European Union欧洲联盟EP European Pharmacopoeia欧洲药典FDA Food and Drug Administration食品药品监督管理局（美国药监局）GMP Good Manufacturing Practices良好生产规范HPLC High Performance Liquid Chromatography高效液相ICH International Conference of Harmonization国际协调会议IND Investigational New Drug Application新药临床试验申请IDL Import Drug License进口药品注册证书INN International Nonproprietaty Name国际非专有名称LA Letter of Authorization委托书LOQ Limit of Quantity定量限LOD Limit of Detection检测限MA Marketing Authorization上市许可NDA New Drug Application新药生产上市申请NIFDC National Institutes for Food and Drug Control中国食品药品检定研究院NMT Not More Than不大于NA Not Analysis未检测OTC Over The Counter非处方药OOS Out of Specification不合格PSUR Periodic Safety Update Reports定期安全性报告QOS The Quality Overall Summary质量整体概述QA Qulitity Assurance质量保证QC Qulitity Control质量控制Rx Prescription Drug处方药RS Reference Standard对照品SOP Standard Operation Procedure标准操作规范TS Test Solutions指示剂UV Ultraviolet紫外分光光度法USP United States Pharmacopoeia美国药典药品注册词汇Drug registration application注册申请Supplementary application补充申请Drug regulatory department药品监管部门Re-registration application再注册On-site inspection现场核查Production site inspection生产现场核查Causal inspection有因核查Authenticity真实性Precision准确性Integrity完整性Entrusted agency代理机构Dosage form剂型Formula处方Preparing process生产工艺Testing methods检验方法Quality specifications质量指标Stability稳定性Drug approval number批准文号Method verification方法验证Manufacturer生产厂家Plant工厂Production line生产线Workshop车间Safety安全性Efficacy有效性Acceptance受理Applicant申请人Biological product生物制品Preliminary review初步审核Variation变更Raw data原始数据Specifications verification标准复核Second review复审GMP certificate生产质量管理规范证书Application dossers申请文件Center for food and drug inspection of CFDA CFDA食品药品审核查验中心产品英语部分streptococcus pneumoniae肺炎链球菌Streptococcus pyogenes酿脓性链球菌Branhamella catarrhalis卡他布兰汉姆菌staphylococcus aureus金黄色葡萄球菌Haemophilus influenzae type BB型流感嗜血杆菌Klebsiella pneumoniae肺炎克雷伯杆菌Manufacturing process生产过程Process control过程控制Lysate裂解物Culture培养培养基Ultrafiltration滤过，超滤Inactivation灭活Autolysis自溶Alkaline碱性的Bacterial strain菌株Revitalize复原，激活Sub-culture传代培养Inoculate嫁接Fermenter发酵器Cultivate培养Stir搅拌Concentrate浓缩Turbidity浑浊度Fungi真菌Elimination消除Identify鉴别Purity纯度Germ细菌，病菌Liter升Microbiological control微生物控制Thimerosal硫柳汞Sodium methyl-paraben对羟基苯甲酸甲酯钠Dose and uniformity of dose剂量及均一性Chlorhexidine diacetate乙酰乙酸氯已定Polysorbate80吐温80（聚山梨酯80）Antigenic activity抗原活性Rocket immunoeletroforesis火箭电泳法Excipient辅料Sterile distilled water无菌注射用水Purified water纯化水Appearance性状Container包装Surfactant表面活性剂Preservative防腐剂Leaflet说明书Active ingredients活性成分Approval documents批准证明文件Research data研究资料Stability稳定性Validation of method方法学验证。
国际药物注册英语词汇
国际药物注册英语词汇互译FDA(fooｄaｎd dｒug ａdmiｎistration):(美国)食品药品监督管理局NDA（ｎeｗdrug applicatiｏｎ):新药申请ANDＡ(abｂrｅviated new drug aｐpｌicatｉon）：简化新药申请EP（expoｒｔａpplicａtｉon）:出口药申请（申请出口不被批准在美国销售的药品）treaｔmｅnt ＩND：研究中的新药用于治疗aｂbreviaｔｅｄ(new）ｄｒug：简化申请的新药ＤＭF（ｄruｇmasｔer fiｌe）:药物主文件(持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DＭF持有者或授权代表以授权书的形式授权给FDA,ＦＤA在审查IND、NDA、AＮDA时才能参考其内容）holdｅr:DＭF持有者CＦＲ（cｏdｅof federaｌｒegｕlatioｎ）:(美国)联邦法规PANEＬ:专家小组ｂａｔch pｒｏduction：批量生产；分批生产batchｐｒoductioｎrecoｒdｓ:生产批号记录pｏst oｒpre-ｍarkｅt ｓurｖeillancｅ：销售前或销售后监督ｉnfｏrmed conｓｅnt:知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）ｐrescription ｄｒuｇ：处方药OＴC drｕg（oｖer—tｈe—cｏunｔer drｕg):非处方药U.Ｓ. ｐuｂlｉｃheaｌth servｉce：美国卫生福利部NIH(nａtional insｔitute of heaｌth):(美国）全国卫生研究所ａniｍaｌtrａｉl:动物试验ａccelerateｄaｐprｏｖａl：加速批准standardｄrug：标准药物invesｔiｇatoｒ：研究人员;调研人员prｅｐａring ａnｄsubmiｔｔinｇ:起草和申报submission：申报;递交bｅnｅｆit(s):受益riｓｋ（s）:受害drｕg ｐroduｃｔ：药物产品druｇsuｂstance:原料药establｉsｈed naｍe:确定的名称geｎericｎame：非专利名称ｐｒoprietary name：专有名称；INＮ(inｔeｒnａtｉｏｎal nonpropｒiｅtarｙname）：国际非专有名称naｒraｔive sｕmmarｙ: 记叙体概要adverｓe eｆfect:副作用adｖerｓeｒeactｉon：不良反应proｔocoｌ:方案archｉvaｌcopｙ:存档用副本reｖiｅｗcopｙ:审查用副本oｆfiｃiａl compenｄium:法定药典（主要指USP、NF)．USP(ｔhe unitｅd staｔe phaｒｍａｃopｅｉa):美国药典（现已和ＮＦ合并一起出版)NF（naｔioｎalｆormuｌary):(美国）国家药品集ｏｆｆiciａl=ｐhaｒmaｃopeiａl = cｏmpｅｎdｉal:药典的;法定的;官方的aｇenｃy:审理部门（指FＤA)sｐonsor：主办者（指负责并着手临床研究者)ideｎtitｙ：真伪；鉴别;特性sｔrength:规格;规格含量(每一剂量单位所含有效成分的量)labelｅｄamount:标示量ｒeｇｕｌａtory specｉficatｉon：质量管理规格标准(NDＡ提供）regｕｌatｏry methoｄｏlogy：质量管理方法(FDＡ用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）ｒegulａtory methods validatｉoｎ:管理用分析方法的验证(FDA对ＮDA提供的方法进行验证）Dietary ｓuｐｐｌｅmeｎt:食用补充品ＩCＨ(ＩnternaｔionaｌCoｎfｅrｅｎｃe on Ｈａrmｏnizatiｏn of Tec ｈnicａl Requiremｅｎts foｒＲｅgｉｓtrａtｉon oｆＰhaｒmaceutｉcalｓfoｒＨumanＵｓｅ）人用药物注册技术要求国际协调会议ICH：Quａｌity-质量Q１A(R２): Stability Ｔｅsting ｏf Ｎew Ｄrｕg Subｓtａncｅs ａnｄProdｕctｓ（SecｏndReｖiｓion）新原料药和制剂的稳定性试验（第二版）Ｑ1B: Photostabiliｔy Tｅｓtiｎｇof New Ｄrｕg Substancｅs and Prodｕcts新原料药和制剂的光稳定性试验Q１C:StabiliｔｙＴesting foｒNew Ｄosage Fｏrms新制剂的稳定性试验Q１D: Brａckeｔinｇａnd Ｍａtｒixing Deｓigｎs for Ｓtabiｌity Tesｔing oｆDrugSubstａncｅs and DｒuｇProdｕcｔs原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluatｉon of StaｂｉｌiｔｙDaｔa对稳定性数据的评估处理Q１Ｆ:StａbiliｔｙDatａPackａge fｏｒRegistraｔionＡppｌicaｔions iｎＣｌimaｔｉｃZones III anｄIV在气候带III和IV,药物注册申请所提供的稳定性数据Q2A: Teｘt on Ｖaｌidation of Analyｔｉcal Pｒｏceｄures分析程序的验证Q２B: Ｖalｉdａtｉon of AnalytｉcaｌＰrｏｃｅdurｅｓ:Ｍeｔhodo ｌoｇy分析程序的验证:方法学Ｑ3A（R)：Impuritieｓｉn Nｅw ＤruｇＳｕｂstａnces (ＲeｖiseｄG ｕiｄeline)新原料药中的杂质(修订版）Q3B(R): Impurｉｔies in New Ｄｒug Prｏｄucts （Ｒevised Guideline)新制剂中的杂质（修订版)Q3C: Impuriｔies: Guidｅｌine fｏｒＲｅsidual Ｓolventｓ杂质：残留溶剂指南Q3C(Ｍ）:Ｉmｐurities: Ｇｕｉdeｌine ｆor RｅｓｉduａｌSolventｓ（Maｉntenａnce)杂质:残留溶剂指南(修改内容)Q4: Phaｒmaｃopoｅias药典Q4Ａ：Pｈarmａcｏpoeial Harｍoｎiｓaｔion药典的协调Q４Ｂ:Reｇulatory Accｅｐtａnce ofＰharmａｃopoｅial Iｎteｒｃhangeaｂiｌity药典互替在法规上的可接受性Q5Ａ: Viral Ｓａｆｅty Evａluation ｏfＢiotechｎｏloｇy ProｄｕcｔsＤeriｖｅd from ＣellLiｎes of Human ｏr ＡｎimaｌOriｇin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quａliｔy ｏf Ｂiotechnologｉcal Proｄuｃts:Analysｉs of ｔhｅEｘpressionConｓtruct in Cells Ｕsｅｄfor Ｐroduｃtｉon ｏｆr-DＮA Deｒived Pｒotｅin Productｓ生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Ｑ5Ｃ：Qｕaliｔy of Bｉotechｎological Pｒoducts: Ｓtabｉlity TｅsｔinｇofＢiotechnｏlｏgical/BioｌogiｃaｌProducts生物技术产品的质量:生物技术／生物产品的稳定性试验Q5D：Dｅｒｉｖatｉon and Chａraｃterisationｏf Ｃell Sｕbｓtrａtes Ｕsed fｏｒＰroｄuctioｎoｆＢｉｏｔecｈnologiｃaｌ／BioloｇicaｌＰrodｕctｓ用于生产生物技术/生物产品的细胞底物的起源和特征描述Ｑ5E：Comparａｂility of Ｂiotｅchｎｏlogｉcal/Biｏlｏgｉｃal Pro ｄucｔs SubjｅｃtｔｏCｈangｅs in Their Ｍａnufａcｔuriｎg Ｐｒｏcesｓ基于不同生产工艺的生物技术产品/生物产品的可比较性Q６: Sｐecｉficａtｉons fｏr New Dｒug Sｕbstａnces and Prｏductｓ新原料药和制剂的质量规格Q6Ａ: Sｐecｉficａｔiｏns:ＴesｔProcedurｅｓａｎd AｃcｅpｔanceＣｒiteｒｉa for New DrugSubstaｎces aｎd Nｅw Drｕg Produｃts: Chemical Suｂｓtaｎcｅs质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质Ｑ6Ｂ: Specｉｆｉｃａｔioｎs: TeｓｔProcedｕreｓａnd Acｃepｔａnce Criteria forBｉｏｔechnolｏgical/BiｏloｇicaｌＰroｄucts质量规格：生物技术／生物产品的检验程序和可接收标准Q7:Gｏod Manufactｕring Ｐｒacｔices fｏｒPharmaｃｅuｔical Ingrｅdｉeｎtｓ活性药物成份的GMPQ7A: Good ＭanufacturｉnｇPractｉce Ｇｕide foｒActivｅＰｈａrｍaceutｉcalIｎｇｒedｉeｎts活性药物成份的GMP指南Q8：Pｈａrmaceuｔical Develｏｐmeｎt药物研发Ｑ9: Ｑualiｔy Risk Ｍanａｇement质量风险管理ICH:Saｆety-安全S１A：Guｉdeliｎe onｔhｅNｅed fｏrＣaｒcinogenicｉty Stｕdies ofＰhaｒmaceｕticａls药物致癌性研究需要的指南S1B:Tｅｓｔing for Ｃａrciｎogenｉｃity of Pharmａｃeuｔicals药物致癌性的检验S1C:DosｅＳeｌeｃｔiｏn ｆｏr Carcｉnogｅｎiｃity Stｕdies o ｆPhaｒｍａｃｅutiｃals药物致癌性研究之剂量选择S1C（R)：Adｄｅndｕm: Addｉｔｉｏn of a LiｍｉｔＤｏse ａndＲelａted Notｅｓ附录：极限剂量和有关注释的的补充Ｓ2Ａ:Guidａｎｃe on Specific Aspeｃts ｏf ＲegｕlatoryＧeｎotoｘiciｔｙTestｓfoｒＰharmacｅutiｃals受法规管辖的药物基因毒性检验的特定方面的指南Ｓ2Ｂ：Geｎotoxｉｃitｙ: A Standａｒd Batｔery foｒGenotoｘici ｔy Tesｔing ｆｏrPharmacｅuｔicals基因毒性：药物基因毒性检验的标准S3A：Note for Guiｄancｅon Tｏxicokinｅtics: The Assessment of SystemiｃExｐｏsurｅｉｎToxｉcｉtｙSｔudieｓ毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3Ｂ:Pharmacokinｅtics: Guidancｅfor Reｐeated Dose Tｉssｕe D ｉｓtributionStｕdiｅｓ药物代谢动力学：重复剂量的组织分布研究指南S4: Ｓinｇle DoseＴoxicitｙTｅsts单剂量毒性检验S4Ａ: Ｄuratｉon of Chrｏnic Toxicity Ｔestiｎg in Aniｍａlｓ(Rodeｎt anｄNoｎ-Roｄent Toｘiｃiｔy Tｅstiｎg）动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验)S5Ａ: Ｄｅteｃtion of Toxiｃity to Ｒeprｏducｔion forＭedicinａl Ｐroducts药物对生殖发育的毒性的检验S5B(M）：Maiｎtenａnｃe oｆthe ICH Guidｅｌiｎe ｏnＴoxicity t ｏMaleＦeｒtｉlity:An Adｄendum tｏｔhe Guidelｉne onＤetecｔion of Toxiｃity to ReprodｕcｔioｎforMeｄicｉnａl Pｒｏｄucts对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录Ｓ６:Ｐrｅｃｌinical Safety Evａluaｔioｎof Biｏtecｈnology-Ｄerived Pharmacｅｕtiｃaｌs生物技术生产的药物的临床前安全评价S7A：Saｆety Pharmacolｏgy Sｔudieｓfｏr Human Pｈarmaceｕtｉcalｓ人用药的安全药理学研究S7B: The Noncliｎical Eｖaluａtioｎof ｔｈeＰoｔentiaｌｆor D ｅlayed VentｒicuｌarRｅｐoｌarｉzａｔｉon（QＴIｎterval Prolｏｎgatｉon) ＢyＨｕman Phａrmaceuticaｌs药物延迟心室复极化(QT间期）潜在作用的非临床评价S８：Ｉmｍｕnｏｔｏｘicoｌｏgy Ｓtudies ｆoｒHuman Pｈaｒmaceut ｉcals人用药免疫毒理学研究M３（M):Ｍａｉｎtenａncｅof thｅICH Gｕiｄｅline on Nｏn-Ｃｌｉnicａl Saｆｅty Ｓtudies foｒthｅConduｃｔoｆHuman CｌinicaｌTriａｌs fｏｒＰhaｒmａceu ｔｉcalｓ药物的对人临床试验的非临床安全研究指南的变动Ｅ-Efficａcy（有效)E1: Tｈe Extent ｏf Popuｌatｉｏn Ｅxposure toＡssess Cｌiｎiｃal Ｓaｆｅｔy for ＤｒugｓIntended for Lｏng-Ｔｅrm Ｔreａtment ｏf Nｏn－Liｆe-Threaｔening Cｏndｉtions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A:Clinical SａfetｙData Manaｇｅmenｔ: Ｄefｉｎiｔioｎs and Ｓｔandards forＥxpediｔｅｄＲeｐoｒting临床安全数据管理:速报制度的定义和标准E2B（R)：Rｅvisionｏf ｔhe Ｅ２B(M）ＩCＨGuideliｎeｏn Clｉnｉcａl SaｆetyＤataＭanagemenｔDａｔａElemｅnts foｒTransmｉssioｎof Ｉｎdivid ｕal Case SafeｔyRｅｐoｒts个案安全报告送交的临床安全数据管理的数据要素指南(E2B（M)）的修订版E２B （M)：Mａｉｎtenaｎｃe ｏf the Clｉnｉcal SaｆｅtｙDat ａMａnagement iｎcludｉｎg:Data ElementｓfoｒTｒansmissioｎof IndiｖｉduａｌCａse Sａfety Rｅpoｒｔｓ临床安全数据管理的变动包括：个案安全报告送交的数据要素E２B(Ｍ)：Ｍａinｔenanｃe of thｅCliniｃａl Sａfｅty DaｔａMａｎa ｇemｅnt incｌudiｎｇＱｕestiｏｎs and Ａnｓwerｓ临床安全数据管理的变动,包括问答E2Ｃ: Cｌiniｃａl SａｆeｔｙDatａＭａnagｅment:Pｅｒioｄic Sa ｆety UpdateＲeporｔs ｆorMarkｅｔed Drｕgs临床安全数据管理：已上市药品的周期性安全数据更新报告Ａdｄenｄum tｏE２Ｃ: Periodic Safety Update RepｏrtｓfoｒMarketｅd DrugsE2C的附录:已上市药品的周期性安全数据更新报告E２D: Pｏst－Apｐrｏval Safeｔy DataＭａｎagemｅｎt：Ｄefｉni ｔｉｏns ａｎｄSｔandａrｄs forＥxpeｄiｔｅd Reｐｏｒtiｎg批准后的安全数据管理:速报制度的定义和标准E2E:PhaｒmacoviｇiｌａncｅPlaｎning药物警戒计划E３:Sｔrｕcture ａnd ＣontenｔｏｆClｉniｃａl Sｔudy Reｐorts临床研究报告的结构和内容E4: Ｄｏse-Respoｎse Iｎfｏrmaｔion to Support Ｄrｕg Ｒegｉstrａｔion支持药品注册的剂量-效应资料E5:Ethnic Ｆactoｒｓinｔhe ＡccepｔaｂilityｏfＦorｅiｇn ClinｉcａｌＤata引入海外临床数据时要考虑的人种因素Ｅ6: GｏｏｄCｌiｎical Pｒactice: Consｏliｄａｔed Guideｌine ＧCＰ：良好的临床规范：统一的指南E７: Sｔudiｅs inＳupport of Ｓpeｃial Pｏpｕlａtioｎｓ: Gerｉatrics对特定族群的支持的研究:老人病学E８: Gｅneral Consiｄeratｉoｎs for Clinical Trialｓ对临床试验的总的考虑E9: Statｉstical Princiｐｌeｓfor CｌiｎicａｌTrｉａlｓ临床试验的统计原则E１0: Choice of ControｌGｒoup and Rｅｌated Issｕeｓｉn Cliniｃal Trials临床试验中控制组和有关课题的选择E１１: Clinicａl Investigaｔｉonｏf MｅdicinaｌＰｒoducts in the ＰediatricＰopｕｌatｉon小儿科药物的临床调查E１2A：Princiｐlｅs fｏｒＣlｉnical Evaluaｔion ｏf Nｅw Ａntihyp ｅｒtenｓivｅDrｕgs新抗高血压药物的临床评价原则E14: ThｅClinical EｖaluaｔioｎｏｆQＴ/ＱＴｃInteｒｖal Pｒolongatiｏn andPrｏaｒrhythｍｉc Ｐotｅnｔial ｆｏr Noｎ-Antiarrhythmic Drugs非抗心率失常药物的QT/ＱTc间期和致心率失常潜在作用的临床评价ＭｕltidisｃiｐｌinａrｙＧuidｅｌｉｎeｓ多学科兼容的指南M１:ＭedｉcaｌTｅｒminology医学术语M２: ＥｌeｃtronｉｃSｔandards fｏr Ｔranｓmissiｏn of ＲegulaｔoryＩnfｏrmatiｏn（ＥSＴRI)药政信息传递之电子标准Ｍ3：ＴimingｏｆＰre-cliniｃalＳtｕdies in Ｒelatｉoｎｔo Cli ｎical Ｔrｉals（SeeSａfｅtyＴｏpicｓ)有关临床试验的临床前研究的时间安排M４: The Common Techｎical Docuｍent （Sｅe CＴD seｃｔioｎfｏrｃｏmpletｅStatus ofthｅguidelｉnes）通用技术文件(见有关CTD章节)Ｍ5:Data Eｌeｍｅnts and Stａndａrds for ＤrugＤｉctionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP：time-to－proｇresｓｉon疾病进展时间SAE: seｖeriｔy Aｄveｒｓe Evｅnt 严重不良事件AE：ＡdveｒｓｅEｖｅnt 不良事件SOP：Staｎdard OｐeratinｇProcedｕｒｅ标准操作规程ＣＲＦ：Cａse Rｅport foｒm病例报告表ＤLＴ: 剂量限制毒性MTD: 最大耐受剂量KPS：Ｋａrnｏｆｓky Ｐerfoｒmaｎce Ｓｔatus行为状态评分CR：complｅteｒｅsponsｅ完全缓解PR: partiａl ｒesponse部分缓解SD：病情稳定PD：pｒoｇressive diｓeａse病情进展CTC: 常用药物毒性标准IＥC: indｅpｅndent ethics committｅｅ独立伦理委员会IRB ：ｉｎstituｔｉｏnal reｖiew boａｒd伦理委员会ＣRA: 临床研究助理ＣRＯ：Contrａct Ｒeseａrch Orｇaniｚation 合同研究组织ＤFＳ: Diseａse Frｅe Sｕrvival 无病生存期OS：（OvｅｒａlｌSurvivａl)总生存时间ＩC: Iｎformed ｃonｓｅnt知情同意ADR: Ａｄverｓe Drｕg Rｅaｃｔion不良反应GAＰ:ＧｏoｄAｇｒiｃulturaｌPracｔice中药材种植管理规范ＧCP:Good Clｉnicａl Practice 药物临床试验质量管理规范GLP:Good Ｌａbｏratoｒy Prａctice 药品实验室管理规范GMP:Good Ｍａｎuｆacturｉng Praｃticｅ药品生产质量管理规范ＧＳＰ:Good Supply Praｃtice药品经营质量管理规范ＧUP：Ｇood Use Praｃtice 药品使用质量管理规范PI：Principal inｖestigator 主要研究者ＣI：Co－iｎｖeatigａｔor 合作研究者SI ：Sｕb-invesｔｉgator 助理研究者CＯI :Ｃｏoｒdinating inｖｅｓtiｇtoｒ协调研究者DＧMP:医疗器械生产质量管理规范ICＦ: Ｉnｆoｒmed conｓenｔforｍ知情同意书RCT : randｏmizedｃontrolleｄtｒiａl, 随机对照试验NRＣCT：nｏn-rａndｏmized concurrｅntｃontrolleｄtrｉａl, 非随机同期对照试验ＥBＭ：evidenｃe-ｂasｅd meｄicine 循证医学RCD：randomized croｓs-over disgｎ随机交叉对照试验HCT: historial ｃontrolｔrial,历史对照研究RECISＴ: Ｒｅｓpoｎse Ｅvaluation CriｔeriａＩn Solid Tｕmｏrs．实体瘤疗效反应的评价标准QＣ：Quａlｉty Cｏnｔｒol质量控制ＵＡDR: UnexｐectｅｄAｄverse Dｒｕg Reacｔｉon，非预期药物不良反应。
医药常用英语单词及缩写
FDA（food and drug adminisration）：（美国）食品药品监督管理局NDA（new drug application）：新药申请ANDA（abbreviated new drug application）：简化新药申请EP（export application）：出口药申请（申请出口不被批准在美国销售的药品）treatment IND：研究中的新药用于治疗abbreviated（new）drug：简化申请的新药DMF（drug master file）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）holder：DMF持有者CFR（code of federal regulation）：（美国）联邦法规PANEL：专家小组batch production：批量生产；分批生产batch production records：生产批号记录post or pre-market surveillance：销售前或销售后监督informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U.S. public health service：美国卫生福利部NIH（national institute of health）：（美国）全国卫生研究所animal trail：动物试验accelerated approval：加速批准standard drug：标准药物investigator ：研究人员；调研人员preparing and submitting：起草和申报submission：申报；递交benefit(s)：受益risk（s）：受害drug product：药物产品drug substance：原料药established name：确定的名称generic name：非专利名称proprietary name：专有名称；INN（international nonproprietary name）：国际非专有名称narrative summary: 记叙体概要adverse effect：副作用adverse reaction：不良反应protocol：方案archival copy：存档用副本review copy：审查用副本official compendium：法定药典（主要指USP、NF）．USP（the united state pharmacopeia）：美国药典（现已和NF合并一起出版）NF（national formulary）：（美国）国家药品集official＝pharmacopeial = compendial：药典的；法定的；官方的agency：审理部门（指FDA）sponsor：主办者（指负责并着手临床研究者）identity：真伪；鉴别；特性strength：规格；规格含量（每一剂量单位所含有效成分的量）labeled amount：标示量regulatory specification：质量管理规格标准（NDA提供）regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH：Quality-质量Q1A(R2): Stability Testing of New Drug Substances and Products (SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of DrugSubstances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in ClimaticZones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证：方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质（修订版）Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质（修订版）Q3C: Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质：残留溶剂指南（修改内容）Q4: Pharmacopoeias药典Q4A: PharmacopoeialHarmonisation药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from CellLines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the ExpressionConstruct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing ofBiotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject toChanges in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New DrugSubstances and New Drug Products: Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria forBiotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active PharmaceuticalIngredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH：Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests forPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing forPharmaceuticals基因毒性：药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of SystemicExposure in Toxicity Studies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue DistributionStudies药物代谢动力学：重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic Toxicity Testing in Animals (Rodent andNon-Rodent Toxicity Testing)动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A: Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility:An Addendum to the Guideline on Detection of Toxicity to Reproduction forMedicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed VentricularRepolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy（有效）E1: The Extent of Population Exposure to Assess Clinical Safety for DrugsIntended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards forExpedited Reporting临床安全数据管理：速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety DataManagement Data Elements for Transmission of Individual Case SafetyReports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B (M): Maintenance of the Clinical Safety Data Management including:Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management includingQuestions and Answers临床安全数据管理的变动，包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports forMarketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量－效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP：良好的临床规范：统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究：老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the PediatricPopulation小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (SeeSafety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status of the guidelines)通用技术文件（见有关CTD章节）M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP：time-to-progression 疾病进展时间SAE：severity Adverse Event 严重不良事件AE：Adverse Event 不良事件SOP：Standard Operating Procedure 标准操作规程CRF：Case Report form 病例报告表DLT：剂量限制毒性MTD：最大耐受剂量KPS：Karnofsky Performance Status行为状态评分CR：complete response完全缓解PR：partial response部分缓解SD：病情稳定PD：progressive disease病情进展CTC：常用药物毒性标准IEC：independent ethics committee 独立伦理委员会IRB ：institutional review board 伦理委员会CRA：临床研究助理CRO：Contract Research Organization 合同研究组织DFS：Disease Free Survival 无病生存期OS：（Overall Survival）总生存时间IC：Informed consent 知情同意ADR：Adverse Drug Reaction 不良反应GAP：Good Agricultural Practice 中药材种植管理规范GCP：Good Clinical Practice 药物临床试验质量管理规范GLP：Good Laboratory Practice 药品实验室管理规范GMP：Good Manufacturing Practice 药品生产质量管理规范GSP：Good Supply Practice 药品经营质量管理规范GUP：Good Use Practice 药品使用质量管理规范PI ：Principal investigator 主要研究者CI：Co-inveatigator合作研究者SI ：Sub-investigator 助理研究者COI ：Coordinating investigtor协调研究者DGMP：医疗器械生产质量管理规范ICF：Informed consent form 知情同意书RCT ：randomized controlled trial, 随机对照试验NRCCT：non-randomized concurrent controlled trial, 非随机同期对照试验EBM：evidence-based medicine 循证医学RCD：randomized cross-over disgn随机交叉对照试验HCT：historial control trial, 历史对照研究RECIST：Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC：Quality Control质量控制UADR：Unexpected Adverse Drug Reaction，非预期药物不良反应。
医药常用英语单词及缩写
FDA（food and drug adminisration）：（美国）食品药品监督管理局NDA（new drug application）：新药申请ANDA（abbreviated new drug application）：简化新药申请EP（export application）：出口药申请（申请出口不被批准在美国销售的药品）treatment IND：研究中的新药用于治疗abbreviated（new）drug：简化申请的新药DMF（drug master file）：药物主文件（持有者为谨慎起见而准备的资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA 在审查IND、NDA、ANDA时才能参考其容）holder：DMF持有者CFR（code of federal regulation）：（美国）联邦法规PANEL：专家小组batch production：批量生产；分批生产batch production records：生产批号记录post or pre-market surveillance：销售前或销售后监督informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U.S. public health service：美国卫生福利部NIH（national institute of health）：（美国）全国卫生研究所animal trail：动物试验accelerated approval：加速批准standard drug：标准药物investigator ：研究人员；调研人员preparing and submitting：起草和申报submission：申报；递交benefit(s)：受益risk（s）：受害drug product：药物产品drug substance：原料药established name：确定的名称generic name：非专利名称proprietary name：专有名称；INN（international nonproprietary name）：国际非专有名称narrative summary: 记叙体概要adverse effect：副作用adverse reaction：不良反应protocol：方案archival copy：存档用副本review copy：审查用副本official compendium：法定药典（主要指USP、 NF）．USP（the united state pharmacopeia）：美国药典（现已和NF合并一起出版）NF（national formulary）：（美国）国家药品集official＝pharmacopeial = compendial：药典的；法定的；官方的agency：审理部门（指FDA）sponsor：主办者（指负责并着手临床研究者）identity：真伪；鉴别；特性strength：规格；规格含量（每一剂量单位所含有效成分的量）labeled amount：标示量regulatory specification：质量管理规格标准（NDA提供）regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）regulatory methods validation：管理用分析方法的验证（FDA对NDA提供的方法进行验证）Dietary supplement：食用补充品ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH：Quality-质量Q1A(R2): Stability Testing of New Drug Substances and Products (SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B: Photostability Testing of New Drug Substances and Products 新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证：方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质（修订版）Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质（修订版）Q3C: Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance) 杂质：残留溶剂指南（修改容）Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability 药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from CellLines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject toChanges in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New DrugSubstances and New Drug Products: Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices for Pharmaceutical Ingredients 活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH：Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals 药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests forPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals基因毒性：药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies毒物代动力学指南的注释：毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue DistributionStudies药物代动力学：重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)动物体慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A: Detection of Toxicity to Reproduction for Medicinal Products 药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility:An Addendum to the Guideline on Detection of Toxicity to Reproduction forMedicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed VentricularRepolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies forthe Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy（有效）E1: The Extent of Population Exposure to Assess Clinical Safety for DrugsIntended for Long-Term Treatment of Non-Life-Threatening Conditions 对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量围E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting临床安全数据管理：速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case SafetyReports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B (M): Maintenance of the Clinical Safety Data Management including:Data Elements for Transmission of Individual Case Safety Reports 临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management including Questions and Answers临床安全数据管理的变动，包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports forMarketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs E2C的附录：已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards forExpedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量－效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data 引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP：良好的临床规：统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究：老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials 临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status ofthe guidelines)通用技术文件（见有关CTD章节）M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP： time-to-progression 疾病进展时间SAE： severity Adverse Event 严重不良事件AE： Adverse Event 不良事件SOP： Standard Operating Procedure 标准操作规程CRF： Case Report form 病例报告表DLT：剂量限制毒性MTD：最大耐受剂量KPS： Karnofsky Performance Status行为状态评分CR： complete response完全缓解PR： partial response部分缓解SD：病情稳定PD： progressive disease病情进展CTC：常用药物毒性标准IEC： independent ethics committee 独立伦理委员会IRB ： institutional review board 伦理委员会CRA：临床研究助理CRO： Contract Research Organization 合同研究组织DFS： Disease Free Survival 无病生存期OS：（Overall Survival）总生存时间IC： Informed consent 知情同意ADR： Adverse Drug Reaction 不良反应GAP：Good Agricultural Practice 中药材种植管理规GCP：Good Clinical Practice 药物临床试验质量管理规GLP：Good Laboratory Practice 药品实验室管理规GMP：Good Manufacturing Practice 药品生产质量管理规GSP：Good Supply Practice 药品经营质量管理规GUP：Good Use Practice 药品使用质量管理规PI ：Principal investigator 主要研究者CI： Co-inveatigator 合作研究者SI ：Sub-investigator 助理研究者COI ：Coordinating investigtor 协调研究者DGMP：医疗器械生产质量管理规ICF： Informed consent form 知情同意书RCT ： randomized controlled trial, 随机对照试验NRCCT： non-randomized concurrent controlled trial, 非随机同期对照试验EBM： evidence-based medicine 循证医学RCD： randomized cross-over disgn 随机交叉对照试验HCT： historial control trial, 历史对照研究RECIST： Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC： Quality Control质量控制UADR： Unexpected Adverse Drug Reaction，非预期药物不良反应。
注册用英文缩写
T/T
Telegraphic Transfer
电汇
L/C
Letter of Credit
PK
Pharmacokinetics
PD
pharmacodynamic
信用证
药代动力学 药效动力学
解释
CFR价=FOB价+运费 CIF价=FOB价+运费+保险 CIF价=CFR价/[1-(1+投保加成)×保险费率]
注册 外贸 外贸
外贸 注册 注册
bioequivalence
Certificate of Analysis
中文名 国家食品药品监督管理总局 药品评审中心 国家食品药品监督管理总局 卫生部 成本加运费 成本加保险费加运费，到岸 价 离岸价 最低订货数量
生物等效性
品质分析证书ຫໍສະໝຸດ CPPCertificate of Pharmaceutical Product 药品证书
IDL PIC/s
imported drug license Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme
PIC/S GMP
EXW
EX-Works
药品经营质量管理规范 进口药品注册证 国际药品认证合作组织
分类 机构 机构 机构 外贸 外贸 外贸 外贸 注册 注册
注册
注册 注册
注册
注册
注册 注册
注册
是迄今全球最严谨的GMP规范，因此实施PIC/S GMP后，可进一步提高 药品质量，保障用药安全。
是指汇出行应汇款人申请，拍发加押电报\电传或SWIFT给在另一国家的 分行或代理行（即汇入行）指示解付一定金额给收款人的一种汇款方式 。 是指开证银行应申请人的要求并按其指示向第三方开立的载有一定金额 的、在一定的期限内凭符合规定的单据付款的书面保证文件。信用证是 国际贸易中最主要、最常用的支付方式。