SFDA药品包装标签规范细则-24号令英文版-Provisions for Drug Insert Sheets and Labels
(国食药监注[2007]49号)24号令
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关于《药品说明书和标签管理规定》有关问题解释的通知（国食药监注[2007]49号）各省、自治区、直辖市食品药品监督管理局（药品监督管理局）：《药品说明书和标签管理规定》（局令24号，以下简称《规定》）及其实施公告（国食药监注〔2006〕100号）、《关于进一步规范药品名称管理的通知》（国食药监注〔2006〕99号）发布后，国家局陆续收到一些省局、协会以及企业的来函，要求对其中的部分内容进行解释。
经研究，现就有关问题明确如下。
（一）药品说明书和标签修改的补充申请已经批准注册的药品，其说明书和标签的格式、内容不符合《规定》的，均应当根据《关于实施〈药品说明书和标签管理规定〉有关事宜的公告》（以下简称《公告》）的要求提出补充申请。
化学药品、生物制品说明书和标签修改的补充申请按照《药品注册管理办法》关于补充申请的要求执行。
国产药品由省级药品监督管理部门受理和审批并报国家局备案，省级药品监督管理部门审批日期为核准日期。
进口药品由国家局受理和备案，备案日期为核准日期。
进口分包装药品的说明书和标签应在进口药品说明书和标签同意备案后，报省级药品监督管理部门审批，其内容除分包装信息外，应当与进口药品的说明书和标签一致。
中药、天然药物说明书和标签修改的补充申请按照《关于印发中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知》（国食药监注〔2006〕283号）执行。
非处方药说明书和标签修改的补充申请按照《药品注册管理办法》的要求执行,进口药品由国家局受理和备案，备案日期为修订日期。
药品生产企业提出补充申请时提交的药品说明书和标签可以是实样，也可以是设计样稿。
（二）药品名称的使用药品通用名称必须使用黑色或者白色，不得使用其他颜色。
浅黑、灰黑、亮白、乳白等黑、白色号均可使用，但要与其背景形成强烈反差。
根据《关于进一步规范药品名称管理的通知》（国食药监注〔2006〕99号），自2006年6月1日起，属于下列情形的药品可以申请使用商品名称：1.新化学结构、新活性成份且在保护期、过渡期或者监测期内的药品；2.在我国具有化合物专利，且该专利在有效期内的药品。
药品包装标签和说明书管理规定模版
药品包装标签和说明书管理规定模版第一章总则第一条目的和依据（一）为了规范药品包装标签和说明书的管理，确保药品的安全性、有效性和合理使用，保护患者的权益，根据相关法律法规，制定本规定。
（二）本规定适用于中华人民共和国境内生产的药品，以及进口药品在我国注册。
第二章药品包装标签的管理第二条标签要求（一）药品包装标签应当包括以下内容：1. 药品名称，中文为药品通用名，英文为药品英文名称；2. 药品剂型，如片剂、胶囊、注射剂等；3. 药品规格，如每片含几毫克等；4. 生产厂家名称和地址；5. 批准文号，可标注中药保证证书、药食同源产品标示等；6. 生产日期和有效期；7. 使用方法和注意事项；8. 不良反应和禁忌症；9. 药品储存条件；10. 执行标准；11. 化学成分，如需要标示；12. 其他必要信息。
第三条标签设计（一）药品包装标签设计应当符合以下要求：1. 易于辨认，清晰可见；2. 字体大小适中，不得小于一定的尺寸；3. 使用易懂的词语和图示，便于患者理解；4. 标签上的信息应当准确无误，不得存在错误或模糊的信息；5. 通过特定的方式标识特殊信息，如禁忌症、特殊人群使用注意等。
第三章药品说明书的管理第四条说明书要求（一）药品说明书应当包括以下内容：1. 药品名称，中文为药品通用名，英文为药品英文名称；2. 药品剂型，如片剂、胶囊、注射剂等；3. 药品规格，如每片含几毫克等；4. 生产厂家名称和地址；5. 批准文号，可标注中药保证证书、药食同源产品标示等；6. 主要成分和成分含量；7. 药理作用和适应症；8. 用法用量和使用方法；9. 不良反应和禁忌症；10. 药物相互作用；11. 药物储存条件；12. 药物过量和处理方法；13. 执行标准；14. 其他必要信息。
第五条说明书设计（一）药品说明书设计应当符合以下要求：1. 逻辑清晰，各项内容排版合理；2. 使用易懂的词语和图示，便于患者理解；3. 字体大小适中，不得小于一定的尺寸；4. 通过特定的方式标识特殊信息，如禁忌症、特殊人群使用注意等。
SFDA药包材标准汇编目录
标准名称SFDA 药包材标准汇编（第一辑,2002年7月）低密度聚乙烯输液瓶（试行）聚丙烯输液瓶（试行）钠钙玻璃输液瓶（试行）药用氯化丁基橡胶塞（试行）(20050415起废止）药用溴化丁基橡胶塞（试行） (20050415起废止）低密度聚乙烯药用滴眼剂瓶（试行）聚丙烯药用滴眼剂瓶（试行）口服液体药用聚丙烯瓶（试行）口服液体药用高密度聚乙烯瓶（试行）口服液体药用聚酯瓶（试行）口服固体药用聚丙烯瓶（试行）口服固体药用高密度聚乙烯瓶（试行）药品包装用复合膜、袋通则（试行）药品包装材料与药物相容性试验指导原则低密度聚乙烯输液瓶质量标准的起草说明 聚丙烯输液瓶质量标准的起草说明钠钙玻璃输液瓶质量的起草说明 药用氯化丁基橡胶塞质量标准的起草说明药用溴化丁基橡胶塞质量标准的起草说明低密度聚乙烯药用滴眼剂瓶质量标准的起草说明聚丙烯药用滴眼剂瓶质量标准的起草说明口服液体药用聚丙烯瓶质量标准的起草说明口服液体药用高密度聚乙烯瓶质量标准的起草说明口服液体药用聚酯瓶质量标准的起草说明口服固体药用聚丙烯瓶质量标准的起草说明口服固体药用高密度聚乙烯瓶质量标准的起草说明书药品包装用复合膜、袋通则质量标准的起草说明药品包装材料与药物相性试验指导原则质量标准的起草说明SFDA 药包材标准汇编（第二辑，2003年1月）关于颁布药品包装用铝箔等20项药包材标准（试行）的通知药品包装用铝箔（试行）药品包装用铝箔质量标准的起草说明铝质药用软膏管（试行）铝质药用软膏管质量标准的起草说明聚酯/铝/聚乙烯药品包装用复合膜、袋（试行）聚酯/铝/聚乙烯药品包装用复合膜、袋质量标准的起草说明聚酯/低密度聚乙烯药品包装用复合膜、袋（试行）聚酯/低密度聚乙烯包装用复合膜、袋质量标准的起草说明双向拉伸聚丙烯/低密度聚乙烯药品包装用复合膜、袋（试行）双向拉伸聚丙烯/低密度聚乙烯药品包装用复合膜、袋质量标准的起草说明聚氯乙烯/聚乙烯/聚偏二氯乙烯固体药用复合片（试行） (20050202起废止）聚氯乙烯/聚乙烯/聚偏二氯乙烯固体药用复合硬片质量标准的起草说明聚氯乙烯固体药用硬片（试行） (20050202起废止）聚氯乙烯固体药用硬片质量标准的起草说明聚氯乙烯/聚偏二氯乙烯固体药用复合硬片（试行） (20050202起废止）聚氯乙烯/聚乙烯/聚偏二氯乙烯固体药用复合硬片质量标准的起草说明聚氯乙烯 /低密度聚乙烯固体药用复合硬片（试行） (20050202起废止）聚氯乙烯/低密度聚乙烯固体药用复合硬片质量标准的起草说明聚酰胺/铝/聚氯乙烯冷冲压成型固体复合硬片（试行）聚酰胺/铝/聚氯乙烯冷冲压成型固体复合硬片质量标准的起说明聚乙烯/铝/聚乙烯复合药用软膏管（试行）聚乙烯/铝/聚乙烯复合药用软膏管质量标准的起草说明口服固体药用聚酯瓶（试行）口服固体药用聚酯瓶质量标准的起草说明钠钙玻璃药瓶（试行）钠钙玻璃药瓶质量标准的起草说明低硼硅玻璃管制口服液体瓶（试行）低硼硅玻璃管制口服液体瓶质量标准的起草说明硼硅玻璃管制注射剂瓶（试行）硼硅玻璃管制注射剂瓶质量标准的起草说明低硼硅玻璃管制注射剂瓶（试行）低硼硅玻璃管制注射剂瓶质量标准的起草说明 钠钙玻璃模制注射剂瓶（试行）钠钙玻璃模制注射剂瓶质量标准的起草说明硼硅玻璃安瓿（试行）硼硅玻璃安瓿质量标准的起草说明低硼硅玻璃安瓿（试行）低硼硅玻璃安瓿质量标准的起草说明多层共挤输液用膜、袋通则（试行）多层共挤输液用膜、袋通则的起草说明SFDA 药包材标准汇编（第三辑，2003年10月）----药包材检验方法标准汇编细胞毒性检查法热原检查法溶血检查法急性全身毒性检查法皮肤致敏检查法皮内刺激检查法原发性皮肤刺激检查法气体透过量测定法水蒸气透过量测定法剥离强度测定法拉伸性能测定法热合强度测定法密度测定法氯乙烯单体测定法偏二氯乙烯单体测定法内应力测定法耐内压力测定法热冲击和热冲击强度测定法垂直轴偏差测定法平均线热膨胀系数的测定法线热膨胀系数测定法砷、锑、铅浸山量测定法三氧化二硼测定法121℃内表面耐水性测定法和分级玻璃颗粒在121℃耐水性测定法和分级SFDA 药包材标准汇编（第四辑，2003年12月）硼硅玻璃药用管低硼硅玻璃药用管钠钙玻璃药用管硼硅玻璃输液瓶低硼硅玻璃模制药瓶硼硅玻璃模制注射剂瓶低硼硅玻璃模制注射剂瓶钠钙玻璃管制注射剂瓶药用玻璃成份分类及其试验方法低硼硅玻璃管制药瓶钠钙玻璃管制药瓶抗生素瓶用铝塑组合盖口服液瓶撕拉铝盖外用液体药用高密度聚乙烯瓶输液瓶用铝塑组合盖SFDA 药包材标准汇编（第五辑，2005年1月）低硼硅玻璃输液瓶硼硅玻璃管制口服液体瓶钠钙玻璃管制口服液体瓶硼硅玻璃管制药瓶硼硅玻璃模制药瓶预灌封注射器用硼硅玻璃针管预灌封注射器用氯化丁基橡胶活塞预灌封注射器用溴化丁基橡胶活塞预灌封注射器用不锈钢注射针预灌封注射器用聚异戊二烯橡胶针头护帽预灌封注射器组合件（带注射针）笔式注射器用硼硅玻璃珠笔式注射器用硼硅玻璃套筒笔式注射器用铝盖笔式注射器用氯化丁基橡胶活塞和垫片笔式注射器用溴化丁基橡胶活塞和垫片口服固体药用低密度聚乙烯防潮组合瓶盖铝/聚乙烯冷成型固体药用复合硬片双向拉伸聚丙烯/真空镀铝流延聚丙烯药品包装用复合膜、袋玻璃纸/铝/聚乙烯药品包装用复合膜、袋药品包装用铝塑封口垫片通则口服制剂用硅橡胶胶塞、垫片药用合成聚异戊二烯垫片塑料输液容器用聚丙烯组合盖胶囊用明胶包装材料红外光谱测定法包装材料不溶性微粒测定法乙醛测定法加热伸缩率测定法挥发性硫化物测定法包装材料溶剂残留量测定法注射剂用胶塞、垫片穿刺力测定法注射剂用胶塞、垫片穿刺落屑测定法玻璃耐沸腾盐酸浸蚀性的测定法和分级玻璃耐沸腾混合碱水溶液浸蚀性的测定法和分级玻璃颗粒在98℃耐水性测定法和分级砷、锑、铅、镉浸出量测定法抗机械冲击测定法直线度测定法药用陶瓷吸水率测定法药品包装材料生产厂房洁净室（区）的测试方法聚氯乙烯/聚乙烯/聚偏二氯乙烯固体药用复合硬片聚氯乙烯固体药用硬片聚氯乙烯/聚偏二氯乙烯固体药用复合硬片聚氯乙烯/低密度聚乙烯固体药用复合硬片注射液用卤化丁基橡胶塞注射用无菌粉末用卤化丁基橡胶塞标准号页码YBB000120025YBB0002200211YBB0003200216YBB0004200223YBB0005200230YBB0006200237YBB0007200241YBB0008200245YBB0009200249YBB0010200253YBB0011200258YBB0012200262YBB0013200266YBB0014200272767982848790929496981001031041071YBB0015200248YBB001620021016YBB001720021719YBB001820022123YBB001920022527YBB0020200229注册司食药监注函【2005】8号已被YBB00042005及原YBB00052005替代SFDA 注册司食药监注函【2005】35号已被YBB00202005替代YBB002120023844YBB002220024652YBB002320025561YBB002420026368YBB002520027074YBB002620027681YBB002720028388YBB002820029094YBB002920029699YBB00302002101104YBB00312002106109YBB00322002111117YBB00332002119126YBB00342002127133检验方法标准汇编171012151821242935384346已被YBB00222005替代已被YBB00232005替代SFDA注册司食药监注函【2005】8号已被YBB00212005替代5356596266687378828488 YBB002620031 YBB002720037 YBB0028200313 YBB0029200318 YBB0030200327 YBB0031200337 YBB0032200343 YBB0033200349 YBB0034200354 YBB0035200358 YBB0036200363 YBB0037200368 YBB0038200377 YBB0039200384 YBB0040200391YBB000120041 YBB0002200410 YBB0003200416 YBB0004200423 YBB0005200429 YBB0006200438 YBB0007200443 YBB0008200449 YBB0009200455 YBB0010200462 YBB0011200465 YBB0012200472YBB0013200476 YBB0014200481 YBB0015200485 YBB0016200493 YBB00172004101 YBB00182004108 YBB00192004115 YBB00202004121 YBB00212004127 YBB00222004132 YBB00232004136 YBB00242004143 YBB00252004153 YBB00262004157 YBB00272004160 YBB00282004166 YBB00292004170 YBB00302004173 YBB00312004175 YBB00322004179 YBB00332004185 YBB00342004192 YBB00352004197 YBB00362004203 YBB00372004207 YBB00382004211 YBB00392004214 YBB00402004218 YBB00412004221 YBB00202005244YBB00212005248 YBB00222005252 YBB00232005256 YBB00042005260 YBB00052005264′SFDA注册司食药监注函【2005】8号SFDA注册司食药监注函【2005】35号替代原YBB00042002及原YBB00052002替代原YBB00202002替代原YBB00212002替代原YBB00222002替代原YBB00232002注册司【2005】35号。
【2019年整理】药品包装说明书管理规定24号
国家食品药品监督管理局令第24号《药品说明书和标签管理规定》于2006年3月10日经国家食品药品监督管理局局务会审议通过，现予公布，自2006年6月1日起施行。
局长：邵明立二○○六年三月十五日药品说明书和标签管理规定第一章总则第一条为规范药品说明书和标签的管理，根据《中华人民共和国药品管理法》和《中华人民共和国药品管理法实施条例》制定本规定。
第二条在中华人民共和国境内上市销售的药品，其说明书和标签应当符合本规定的要求。
第三条药品说明书和标签由国家食品药品监督管理局予以核准。
药品的标签应当以说明书为依据，其内容不得超出说明书的范围，不得印有暗示疗效、误导使用和不适当宣传产品的文字和标识。
第四条药品包装必须按照规定印有或者贴有标签，不得夹带其他任何介绍或者宣传产品、企业的文字、音像及其他资料。
药品生产企业生产供上市销售的最小包装必须附有说明书。
第五条药品说明书和标签的文字表述应当科学、规范、准确。
非处方药说明书还应当使用容易理解的文字表述，以便患者自行判断、选择和使用。
第六条药品说明书和标签中的文字应当清晰易辨，标识应当清楚醒目，不得有印字脱落或者粘贴不牢等现象，不得以粘贴、剪切、涂改等方式进行修改或者补充。
第七条药品说明书和标签应当使用国家语言文字工作委员会公布的规范化汉字，增加其他文字对照的，应当以汉字表述为准。
第八条出于保护公众健康和指导正确合理用药的目的，药品生产企业可以主动提出在药品说明书或者标签上加注警示语，国家食品药品监督管理局也可以要求药品生产企业在说明书或者标签上加注警示语。
第二章药品说明书第九条药品说明书应当包含药品安全性、有效性的重要科学数据、结论和信息，用以指导安全、合理使用药品。
药品说明书的具体格式、内容和书写要求由国家食品药品监督管理局制定并发布。
第十条药品说明书对疾病名称、药学专业名词、药品名称、临床检验名称和结果的表述，应当采用国家统一颁布或规范的专用词汇，度量衡单位应当符合国家标准的规定。
FDA 行业指南 中英对照 待完成
Guidance for IndustryContainer Closure Systems for Packaging Human Drugs and Biologics Chemistry, Manufacturing and Controls Documentation行业指南人用药品及生物制品的包装容器和封装系统：化学，生产和控制文件指南发布者：美国FDA下属的CDER及CBER发布日期：May 1999TABLE OF CONTENTS目录I.INTRODUCTION介绍II.BACKGROUND 背景A.Definitions 定义B.CGMP, CPSC and USP Requirements on Containers and Closures. CGMP, CPSC和USP对容器和密封的要求C.Additional Considerations 其他需要考虑的事项III.QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS包装组件的合格要求以及质量控制A.Introduction 介绍B.General Considerations 通常要求rmation That Should Be Submitted in Support of an Original Application for Any DrugProduct 为支持任何药品的原始申请所必须提供的信息D.Inhalation Drug Products 吸入性药品E.Drug Products for Injection and Ophthalmic Drug Products 注射剂和眼科用药F.Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems 液体口服和外用药品和外用给药系统G.Solid Oral Dosage Forms and Powders for Reconstitution 口服固体剂型和待重新溶解的粉末H.Other Dosage Forms 其他剂型IV.POSTAPPROVAL PACKAGING CHANGES 批准后的包装变更V.TYPE III DRUG MASTER FILES 药品主文件第III类A.General Comments 总体评述rmation in a Type III DMF 第III类DMF中包括的信息VI.BULK CONTAINERS 大包装容器A.Containers for Bulk Drug Substances 用于原料药的容器B.Containers for Bulk Drug Products 用于散装药品的容器ATTACHMENT A 附件AREGULATORY REQUIREMENTS 药政要求ATTACHMENT B 附件BCOMPLIANCE POLICY GUIDES THAT CONCERN PACKAGING 关于包装，所适用的政策指南ATTACHMENT C 附件CEXTRACTION STUDIES “提取性”研究ATTACHMENT D 附件DABBREVIATIONS 缩略语ATTACHMENT E 附件EREFERENCES 参考文献GUIDANCE FOR INDUSTRY1Container Closure Systems for Packaging Human Drugs and BiologicsChemistry, Manufacturing and Controls DocumentationI．INTRODUCTION介绍This document is intended to provide guidance on general principles2 for submitting information on packaging materials used for human drugs and biologics.3 This guidance supersedes the FDA Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics , issued in February 1987 and the packaging policy statement issued in a letter to industry dated June 30, 1995 from the Office of Generic Drugs.4 This guidance is not intended to describe the information that should be providedabout packaging operations associated with drug product manufacture. 本文件目的是为递交人用药品和生物制品的包装信息提供总体原则指南。
药品包装标签和说明书管理规定（2篇）
药品包装标签和说明书管理规定第一条为加强药品监督管理，规范药品的包装、标签及说明书，以利于药品的运输、贮藏和使用，保证人民用药安全有效，特制定本规定。
第二条药品包装、标签及说明书必须按照国家药品监督管理局规定的要求印制，其文字及图案不得加入任何未经审批同意的内容。
第三条药品包装内不得夹带任何未经批准的介绍或宣传产品、企业的文字、音像及其他资料。
第四条凡在中国境内销售、使用的药品，其包装、标签及说明书所用文字必须以中文为主并使用国家语言文字工作委员会公布的规范化汉字。
第五条药品的通用名称必须用中文显著标示，如同时有商品名称，则通用名称与商品名称用字的比例不得小于1：2，通用名称与商品名称之间应有一定空隙，不得连用。
第六条药品商品名称须经国家药品监督管理局批准后方可在药品包装、标签及说明书上标注。
第七条提供药品信息的标志及文字说明，字迹应清晰易辨，标示清楚醒目，不得有印字脱落或粘贴不牢等现象，并不得用粘贴、剪切的方式进行修改或补充。
第八条药品的包装分内包装与外包装。
(一)内包装系指直接与药品接触的包装(如安瓿、注射剂瓶、铝箔等)。
内包装应能保证药品在生产、运输、贮藏及使用过程中的质量，并便于医疗使用。
药品内包装材料、容器(药包材)的更改，应根据所选用药包材的材质，做稳定性试验，考察药包材与药品的相容性。
(二)外包装系指内包装以外的包装，按由里向外分为中包装和大包装。
外包装应根据药品的特性选用不易破损的包装，以保证药品在运输、贮藏、使用过程中的质量。
第九条药品的标签分为内包装标签与外包装标签。
(一)内包装标签与外包装标签内容不得超出国家药品监督管理局批准的药品说明书所限定的内容;文字表达应与说明书保持一致。
(二)内包装标签可根据其尺寸的大小，尽可能包含药品名称、适应症或者功能主治、用法用量、规格、贮藏、生产日期、生产批号、有效期、生产企业等标示内容，但必须标注药品名称、规格及生产批号。
(三)中包装标签应注明药品名称、主要成分、性状、适应症或者功能主治、用法用量、不良反应、禁忌症、规格、贮藏、生产日期、生产批号、有效期、批准文号、生产企业等内容。
2018年浙江执业药师《药事管理与法规》笔记：标签规范细则
医学考试之家论坛（）2018年浙江执业药师《药事管理与法规》笔记：标签规范细则2018年执业药师考试时间在10月13、14日，考生要好好备考，争取一次性通过考试！小编整理了一些执业药师的重要考点，希望对备考的小伙伴会有所帮助！最后祝愿所有考生都能顺利通过考试！更多精彩资料关注医学考试之家！
药品包装、标签规范细则
1、药品包装、标签上印刷的内容对产品的表述要准确无误，除表述安全、合理用药的用词外，不得印有各种不适当宣传产品的文字和标识，如“国家级新药”、“中药保护品种”、“GMP认证”、“保险公司质量保险”等。
2、药品的商品名须经国家药品监督管理局批准后方可在包装、标签上使用。
未经国家药品监督管理局批准作为商品名使用的注册商标，可印刷在包装标签的左上角或右上角，其字体不得大于通用名的用字。
3、同一企业，同一药品的相同规格品种，其包装、标签的格式及颜色必须一致。
同品种，不同规格的包装、标签应明显区别或标注。
4、包装标签有效期的表达方法，按年月顺序。
如有效期至2001年10月，或表达为有效期至2001.10;2001/10;2001-10等形式。
1至9月份数字前须加0以两位数表示月份。
【药学】药事管理学重点：药品标签和说明书管理
【药学】药事管理学重点: 药品标签和说明书管理抑酸药是抑制胃酸分泌的药物, 通常包括组胺H2受体阻断剂和质子泵抑制剂, 是目前治疗消化性溃疡的更好的选择药。
今天对药学基础知识关于抑酸剂重要知识点进行总结和梳理。
组胺H2受体阻断剂, 目前常用的是西咪替丁、雷尼替丁、法莫替丁、尼扎替丁和罗沙替丁乙酸酯。
在医疗卫生招聘考试中, 药学经常考察药事管理学重点知识, 其中药品标签和说明书, 作为指导患者服药的重要文说明, 是保证患者药物治疗可以取得预期疗效, 以及预判断不良反应的重要依据。
近年来随着医疗纠纷事件的增多, 用药合理性也逐渐成为争论焦点, 同时这一点在事业单位药学招聘考试中逐年递增的趋势也说明了标签和说明书的重要。
药品说明书和标签管理的原则：在中华人民共和国境内上市销售的药品其说明书和标签由国家食品药品监督管理局(SFDA)予以核准。
不得擅自增加或删改原批准内容。
说明书规定：1.药品说明书：内容应当以SFDA核准或获准修改的药品说明书为准, 不得擅自增加和删改原批准的内容。
药品生产企业供上市销售的最小包装必须附有说明书。
在这一点中, 考生需要重点关注法律规定的是最小销售包装, 而不是最小包装, 例如铝纸板包装的最小包装是塑料铝版, 但最小销售包装为盒。
其中每盒必须有说明书, 但每个对于每板只要求有内标签即可。
这是常考的易错点, 需要大家予以重视。
2.药品说明书内容要求：列出全部活性成份、中药药味、辅料;列出全部活性成份或组方中的全部中药药味。
注射剂和非处方药应列出所用的全部辅料名称。
药品处方中含有可能引起严重不良反应成份或者辅料的, 应当予以说明。
在这一点中关键的就是说明书内容一定要全, 关于这一点的记忆, 考生可以参考国内壮阳药添加西地那非的新闻, 这在法律上是不允许的, 但是考生要注意该点与中药保护条例同时参考, 按照保护条例, 为了保护国内秘方, 按照级别不同对于其成分是保密的, 可以不全部列出, 但是这一点在国外就没有用, 所以生活中可以看到云南白药对国内是保密的, 但是在美国则列出了全部成分。
加拿大 药品 包装规格要求 -回复
加拿大药品包装规格要求-回复1.加拿大药品包装规格的起源和背景加拿大药品包装规格的制定是为了确保药品包装的安全性、有效性和一致性，在保护患者健康方面起到了关键作用。
该规定由加拿大药品执照局（Health Canada）制定，并根据《药品和食品法》（Food and Drugs Act）进行执行。
这些规格是一系列法规、准则和标准的组合，涉及药品包装的各个方面。
2.药品包装规格的重要性药品包装规格在保证药品质量和安全性方面起到了关键作用。
合适的包装规格可以保护药品免受外部环境的影响，如光线、湿度和温度。
此外，药品包装还可以提供正确的用药信息，包括剂量、用法和注意事项。
对于需要特殊存储条件的药品，包装规格可以确保其在经销过程中保持恒定的温度和湿度。
3.药品包装规格的种类和要求加拿大药品包装规格要求根据药物的类型、用途和特殊需求而有所不同。
以下是一些常见的药品包装规格要求：-外包装：药品包装要求必须使用抗菌材料，并且允许包装的透明度不得超过特定的要求。
药品的名称、用途、规格、批号和有效期必须清晰可见。
-内包装：内包装通常是密封的，以防止药品受到外部环境的污染。
某些药品可能需要使用具有特殊防护性能的材料，如耐化学品或特殊气体屏障。
-标签：药品包装上的标签必须提供详细的信息，以确保患者正确理解和使用药品。
标签上必须包括药物的通用名称和商标名称、药物的活性成分、规格和剂量、适应症、使用方法和用量、注意事项、不良反应和联系信息等。
-儿童安全性：根据加拿大的法规，儿童易开启包装（child-resistant packaging）是必需的，以防止儿童意外接触到药品。
这种包装要求需要附上一些额外的开启步骤，使年轻儿童很难打开容器。
-特殊要求：某些特殊药物可能有特殊的包装要求，如光敏感药物需要使用光敏感材料进行包装，自封袋用于注射器等。
4.药品包装规格的审批和遵守在加拿大，所有的药品包装规格都需要经过加拿大药品执照局的审查和批准。
《国家食品药品监督管理局药品特别审批程序》(21号令)英文版
Special Review and Approval Procedure for Drug Registration of theState Food and Drug Administration(SFDA Decree No. 21)The Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration, adopted at the executive meeting of the State Food and Drug Administration (SFDA) on November 18, 2005, is hereby promulgated and shall go into effect as of the date of promulgation.Shao MingliCommissioner of SFDANovember 18, 2005Special Review and Approval Procedure for Drug Registration of the State Food andDrug AdministrationChapter 1 General ProvisionsArticle 1This Procedure is formulated for the purpose of effective prevention, timely control and elimination of the hazards of public health emergencies to ensure the health and safety of the public in accordance with the Drug Administration Law of the Pe ople’s Republic of China, Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.Article 2The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.Article 3The State Food and Drug Administration may, according to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:(1) Where the President of the People’s Republic of China declares a state of emergency or the State Council decides that certain areas within a province, autonomous region or municipality directly under the Central Government are in a state of emergency;(2) Where the contingency program for public health emergencies is initiated according to law;(3) Where the drug reserve department or the health administrative department of the State Council proposes a special review and approval for drugs having existing national drug standard;(4) Other circumstances applicable to special review and approval.Article 4The State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drugs for the prevention and treatment of public health emergencies.The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection and sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies.Chapter 2 Application Acceptance and On-site InspectionArticle 5Where the special review and approval procedure for drug registration is initiated, the State Food and Drug Administration is responsible for the acceptance of registration applications for drugs for public health emergencies.Where a drug or a preventive biological product for public health emergencies has not been marketed in China, the applicant shall, before submission of the registration application, provide the State Food and Drug Administration with relevant research and development information.Article 6The applicant shall submit a registration application with relevant technical dossier to the State Food and Drug Administration according to the relevant provisions and requirements on administration of drug registration.The registration application for drug for public health emergencies may be submitted in electronic form.Article 7Before submitting an application for registration, the applicant may provide a feasibility assessment application with general information and relevant explanations. TheState Food and Drug Administration shall only comment on the scientific rationality and feasibility of the drug project, and respond within 24 hours.The response to a feasibility assessment application shall be neither deemed as the review and approval opinion nor legally binding on the review and approval result of a registration application.Article 8The State Food and Drug Administration shall organize an expert group to evaluate and review the registration application for drug for the prevention and treatment of public health emergencies, make a decision within 24 hours on whether or not to accept the application, and notify the applicant.Article 9Where a registration application is accepted, the State Food and Drug Administration shall organize technical review of submitted dossier within 24 hours and at the same time notify the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located to conduct an on-site inspection on drug research and development conditions, and organize sampling and testing of pilot products.The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the on-site inspection result and relevant opinion to the State Food and Drug Administration.Article 10The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize staff from the departments of drug registration, drug safety and inspection, etc. to participate in the on-site inspection.The National Institute for the Control of Pharmaceutical and Biological Products shall be notified to send staff to participate in the on-site inspection and sampling of preventive biological products.Article 11For drugs that have existing national standards for the prevention and treatment of public health emergencies, the State Food and Drug Administration may directly review and approve the drug in accordance with the relevant provisions in Chapter 6 of the Procedure when it deems there is no need for a clinical trial in accordance with law.Article 12With respect to the registration application for a specific vaccine, where only the original virus strain used in the manufacturing is changed while the manufacturing processes or quality specifications are maintained, the State Food and Drug Administration shall make a decision on whether or not to grant the approval within three days after verifying the changed strain used in the manufacturing.Chapter 3 Testing for RegistrationArticle 13After receiving the samples taken by the (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government, the drug testing institution shall immediately organize verification of specifications and laboratory testing on the samples.The drug testing institution shall complete the testing within the time frame for the drug being applied.Article 14For a drug applied first time for marketing, the State Food and Drug Administration may, when necessary, make early involvement by appointing the National Institute for the Control of Pharmaceutical and Biological Products to communicate with the applicant prior to testing for registration so as to timely resolve technical problems which may arise in the process of quality specifications verification and laboratory testing.With respect to preventive biological products used to prevent and control the epidemic of serious infectious diseases, the State Food and Drug Administration may, depending on the situation, allow the testing for registration and the manufacturer’s self-testing to be performed in parallel.Article 15After completion of the specifications verification and laboratory testing on a drug, the drug testing institution shall, within two days, issue its verification opinion and submit it along with the drug test report to the State Food and Drug Administration.Chapter 4 Technical ReviewArticle 16The State Food and Drug Administration shall, within 15 days after acceptance of the registration application for drug for the prevention and treatment in public health emergencies, complete the first round of technical review.Article 17Where the State Food and Drug Administration considers that additional data are needed, it shall immediately inform the applicant of the content and timeline.Where the applicant submits the supplementary data within the specified timeline, the State Food and Drug Administration shall complete the technical review within three days, or, depending on the situations, organize another review meeting within five days, and then complete the review report within two days.Chapter 5 Clinical TrialArticle 18Where the technical review is completed, the State Food and DrugAdministration shall, within three days, complete the administrative examination, make a decision and inform the applicant.Where the State Food and Drug Administration decides to approve a clinical trial, it shall issue a Drug Clinical Trial Approval. Where it decides not to approve, it shall issue a Disapproval Notice with reasons.Article 19Where an applicant obtains a clinical trial approval, it shall conduct the trial strictly following the relevant requirements in the approval document, and comply with the Good Clinical Practice.Article 20Drug clinical trials shall be conducted in institutions legally certified for drug clinical trials. If a clinical trial has to be conducted by an institution not yet certified, a special approval by the State Food and Drug Administration should be obtained.The application for a clinical trial conducted by an institution not yet certified for drug clinical trials may be submitted along with the application for drug registration.Article 21The investigator responsible for a drug clinical trial shall, in accordance with the relevant provisions, timely report adverse events occurred in the process of the clinical trial to the State Food and Drug Administration. If no adverse event occurs, the investigator shall collect relevant information and report to the State Food and Drug Administration monthly.Article 22The State Food and Drug Administration shall, in accordance with law, supervise and inspect the clinical trials of drugs for public health emergencies.Chapter 6 Review, Approval and Monitoring of Drug ProductionArticle 23The applicant shall, after completion of the drug clinical trials, submit the relevant data to the State Food and Drug Administration in accordance with the Provisions for Drug Registration.Article 24The State Food and Drug Administration shall, within 24 hours after receiving data submitted by the applicant, organize technical review, and at the same time notify the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to conduct the on-site inspection on the drug manufacturing conditions, and organize the sampling and testing of pilot products.The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the result and opinion of the on-site inspection to the State Food and Drug Administration.Article 25Any newly-established drug manufacturer or manufacturer with newly-built manufacturing workshops or newly-added dosage forms for production may apply to the State Food and Drug Administration for a certificate of the Good Manufacturing Practice along with the application for drug registration. The State Food and Drug Administration shall, when conducting the drug registration review, immediately carry out an inspection on the Good Manufacturing Practice certification.Article 26The drug testing institution shall, after receiving the samples of three batches taken by the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, immediately arrange the testing.Upon completion of testing, the drug testing institution shall, within two days, complete the test report and submit it to the State Food and Drug Administration.Article 27The State Food and Drug Administration shall carry out technical review in accordance with Chapter 4 of the Procedure, and shall, within three days after the completion of the technical review, complete the administrative examination, make a decision and inform the applicant.Where the State Food and Drug Administration decides to approve the drug, it shall issue the Letter of Approval for Drug Registration, and may grant an approval number for the drug at the same time if the applicant has appropriate manufacturing conditions; if it decides to disapprove the manufacturing, it shall issue a Disapproval Notice with reasons.Article 28Where a drug manufacturer or distributor, or a medical and health institution finds any new or serious adverse drug reaction or cluster adverse reaction relating to a specially approved drug for public health emergencies, it shall immediately report the case to the local (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, the health administrative department at the provincial level and the professional institution for adverse drug reactions monitoring.The professional institution for adverse drug reactions monitoring shall regard drugs specially approved for public health emergencies as critically monitored products, analyze the collected case reports in accordance with the relevant provisions and timely report to the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government and the State Food and Drug Administration.The State Food and Drug Administration shall reinforce the reevaluation of approved drugs for public health emergencies after they are marketed.Chapter 7 Supplementary ProvisionsArticle 29The measures for special review and approval of the medical devices for public health emergencies shall be separately formulated by the State Food and DrugAdministration with reference to the relevant provisions of the Procedure. Article 30The Procedure shall go into effect as of the date of promulgation.。
药品包装标签24号令
国家食品药品监督管理局令第24号《药品说明书和标签管理规定》于2006年3月10日经国家食品药品监督管理局局务会审议通过，现予公布，自2006年6月1日起施行。
局长：邵明立二○○六年三月十五日药品说明书和标签管理规定第一章总则第一条为规范药品说明书和标签的管理，根据《中华人民共和国药品管理法》和《中华人民共和国药品管理法实施条例》制定本规定。
第二条在中华人民共和国境内上市销售的药品，其说明书和标签应当符合本规定的要求。
第三条药品说明书和标签由国家食品药品监督管理局予以核准。
药品的标签应当以说明书为依据，其内容不得超出说明书的范围，不得印有暗示疗效、误导使用和不适当宣传产品的文字和标识。
第四条药品包装必须按照规定印有或者贴有标签，不得夹带其他任何介绍或者宣传产品、企业的文字、音像及其他资料。
药品生产企业生产供上市销售的最小包装必须附有说明书。
第五条药品说明书和标签的文字表述应当科学、规范、准确。
非处方药说明书还应当使用容易理解的文字表述，以便患者自行判断、选择和使用。
第六条药品说明书和标签中的文字应当清晰易辨，标识应当清楚醒目，不得有印字脱落或者粘贴不牢等现象，不得以粘贴、剪切、涂改等方式进行修改或者补充。
第七条药品说明书和标签应当使用国家语言文字工作委员会公布的规范化汉字，增加其他文字对照的，应当以汉字表述为准。
第八条出于保护公众健康和指导正确合理用药的目的，药品生产企业可以主动提出在药品说明书或者标签上加注警示语，国家食品药品监督管理局也可以要求药品生产企业在说明书或者标签上加注警示语。
第二章药品说明书第九条药品说明书应当包含药品安全性、有效性的重要科学数据、结论和信息，用以指导安全、合理使用药品。
药品说明书的具体格式、内容和书写要求由国家食品药品监督管理局制定并发布。
第十条药品说明书对疾病名称、药学专业名词、药品名称、临床检验名称和结果的表述，应当采用国家统一颁布或规范的专用词汇，度量衡单位应当符合国家标准的规定。
美国fda医疗器械体系法规qsr中英文版
美国fda医疗器械体系法规qsr中英⽂版美国FDA 医疗器械体系法规QSR820中⽂版Part 820——质量体系法规——⽬录Subpart A- 总则820.1 范围820.3 定义820.5 质量体系Subpart B –质量体系要求820.20 管理职责820.22 质量审核820.25 ⼈员Subpart C- 设计控制820.30 设计控制Subpart D- ⽂件控制820.40 ⽂件控制Subpart E- 采购控制820.50 采购控制Subpart F- 标识与可追溯性820.60 标识820.65 可追溯性Subpart G - ⽣产和过程控制820.70 ⽣产和过程控制820.72 检验、测量和试验设备820.75 过程确认Subpart H - 验收活动:820.80 进货、过程和成品器械检验820.86 检验状态Subpart I –不合格品820.90 不合格品Subpart J - 纠正和预防措施820.100 纠正和预防措施Subpart K –标识和包装控制820.120 设备标签820.130 设备包装Subpart L –搬运/储存/分销和安装820.140 搬运820.150 贮存820.160 分销820.170 安装Subpart L –记录820.180 记录的通⽤要求820.181 设备主要记录820.184 设备历史记录820.186 质量体系记录820.198 投诉⽂件Subpart M –服务820.200 服务Subpart N –统计技术820.250 统计技术Subpart A——总则Subpart A--General ProvisionsSec.820.1 范围Sec. 820.1 Scope.（a）适⽤性Applicability。
（1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。
药品说明书、标签管理规定的英文翻译
Administrative Regulation for Insert and packaging Labels of drug(SFDA Order No.24)State Food and Drug Administration OrderNo.24“Administrative Regulation for Insert and packaging Labels of Drug” had been evaluated & agreed by the management meeting of SFDA by Mar.10, 2006, and publish here, the same to be implemented since June 1st, 2006.SFDA Director: Shao Ming LiMar. 15, 2006 Administrative Regulation for the Insert and Packaging Labels of DrugSection I General rulesNo.1For standardizing the administration for the insert and packaging labels of drug on the basis of “Drug Administration law of the P. R. of China” and “Regulations for Implementation of the Drug Administration Law of the P. R. of China”.No.2Relevant inserts and packaging labels for all the drugs which are sold in china to be in line with the requirements from present regulation.No.3The Inserts and packaging labels of drugs should be approved by SFDA.The packaging labels of drugs to be drafted as per the insert, their text should not exceed the range of insert, and should not contain the character and mark which suggests the efficacy, mislead uses and unsuitable publicity the product.No.4The label should be printed or stickled on the package for drug as per relevant regulations, and can’t carry any other character, audiovisual, or material for introduction or publication propaganda for product and / or manufacturer.The smallest pack sold in market from the pharmaceutical manufacturer should contain insert.No.5The text expression for drug’s insert and labels should be scientific, standard and accurate.The text expression for the insert for OTC drug should be easy for understanding for the patients whom could be able to self judges, selects and uses.No.6The text of drug’s insert and labels should be clear and easy to be differentiated, the mark should be clear and striking, the appearance with dropping words or unstick etc. should not appear, and can't be modified or supplemented by sticking, cutting or altering.No.7The standard Ch. Character published by State Spoken and Written Language Committee should be used for the insert and labels of drug, the Ch. Character expression will be the criterion when has additional other language for reference.No.8For the purpose of protecting the public health and guiding the drug to be used by a right and rational way, the pharmaceutical manufacturer may raises forwardly to add the warnings on the drug’s insert or labels, SFDA also may require relevant pharmaceutical manufacturer to add the warnings on the insert or labels.Section II Drug’s insertNo.9Drug’s insert should contain the important and scientific data, results and information about the safety and efficacy of drug, so that can be able to guide the safe and rational uses of drug.The detail format, contents and written requirement for drug’s insert are drafted and issued by SFDA.No.10The expression of the disease names, pharmaceutical specialized nouns, drug name, clinical test names and results in the drug’s insert should use the special and standard vocabulary or that one issued by state, and the weights and measures to be in line with the requirements of national standard.No.11All the APIs or crude drugs in the formula to be listed in the drug’s insert. All the excipients for the injection and OTC drugs are also to be listed in the insert.That’s to be indicated if the formula contains the ingredient(s) or excipient(s) which may cause a serious adverse reaction.No.12The pharmaceutical manufacturer should track forwardly the safety and efficacy status of drug post market, and should raise the application in time for the modification of drug’s insert if necessary.According to the monitor results for the adverse reactions of drug and the re-evaluation of drug, SFDA also may require the pharmaceutical manufacturer to modify the drug’s insert. No.13The pharmaceutical manufacturer should inform the modified contents to relevant pharmaceutical business companies, used units and the concerned depts. immediately after the modified insert was approved, and implement the modified insert and labels in time as per the requirements.No.14Drug’s insert should contain enough information of adverse reactions of drug, and indicate the adverse reactions in detail. If the pharmaceutical manufacturer had not modified the insert in time on the basis of the safety and efficacy status of drug post market or didn’t indicate enough the adverse reactions of drug in the insert, the harmful result caused to be borne by relevant manufacturer.No.15The approval date and revised date of drug’s insert to be indicated clearly in the insert.Section III Labels of drugNo.16The labels of drug refer to the contents which are printed or pasted in the package of drug, it divides into internal label or outer label. The internal label refers to that label used for immediate pack, and the outer label refers to that labels used for other packs except internal label.No.17The internal label of drug should contain the contents of generic name, indications or efficacy, strength, dosage and administration of drug, mfg date, batch No. expiry date, manufacturer etc.If the pack size is too small and can’t be able to cover all the contents above, at least, that contents of generic name of drug, strength, batch No., expiry date etc. should be indicated. No.18The outer label of drug should indicate the contents of the generic name of drug, ingredient(s), description, indications or efficacy, strength, dosage and administration, adverse reactions, contraindication, warnings & precautions, storage, mfg date, batch No.permission No., manufacturer etc. If the full contents of indications or efficacy, dosage and administration, adverse reactions, contraindication and warnings & precautions can’t be able to be covered, then the major contents to be indicated and note “that details are exhibited in the insert”.No.19Shipper label should indicate the necessary contents of the generic name of drug, strength, storage, mfg date, batch No., expiry date, permission No., manufacturer etc., also may indicate the package quantity and transport warnings and other mark if necessary.No.20The label for API should indicate the necessary contents of drug name, storage, mfg date, batch No., expiry date, specification No., permission No., manufacturer etc., and also indicate the pack side and the transport warnings.No.21For the same drug with same strength and pack size from the same pharmaceutical manufacturer, the text, format and color of the label to be same, for the different strength or pack size, the label should be clearly different or the strength to be indicated clearly.The same drug from the same pharmaceutical manufacturer which is administered for prescription drug as well as OTC drug, the color for both packages should be clearly distinguished respectively.No.22For the drug which storage has special requirement, the storage to be indicated in a striking place of the label.No.23The expiry date in the label of drug should be labeled as per the sequence of year-month-date, the year is expressed as 4 numerals, the month and the date is expressed as 2 numerals respectively. The detail format is labeled as expiry by “XXXX year XX month” or “expiry by XXXX year XX month XX date”, also may be labeled as “expiry by XXXX.XX.” or “expiry by XXXX/XX/XX” etc. with the numeral or other symbol.The expiry period for preventative biological products should be labeled as per the SFDA approval specification. For the biological products for treatment, the expiry period to be counted since the repackaging date, but for other drugs, that to be counted since mfg. Date.If the expiry period is labeled up to the date, then the expiry date should be the previous date corresponding the year-month-date against the initial date. If the expiry period is labeled up to the month, then the expiry date should be the previous month corresponding the year-month against the initial date.Section IV Use of drug name and registered trademarkNo.24The drug name labeled in the insert and labels should be in line with the nominated principle for drug generic name and brand name which is issued by SFDA, and identical with the approval certificate.No.25The generic name of drug should be notable and outstanding, its font, size and color should be accordant, and in line with the requirements below:(1)For the horizontal label, the generic name of drug should be exhibited within the upperthird area at a marked place.For the standing label, the generic name of drug should be exhibited within the third areaof right at a marked place.(2)The font which is not easy to be identified, i.e. grass hand, seal character can’t beselected, and the font can’t be modified with italic, central emptily, hatching forms etc.(3)The color of font should be black or white, to produce a strong contrast against the tintor dark background.(4)The generic name can’t be written in different rows except the pack size is too small andthe full name can’t be exhibited.No.26The brand name can’t be set in the same row with the generic name, the font and color of brand name is not more extrusive and distinct than the generic name, the area of single font is not more than the half area of the font of generic name.No.27The trademark which is not registered and other drug name which is not approved by SFDA are inhibitive to be used for the insert and labels of drug.The registered trademark which is used for drug label should be printed in the side cornerof drug label, if it contains the character, then the area of single font is not more than thequadrant area of the generic name.Section V Other regulationNo.28For the anaesthetic, psychoactive, medical toxicity drug, radioactive drug and the drug for exterior use and OTC etc. which has special mark issued by state, their inserts and labelsshould print the special mark. The insert and labels which have special requirement will be identified by SFDA.No.29The administrative regulation for the labels of crude Chinese traditional medicine or dry pieces will be drafted by SFDA by supplementary document.No.30The insert and labels of drug which didn’t complied with this regulation to be punished as per relevant requirements Drug Administration law of the P. R. of China.Section VI Supplementary articlesNo.31This regulation will be implemented since June 01, 2006. The SFDA Order No.23 issued by Oct 15, 2000 will be disused synchronously.。
2024年处方管理最新标准与实践英文版
2024年处方管理最新标准与实践英文版Latest Standards and Practices in Prescription Management for 2024Prescription management is a critical aspect of healthcare that ensures patients receive the right medications in the correct doses. As we look towards 2024, it is essential to stay updated on the latest standards and practices in this field to provide the best possible care to patients.One key aspect of prescription management in 2024 is the emphasis on electronic prescribing systems. These systems help streamline the prescription process, reduce errors, and improve communication between healthcare providers. By adopting electronic prescribing systems, healthcare facilities can enhance efficiency and accuracy in prescription management.Another important trend in prescription management for 2024 is the focus on patient education and engagement. Healthcare providers are increasingly recognizing the importance of involving patients in theircare decisions, including medication management. By educating patients about their medications and involving them in the decision-making process, healthcare providers can improve medication adherence and overall health outcomes.Furthermore, 2024 will see a continued emphasis on medication reconciliation practices. Medication reconciliation involves comparing a patient's current medication regimen to any new prescriptions to identify any potential discrepancies or issues. By conducting thorough medication reconciliation, healthcare providers can prevent medication errors and adverse drug reactions, ultimately enhancing patient safety.In addition, personalized medicine is expected to play a more significant role in prescription management in 2024. Personalized medicine involves tailoring treatment plans to individual patients based on their genetic makeup, lifestyle, and other factors. By incorporating personalized medicine into prescription management, healthcare providers can optimize treatment outcomes and minimize adverse effects.Overall, staying informed about the latest standards and practices in prescription management is crucial for healthcare providers in 2024. By adopting electronic prescribing systems, focusing on patient education and engagement, emphasizing medication reconciliation, and incorporating personalized medicine, healthcare facilities can enhance patient care and improve outcomes.。
2024-医药包装
〔二〕商品名 指经国家食品药品监督管理部门批准的特定
企业使用的商品名称。 商品名字体不得大于通用名的用字
通用名 英文名
商品名
四、药品的用法和用量
药品的用药方法与用药 剂量的正确性和准确性 是保障消费者用药安稳、 有效的重要根底，因此 内容既要尽量祥细，又 要有较高的可读性及可 操作性。
二、药品包装上的条形码
〔一〕条形码的含义 条形码也叫条码，由一组规那么排列、宽度
不 同、黑白相间、平行相邻的线条组成，并配 有相对应字符组成的码记，用来表示一定的 信息。
〔二〕条形码的功能
1.自动进行阅读识别
2.能对商品销售的信息进行分类、汇总 和分析
3.可以通过计算机网络及时将销售信息 反响给生产单位
商品 或效劳与他人的商品或效劳相区别，而
使用 在商品及其包装上或效劳标记上的由文
字、 图形、字母、数字、三维标志和颜色组
〔二〕商标的符号表示方法
1.TM---商标符 指己经向商标局登记〔申表注册，但只 是商标初步审定公告〕或持有人声明拥 有权利的商品商标。
2.R----注册符 指经商标局正式核准注册的商标。注册 标记包括 注和 R
H代表化学药品 S代表生物制品
Z代表中药
J代表进口分装药品
七、生产批号
生产批号：是指用于识别“批〞的一组 数
定义
印在或者贴在药品包装上用以 记载药品有关内容的文字、图
画或记号的标示物
是传递药品信息、指导医疗专业人员 和消费者用药选择的重要资料之一
药品标签的分类 内包装标签
外包装标签
二、药品说明书的主要内容
〔一〕药品说明书的根本要求 1.应包含有关药品的安稳性、有效性等
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Provisions for Drug Insert Sheets and Labels(SFDA Decree No.24)The Provisions for Drug Insert Sheets and Labels, adopted at the executive meeting of the State Food and Drug Administration on March 10, 2006, is hereby promulgated and shall go into effect as of June 1, 2006.Shao MingliCommissioner of SFDAMarch 15, 2006Provisions for Drug Insert Sheets and LabelsChapter I General ProvisionsArticle 1The Provisions are enacted with a view to regulating drug insert sheets and labels in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administr ation Law of the People’s Republic of China.Article 2The insert sheets and labels of drugs marketed within the territory of the People’s Republic of China shall meet the requirements of the Provisions.Article 3Drug insert sheets and labels shall be reviewed and approved by the State Food and Drug Administration.A drug shall be labeled on the basis of its insert sheet. The content of the label shall be within the scope of the insert sheet. Any words and marks with implied therapeutic effects, misleading information on usage, or inappropriate promotion of the product shall not be printed.Article 4 A drug label shall be printed on or affixed to the drug package, and no other written words, audio and/or visual materials or other information are attached to introduce or publicize the product or the enterprise.An insert sheet shall be attached to the smallest package provided by the drug manufacturer for marketing.Article 5The wording in drug insert sheets and labels shall be scientific, standardized and accurate. The insert sheet of a non-prescription drug shall be written intelligibly and convenient for patients to judge, choose and use the drug on their own.Article 6In the label or insert sheet, the letters or characters shall be clear and easy to be recognized and the marks shall be clear and distinctive. The label and insert sheet shall have no print faded and shall not be affixed unsteadily. Any addition or modification shall not be made by means of pasting, cutting or altering.Article 7Drug insert sheets and labels shall be written in standardized Chinese characters published by the National Language Commission. The versions in other languages shall comply with the Chinese version.Article 8With the aim to protect public health and direct the rational use of drugs, drug manufacturers may voluntarily apply to add warnings to drug insert sheets or labels. The State Food and Drug Administration may also request drug manufacturers to add warnings to drug insert sheets or labels.Chapter II Drug Insert SheetArticle 9 A drug insert sheet shall include the significant scientific data, conclusions and information concerning drug safety and efficacy in order to direct the safe and rational use of drugs. The specific format, content and writing requirements of drug insert sheet shall be prescribed and issued by the State Food and Drug Administration.Article 10Disease names, pharmaceutical terms, drug names, the names and results of clinical testing in drug insert sheets shall be expressed in professional terms published or standardized by the State. The units of measurement shall conform to the national standards.Article 11All the active ingredients or medicinal ingredients of traditional Chinese medicines in a prescription shall be listed in the insert sheet. For injections and non-prescription drugs, all excipients shall be listed as well.The ingredients or excipients included in a prescription, which may cause severe adverse reaction, shall be specified.Article 12 A drug manufacturer shall trace the safety and efficacy of its marketed drugs. For any modification to the insert sheet, an application shall be submitted timely.The State Food and Drug Administration may also require a drug manufacturer to make modification to the insert sheet on the basis of the results of adverse drug reaction monitoring and drug re-evaluation.Article 13After the modification to the insert sheet is approved, the drug manufacturer shall inform relevant drug distributors, drug users and other departments of the modified content immediately, and use the modified insert sheet and label timely as required.Article 14The insert sheet shall provide full information on adverse drug reaction and indicate the adverse reactions in detail. A drug manufacturer, who fails to timely modify the insert sheet on the basis of the safety and efficacy data of the marketed drug or to fully explain the adverse reaction in the insert sheet, shall be liable for all the consequences arising therefrom.Article 15The approval date and the modification date shall be distinctively shown in the insert sheet.Chapter III Drug LabelsArticle 16Drug labels refer to the information printed or pasted on drug packaging, including inner labels and outer labels. Inner labels refer to those that appear on immediate packaging; outer labels are those on the other packaging outside of inner labels.Article 17The inner label shall bear such drug information as the adopted name in China, indications or functions, strength, dose and usage, production date, batch number, expiry date and manufacturer. If there is no enough space in the package to include all the information mentioned above, the adopted name in China, strength, batch number and expiry date shall be indicated at least.Article 18The outer label of a drug shall indicate such information as the adopted name in China, ingredients, description, indications or functions, strength, dose and usage, adverse reactions, contraindications, precautions, storage, production date, batch number, expiry date, approval number and manufacturer. Where indications or functions, dose and usage, adverse reactions, contraindications and precautions cannot be fully noted, main information plus a “See drug insert sheet for details.” notice shall be indicated.Article 19The label on the package for transportation and storage shall bear at least the adopted name in China, strength, storage, production date, batch number, expiry date, approval number and manufacturer. Other information such as packaging quantity, precautions for transportation or other marks may be included when necessary.Article 20The label for drug substance shall include the adopted name in China, storage, production date, batch number, expiry date, applied specifications, approval number and manufacturer. Other necessary information such as packaging quantity and precautions for transportation shall also be indicated.Article 21Where one drug produced by a manufacturer has the same drug strength and packaging specification, the content, format and color of its labels must be the same. Where one drug produced by a manufacturer has different drug strengths or packaging specifications, its labels shall be clearly distinguished from one another, or its specifications shall be notably marked in the corresponding specification items.Where a drug produced by a manufacturer is administrated as prescription drug and non-prescription drug respectively, their packaging colors shall be distinctly different.Article 22For drugs with special requirements on storage, its requirements shall be marked in the notable place of the label.Article 23The expiry date in the drug label shall appear in the order of year, month and day, with year shown in four digits, month and day in two digits. Its specific format shall be “Valid till XXXX year XX month” or “Valid till XXXX year XX month XX day”. It may be presented with numbers and other symbols as “Valid till XXXX.XX.” or “Valid till XXXX/XX/XX”.For the preventive biological product, the expiry date shall be labeled according to the registration specifications approved by the State Food and Drug Administration. The expiry date of the biological product for therapeutic use shall be counted from the filling date. For other drugs, the expiry date shall be counted from the production date.Where the expiry date is labeled to the day, it shall be marked as one day earlier than the actual expiry date; where the expiry date is labeled to the month, it shall be marked as one month earlier than the actual expiry month.Chapter IV Use of Drug Name and Registered TrademarkArticle 24The drug name in insert sheets and labels shall conform to the nomenclature principles on the adopted name in China and trade name of drug announced by the State Food and Drug Administration, and shall be consistent with those appeared in the approval documents of the drug.Article 25The adopted name in China shall be conspicuous and prominent, and its typeface, size and color shall be consistent, and meet the following requirements:(1) For horizontal labels, the adopted name in China shall appear in a prominent position within the area of the upper one-third of the label; for vertical labels, it shall appear in a prominent position within the area of the right one-third of the label;(2) No such illegible typefaces as cursive characters and seal characters shall be used, and no such format as italics, margining and shading shall be used to modify the typefaces.(3) The font color of the adopted name in China shall be black or white, in sharp contrast to the light-colored or dark-colored background respectively.(4) Writing in separate lines shall be avoided unless limited by the packaging size.Article 26The trade name of a drug shall not be placed in the same line with the adopted name in China; its typeface and color shall be no more conspicuous than that of the adopted name in China, and its font area per character shall be no bigger than half of that of the adopted name in China.Article 27Unregistered trademarks and other drug names unapproved by the State Food and Drug Administration shall not be used in the drug insert sheets and labels.Where a registered trademark is used in a drug label, it shall be printed in a corner of the label. Where a registered trademark contains characters, the font area per character shall be no bigger than a quarter of that of the adopted name in China.Chapter V Other ProvisionsArticle 28For narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive pharmaceuticals, drugs for topical use, non-prescription drugs and other drugs having special marks specified by the State, their special marks shall be printed in the drug insert sheets and labels.Where there are special provisions issued by the State for drug insert sheets and labels, they shall prevail.Article 29The labeling provisions for Chinese crude drugs and prepared slices of Chinese crude drugs shall be formulated separately by the State Food and Drug Administration.Article 30Where drug insert sheets and labels are not in compliance with the Provisions, a punishment shall be imposed in accordance with the relevant provisions of the Drug Administration Law of the People’s Republic of China.Chapter VI Supplementary ProvisionsArticle 31These Provisions shall come into force as of June 1, 2006. the Provisions for Drug Packaging, Labels and Insert Sheets (Provisional) issued by State Food and Drug Administration on October 15, 2005 shall be annulled therefrom.。