药品技术转让注册管理规定及其翻译以及点评

药品技术转让注册管理规定 Administrative Regulations for Technology Transfer Registration of Drugs 第一章总则 Chapter ⅠGeneral Provisions 第一条为促进新药研发成果转化和生产技术合理流动,鼓励产业结构调整和产品结构优化,规范药品技术转让注册行为,保证药品的安全、有效和质量可控,根据《药品注册管理办法》,制定本规定。Article 1 This Regulation is formulated in accordance with the Drug Registration Regulation for the purpose of speeding up the transformation of achievements in new drug development, promoting rational transfer of production technologies, encouraging industrial restructuring, optimizing product mix, regulating the registration of drug technology transfer, and assuring the safety, effectiveness and quality controllability of drugs. 讨论: 对“生产技术合理流动”中的“流动”二字,我的理解就是在不同的企业之 间转让,因此译为transfer。 “产业结构调整”:经济新闻中多译为industrial restructuring。根据 在线词典MBA智库百科上的解释,产业结构是指“各产业的构成及各产业之间的联系和比例关系。……把包括产业的构成、各产业之间的相互关系在内的结构特征概括为产业结构。”由此可见,“产业结构”涉及的是不同的行业,而药品技术转让只涉及医药行业。(或者再往大一点说,涉及化工行业。)个人觉得“鼓励产业结构调整”用词过大过空。“产品结构”:在线词典MBA智库百科上的解释为:“产品结构(Product mix)是指一个企业生产的产品中各类产品的比例关系。如:军用品与民用品,机械产品与电器产品,优质产品与一般产品,技术密集型产品与劳动密集型产品等之间的比例关系。”根据该解释将“产品结构”译为product mix。但根据在线词典Business Dictionary上的定义, product mix是指“Range of associated products which yield larger sales revenue when marketed together than if they are marketed individually or in isolation of others.”而根据网上查到的很多资料,“产品结构”就译为product mix。姑且先这样翻译吧,如果有更精准的或官方的翻译,请不吝赐教。 第二条药品技术转让注册申请的申报、审评、审批和监督管理,适用 本规定。 Article 2 Provisions of this Regulation apply to the application, evaluation, examination, and monitoring of technology transfer for drugs. 讨论: “审评”是指由CDE负责的技术审评,故译为evaluation。 “审批”是指由SFDA负责的行政审批,通常译为approval。但SFDA 最后也可能不批准(这种情况下发给《审批意见通知件》并说明理由), 故仅译为examination。 第三条药品技术转让,是指药品技术的所有者按照本规定的要求,将药品生产技术转让给受让方药品生产企业,由受让方药品生产企业申请 药品注册的过程。 药品技术转让分为新药技术转让和药品生产技术转让。 Article 3 Drug technology transfer refers to the transfer of drug production technology by the owner to the transferee (a drug manufacturer) according to the provisions of this Regulation and the application of drug registration by the transferee. Drug technology transfer is classified into new drug technology transfer and drug production technology transfer. 讨论: “转让方”和“受让方”:在在线词典句酷和网上看到的翻译有licensor 和licensee、assignor和assignee、transferor和transferee。个人觉得还是transferor和transferee最确切。在线词典 legal-explanations.com上对licensor的解释为:“Licensor is the person or legal entity who has got authority to grant legal permission for performing certain acts, conducts, activities etc which are restricted or otherwise controlled as a matter of policy.”本文中用licensor可能使人误解为SFDA(发证机关);在线词典The Free Dictionary上对assignee的解释有两种:“1. A party to which a transfer of property, rights, or interest is made. 2. One appointed to act for another; a deputy or agent.”本文中用assignor和assignee可能使人误解为委托方和受托方(第二种解释)。第二章新药技术转让注册申报的条件 Chapter ⅡConditions for the Application of New Drug Technology Transfer 第四条属于下列情形之一的,可以在新药监测期届满前提出新药技术转让的注册申请: (一)持有《新药证》的; (二)持有《新药证书》并取得药品批准文号的。 对于仅持有《新药证书》、尚未进入新药监测期的制剂或持有《新药证书》的原料药,自《新药证书》核发之日起,应当在按照《药品注册管理办法》附件六相应制剂的注册分类所设立的监测期届满前提出新药技术转让的申请。 Article 4 Registration applications for new drug technology transfer may be submitted prior to the expiration date of the monitoring period of the new drug in any of the following circumstances: (1) Drugs with new drug certificates only; (2) Drugs with new drug certificates and drug approval numbers. For (1) finished products with new drug certificates only and not yet in the monitoring period for new drugs; or (2) APIs with new drug certificates, applications for new drug technology transfer shall be submitted prior to the expiration date of the monitoring period for the corresponding finished products specified in Annex 6 of the Drug Registration Regulation from the issue date of the new drug certificates. 讨论: 翻译时用drug统称药物(包括原料药、制剂和中间体),用API指原料药,用finished product指制剂。其实原料药和制剂也可以分别用drug substance和drug product。(写到这里忽然想到:本规定中没有提及中间体――其实有些中间体也是有批准文号的――原因可能是中间体不发给新药证书、持有批准文号的厂家也较少吧。鉴于获得批准文号的中间体都不发给新药证书,因此如果要转让,只能按照生产技术转让中的第二种情形来(见第九条第二点)。这就大大限制了中间体的转让范围,通俗地说就是只能转让给“自己人”。) “尚未进入新药监测期”:并非不设新药监测期。现在不在监测期内,不代将来没有监测期,因此翻译时不用without monitoring period, 而用not yet in the monitoring period。 关于原料药的新药监测期:根据2007年10月1日起施行的《药品注册管理办法》附件6,除表1-表3规定的情形,其它新药不设监测期。而表1-表3列举的都是制剂,因此可以看出原料药是不设监测期的;另外从设立新药监测期的出发点来说,监测期内的新药重点考察的是质量问题和非预期的不良反应,目的是保障人民群众的用药安全,而原料药要做成制剂才能应用于患者,因此对原料药设立监测期也没有意义。正因为原料药不设监测期,本规定中才会以其相应制剂的新药监测期是否届满作为划分该原料药是新药技术转让还是生产技术转让的节点(详见第九条中的讨论)。 第五条新药技术转让的转让方与受让方应当签订转让合同。 对于仅持有《新药证书》,但未取得药品批准文号的新药技术转让,转让方应当为《新药证书》所有署名单位。 对于持有《新药证书》并取得药品批准文号的新药技术转让,转让方除《新药证书》所有署名单位外,还应当包括持有药品批准文号的药品生产企业。 Article 5 A new drug technology transfer contract shall be signed between the transferor and transferee. For drugs with new drug certificates but without drug approval numbers, the transferor shall be all the holders of the new drug certificates. For drugs with new drug certificates and drug approval numbers, the transferor shall be all the holders of the new drug certificates and the drug approval numbers. 讨论: 开始翻译时将“《新药证书》所有署名单位”理解成了持有《新药证书》的单位,忽略了其中all的意思。检查时发现并纠正。 第六条转让方应当将转让品种的生产工艺和质量等相关技术资料全部转让给受让方,并指导受让方试制出质量合格的连续3个生产批号的样品。 Article 6 The transferor shall transfer all the relevant technical dossier of the transferred product such as the manufacturing process and specifications to the transferee and guide the transferee in trial production of 3 consecutive batches of qualified samples. 讨论: Qualified用于产品,意思是“合格的”;用于人或企业,意思是“有资质的”。 第七条新药技术转让申请,如有提高药品质量,并有利于控制安全性风险的变更,应当按照相关的规定和技术指导原则进行研究,研究资料连同申报资料一并提交。 Article 7 In case changes improving the quality and safety risk control occur in the new drug technology transfer, research shall be conducted in accordance with relevant regulations and technical guidelines. The research information shall be submitted simultaneously with the application dossier. 讨论: “一并提交”:也可以用accompanied by表示。如:“A n application shall be accompanied by declarations made under section 20 (1) or (2), as the case may be.”(申请须连同根据第20 (1)或(2)条所作的声明书一并提交。)但这种情况下应译作The application dossier shall be accompanied by the research materials/ information.考虑到上下文的衔接,在最后一句中还是将research information作为主语。 第八条新药技术转让注册申请获得批准之日起,受让方应当继续完成转让方原药品批准证明文件中载明的有关要求,例如药品不良反应监测和IV期临床试验等后续工作。 Article 8 The transferee shall continue to complete the requirements specified in the original drug approval documents issued to the transferor from the approval date of the new drug technology transfer application, for example, to complete the monitoring of ADRs and phase IV clinical trials. 讨论: “原药品批准证明文件”不光指注册批件,还包括补充申请批件等,所以用approval documents统称。 第三章药品生产技术转让注册申报的条件 Chapter ⅢConditions for the Application of Drug Production Technology Transfer 第九条属于下列情形之一的,可以申请药品生产技术转让: (一)持有《新药证书》或持有《新药证书》并取得药品批准文号,其新药监测期已届满的; 持有《新药证书》或持有《新药证书》并取得药品批准文号的制剂,不设监测期的; 仅持有《新药证书》、尚未进入新药监测期的制剂或持有《新药证书》不设监测期的原料药,自《新药证书》核发之日起,按照《药品注册管理办法》附件六相应制剂的注册分类所设立的监测期已届满的; (二)未取得《新药证书》的品种,转让方与受让方应当均为符合法定条件的药品生产企业,其中一方持有另一方50%以上股权或股份,或者双方均为同一药品生产企业控股50%以上的子公司的; (三)已获得《进口药品注册证》的品种,其生产技术可以由原进口药品注册申请人转让给境内药品生产企业。 Article 9 Drug production technology transfer may be applied in any of the following circumstances: (1) a. Drugs with new drug certificates only or simultaneously with drug approval numbers, the monitoring periods of which have expired; b. Finished products with new drug certificates only or simultaneously with drug approval numbers, but without monitoring periods; c. ①Finished products with new drug certificates only and not yet in the monitoring periods; or ②APIs with new drug certificates, for which the monitoring periods of the corresponding finished products specified in Annex 6 of the Drug Registration Regulation have expired from the issue date of the new drug certificates; (2) For drugs without new drug certificates, both the transferor and transferee shall be legally qualified drug manufacturing enterprises, one of which holding over 50 percent of the equity or shares of the other, or both of which being subsidiaries of a same drug manufacturing enterprise, which is the majority shareholder of both sides. (3) For import drugs with IDLs, the production technology may be transferred to local drug manufacturing enterprises by the original appliers for the import drug registration. 讨论: 第一点讨论的都是有新药证书的制剂(新药监测期已届满、不设新药监 测期、尚未进入新药监测期)和原料药。通过与本规定第四条对照,可以发现对于持有新药证书的制剂或原料药,到底是申请新药技术转让还是申请生产技术转让的划分依据就是新药监测期(对于原料药来说是其相应制剂的新药监测期):(1)在届满之前提出申请的,按新药技术转让走;(2)在届满之后提出申请或本身不设监测期的,按生产技术转让走;(3)对于尚未进入新药监测期的制剂,连新药监测期从何时开始都不知道,自然也就不能确定何时届满,那么这种情况到底适用于新药技术转让还是生产技术转让呢?本人从来没遇到过这种情况,希望大家集思广益,说说自己的看法。 “股权”:根据MBA智库百科上的解释,“股权即股票持有者所具有的与其拥有的股票比例相应的权益及承担一定责任的权力。基于股东地位而可对公司主张的权利,是股权。”根据路透金融词典上的解释,股权即股本,是指“股东在公司中所占的权益,多用于指股票。”由此可见,股权跟股票既有联系又有区别。它侧重于股东的权益和权力,其物化的表现形式是股票。对“股权”的翻译有share right和equity,我们上商务英语课时老师用到的词汇是equity。从网上搜索的结果来看,也是equity用得较多。 “控股”:从CNKI翻译助手上查到的解释:“握有其他公司多数股票以达到控制目的的公司。西方国家所说的控股公司一般只是为了控制其他公司的股份权利,如果公司本身同样经营某种业务则称为混合控股公司或控股-营业公司。建立控股公司是因为可以较少的资本达到与合并、兼并其他企业同样的效果,而且不必承担子公司的债务,但税款往往较 高。”根据路透金融词典上的解释,“控股公司是一家能有效地控制另外一家(或多家)公司的经营管理的公司。有效控制通常是通过持有一家公司的多数股权,行使投票权令董事会为己方人选所控制。”其对应的英文为holding company。 “其中一方持有另一方50%以上股权或股份”:根据以上引用的对控股公司的解释,这种情况可以理解为“其中一方为另一方的控股公司”,因此也可以译为one of which is the holding company of the other。“母公司”:网上搜到的解释:“母公司(Parent Company)指拥有其他公司的股份,从而控制其经营活动,使其成为自己的附属公司的公司。(主要通过控股权、非股权、销售渠道、生产资金的安排)。母公司是本国政府注册的法人团体。从历史上看,母公司的形式与控股权公司的发展相联系的。母公司可分为“纯控股公司”与“混合控股公司”:假如母公司只把握股权或其他有价证券,自己不再从事别的业务活动,而且也不参与被它控制的其他公司的经营治理,这家母公司就叫“控股公司”(Pure Holding Company)。有些国家的法律规定,纯控股公司不得从事工贸易活动,也不得直接参与公众进行交易,除了自己的办公楼外,不得拥有额外的房地产;很多母公司既从事参股和控股活动,又经营工贸易,故称为“混合控股公司”(Mixed Holding Company or Holding-Operating Company)。混合控股的方法不仅盛行于制造业,也进入了金融业。一般说来,跨国经营中的母公司不是纯控股公司,但可以看作是混合控股公司。但母公司参与子公司的经营治理,主要指在方针、战略上的参与,而不是日常业务操纵。”从以上解释来看,母公 司即控股公司。 “双方均为同一药品生产企业控股50%以上的子公司”:根据以上引用的对母公司的解释,这种情况可以理解为“双方的母公司为同一药品生产企业”,因此也可以译为the parent company of which are a same drug manufacturer, holding the majority share of both sides。从上文引用的“控股公司是一家能有效地控制另外一家(或多家)公司的经营管理的公司。有效控制通常是通过持有一家公司的多数股权……”来看,持有50%以上的股份就算控股,但控股未必是通过持有50%以上的股份来实现,因此翻译时不能将句中的“控股50%以上”省略不译。 第十条药品生产技术转让的转让方与受让方应当签订转让合同。 Article 10 A drug production technology transfer contract shall be signed between the transferor and transferee. 第十一条转让方应当将所涉及的药品的处方、生产工艺、 质量标准等全部资料和技术转让给受让方,指导受让方完成 样品试制、规模放大和生产工艺参数验证实施以及批生产等 各项工作,并试制出质量合格的连续3个生产批号的样品。 受让方生产的药品应当与转让方生产的药品质量一致。 Article 11 The transferor shall transfer all the relevant dossier and technologies of the transferred product such as the formula, manufacturing process and specifications to the transferee and guide all the work such as the lab-scale production, the pilot-scale production, the validation of manufacturing process parameters, and batch production. The transferor shall also guide the transferee in the trial production of 3 consecutive batches of qualified samples. Drugs manufactured by the transferee shall be consistent with those produced by the transferor in quality. 讨论: 句中两个“试制”的意思有别。第一处“试制”是指在实验室里进行的小试,故译为lab-scale production,第二处“试制”是指工业规模的大生产,故译为trial production。 “规模放大”:指中试。ICH指导原则中用pilot scale表示中试规模。 第十二条受让方的药品处方、生产工艺、质量标准等应当与转让方一致,不应发生原料药来源、辅料种类、用量和比例,以及生产工艺和工艺参数等影响药品质量的变化。Article 12 Drugs manufactured by the transferee shall be consistent with those produced by the transferor in formula, manufacturing process, specifications and so on. Changes affecting the drug quality such as changes in API, excipients (kind, quantity and proportion), manufacturing process and process parameters shall not occur. 讨论: “原料药来源”:根据附件中的申报资料要求,原料药的合法来源证明文件包括“原料药的批准证明文件、药品标准、检验报告……等的复印件”。因此这里的原料药来源并非仅指原料药生产商(API manufacturer),还包括质量标准(specifications)。有些原料药生产商会销售不同质量等级的原料药(例如供出口用的符合EP或USP,供国内用的符合ChP),其在含量测定、残留溶剂等方面都可能存在差异,最终影响成品的收率、残留溶剂等,因此我在译文中用API来笼统地指代“原料药来源”。当然在实际的转让过程中以上情况很少出现――既然是在国内生产,用符合ChP的原料药就可以了。能符合EP或USP更好,但那样的话原料药的价格也上去了;即便企业想使用质量等级更高的原料药,也可以在转让申请获得批准后再做补充申请。 这一条对同时持有中间体和制剂批准文号的生产企业进行技术转让非常有利,原因大家自己去想吧。 第十三条受让方的生产规模应当与转让方的生产规模相 匹配,受让方生产规模的变化超出转让方原规模十倍或小于 原规模十分之一的,应当重新对生产工艺相关参数进行验 证,验证资料连同申报资料一并提交。 Article 13 The production scale of the transferee shall be not exceeding 10 fold and not less than one-tenth of the production scale of the transferor, otherwise the relevant manufacturing process parameters shall be revalidated and the validation dossier shall be submitted simultaneously with the application dossier. 讨论: “匹配”:在上文中的意思并非“等同”,而是在一定的范围内, 故不用the same with、comply with等等。 “应当重新对生产工艺相关参数进行验证”:当受让方的生产 规模与转让方匹配时,也是要进行验证的。那么“重新”二 字作何解释?难道先按照转让方原生产规模验证一遍,再 按照受让方生产规模验证一遍?这太不现实了。个人感觉 本规定中写这一条只是为了突出生产规模的变化对制剂质 量的潜在影响。 第四章药品技术转让注册申请的申报和审批 Chapter ⅣApplication and Examination of Technology Transfer for Drugs 第十四条药品技术转让的受让方应当为药品生产企业,其受让的品种剂型应当与《药品生产许可证》中载明的生产范围一致。 Article 14 The transferee shall be a drug manufacturing enterprise, the production scope of which specified by the Drug Manufacturing License shall cover the dosage form of the transferred drug. 讨论: 原来的译文:“The transferee shall be a drug manufacturing enterprise and the dosage form of the transferred drug shall be in accordance with the manufacturing scope listed in the Drug Manufacturing License.”因为这里强调的是受让方的资质,所以按照“其《药品生产许可证》中载明的生产范围应涵盖受让品种的剂型”来修改译文。 第十五条药品技术转让时,转让方应当将转让品种所有规格一次性转让给同一个受让方。 Article 15 The transferor shall transfer all the strengths of the transferred drug to a same transferee in one transaction. 讨论: “规格”:经常有人在翻译时将“规格”(strength)和“质量标准” (specifications)搞混。在其它行业中,“规格”有时会用size、specifications等来表示,例如:“If you ship the wrong specifications, complications will arise.”(如果你们装运的规格有误,就会造成混乱。)但对于药品来说,“规格”是指制剂的标示量(例:本品每片含主要成分××0.2克)或中间体的含量(例:1g:0.69g)。(对于原料药来说,仅存在“包装规格”,如50kg/桶,不存在“规格”。)而specifications是指药物的质量标准,包括含量、水分、无机杂质、有关物质、残留溶剂等。CNKI翻译助手和句酷上“规格”一词对应的英文也有specification、standard等等,但细看中英文例句就会发现,句中的“规格”其实就是“标准”的意思。例如:“This last consignment of hosiery is quite up to standard.”(这批新到的针织品完全符合规格。)“He conformed the plans to the new specifications.”(他使自己的设计符合新的规格。)由上可见,同一词汇在不同的行业里会有不同的意思,需要区分清楚。 第十六条麻醉药品、第一类精神药品、第二类精神药品原料药和药品类易制毒化学品不得进行技术转让。 第二类精神药品制剂申请技术转让的,受让方应当取得相应品种的定点生产资格。 放射性药品申请技术转让的,受让方应当取得相应品种的《放射性药品生产许可证》。 Article 16 Technology transfers for APIs of narcotic drugs, psychotropic drugs of category I, psychotropic drugs of category II, and drug precursors are forbidden. Finished products for psychotropic drugs of category II shall only be transferred to manufacturers with the qualification for designated production. Radioactive drugs shall be only transferred to manufacturers with manufacturing licenses for the corresponding drug. 讨论: “药品类易制毒化学品”:参考EU网站内容译为drug precursors。该网站上的解释:"Drug Precursors" are chemical substances frequently used to manufacture illicit drugs such as ecstasy or amphetamines. Having wide legitimate uses, drug precursors may be extremely dangerous when diverted from the licit distribution channels for the illicit manufacturing of drugs. 第十七条申请药品技术转让,应当填写《药品补充申请表》,按照补充申请的程序和规定以及本规定附件的要求向受让方所在地省、自治区、直辖市药品监督管理部门报送有关资料和说明。 对于持有药品批准文号的,应当同时提交持有药品批准文号的药品生产企业提出注销所转让品种药品批准文号的申请。 对于持有《进口药品注册证》、同时持有用于境内分包装的大包装《进口药品注册证》的,应当同时提交转让方注销大包装《进口药品注册证》的申请。已经获得境内分包装批准证明文件的,还要提交境内分包装药 品生产企业提出注销所转让品种境内分包装批准证明文件的申请。 对于已经获准药品委托生产的,应当同时提交药品监督管理部门同意终止委托生产的相关证明性文件。 Article 17 For drug technology transfer, a Supplementary Application Form shall be filled in. The dossier and explanation shall be submitted to the provincial food and drug administration where the transferee is located in accordance with the procedure of supplementary application and the attached requirements of this Regulation. For drugs with drug approval numbers, the application of writing off the original drug approval numbers by the holders shall be submitted simultaneously. For drugs with IDLs of finished products and simultaneously with IDLs of bulk products for local package in China, the application of writing off the IDLs for bulk drugs by the transferor shall be submitted simultaneously. For drugs with approval documents for local package in China, the application of writing off the above approval documents by the local package enterprises shall be submitted simultaneously. For drugs with approval of toll manufacture, relevant approval documents for the termination of toll manufacture issued by food and drug administrations shall be submitted simultaneously. 讨论: “用于境内分包装的大包装”:想不到合适的表达,姑且译为bulk products for local package in China/ within the territory of China。如果有更精准的或官方的翻译,请不吝赐教。 “《进口药品注册证》”:Import Drug License,缩写为IDL。 第十八条对于转让方和受让方位于不同省、自治区、直辖市的,转让方所在地省、自治区、直辖市药品监督管理部门应当提出审核意见。Article 18 In case the transferor and transferee are located in different provinces, autonomous regions or municipalities, the provincial food and drug administration where the transferee is located shall bring forward examination opinions. 讨论: “省、自治区、直辖市”:如果涉及全国各省、自治区或直辖市,可以用“provinces, autonomous regions and municipalities”,但此处只能用“or”,因为转让方不可能以跨省市的形式存在,受让方也如此。 第十九条受让方所在地省、自治区、直辖市药品监督管理部门对药品技术转让的申报资料进行受理审查,组织对受让方药品生产企业进行生产现场检查,药品检验所应当对抽取的3批样品进行检验。 Article 19 The provincial food and drug administration where the transferee is located is responsible for the format examination of the application dossier for technology transfer and the organization of site inspection on the transferee. The institute for food and drug control where the transferee is located is responsible for testing 3 batches of samples. 讨论: “受理审查”:此处指形式审查,以决定是否受理。故译为format examination。 第二十条国家食品药品监督管理局药品审评中心应当对申报药品技术转让的申报资料进行审评,作出技术审评意见,并依据样品生产现场检查报告和样品检验结果,形成综合意见。 Article 20 CDE shall evaluate the application dossier, form a technical evaluation opinion and bring forward a comprehensive evaluation opinion according to the site inspection report and the testing result of the samples. 讨论: “综合意见”:姑且译为comprehensive evaluation opinion。如果有更精准的或官方的翻译,请不吝赐教。 第二十一条国家食品药品监督管理局依据药品审评中心的综合意见,作出审批决定。符合规定的,发给《药品补充申请批件》及药品批准文号。 转让前已取得药品批准文号的,应同时注销转让方原药品批准文号。转让前已取得用于境内分包装的大包装《进口药品注册证》、境内分包装批准证明文件的,应同时注销大包装《进口药品注册证》、境内分包装批准证明文件。 第二类精神药品制剂的技术转让获得批准后,转让方已经获得的该品种定点生产资格应当同时予以注销。 新药技术转让注册申请获得批准的,应当在《新药证书》原件上标注已批准技术转让的相关信息后予以返还;未获批准的,《新药证书》原件予以退还。 对于持有《进口药品注册证》进行技术转让获得批准的,应当在《进口药品注册证》原件上标注已批准技术转让的相关信息后予以返还。 需要进行临床试验的,发给《药物临床试验批件》;不符合规定的,发给《审批意见通知件》,并说明理由。 Article 21 SFDA shall determine whether to approve the application according to the comprehensive evaluation opinion brought forward by CDE. The Approval Letter of Supplementary Application and a drug approval number will be issued for qualified application. For drugs having obtained drug approval numbers before the technical transfer, the original drug approval numbers issued to the transferor shall be written off simultaneously. For drugs having obtained IDLs of bulk drugs for local package in China and the approval documents for local package in China before the transfer, the above certificates and approval documents shall be written off simultaneously. For finished products for psychotropic drugs of category II, the qualification for designated production priorly obtained by the transferor shall be written off at the time of approval of the technology transfer. In case the new drug technology transfer is approved, the original copy of the new drug certificate shall be returned with added information of the transfer. Otherwise the original copy of the new drug certificate shall be sent back. In case the technology transfer for drugs with IDLs is approved, the original copy of the IDL shall be returned with added information of the transfer. An Approval Letter for Clinical Trials is issued when necessary. For unqualified application, a Notification Letter of the Examination Opinions is issued and the reason for rejection is explained. 讨论: “境内分包装批准证明文件”:没有做过境内分包装的申请,不知都有哪些证明文件? “在《新药证书》原件上标注已批准技术转让的相关信息后予以返还”: 原来的译文是the original copy of the new drug certificate shall be marked with the relevant information of the transfer and returned,后来觉得不够简洁,故改为the original copy of the new drug certificate shall be returned with added information of the transfer。 第二十二条经审评需要进行临床试验的,其对照药品应当为转让方药品生产企业原有生产的、已上市销售的产品。转让方仅获得《新药证书》的,对照药品的选择应当按照《药品注册管理办法》的规定及有关技术指导原则执行。 Article 22 In case clinical trials are necessary deemed by CDE, the reference drug shall be the marketed products manufactured by the transferor. In case the transferor did not obtain a drug approval number, the reference drug shall be selected in accordance with the Drug Registration Regulation and relevant technical guidelines. 讨论: “经审评需要进行临床试验的”:这里的“审评”应该是指CDE的技术审评。 对于到底在什么情况下需要进行临床试验,无从知晓。 第二句是针对研究机构进行的技术转让(只有新药证书、没有批准文号);第一句是针对企业进行的技术转让(同时持有新药证书和批准文 号)。在这种情况下,“其对照药品应当为转让方药品生产企业原有生产的、已上市销售的产品。”这是否意味着企业只有在产品上市后才能将其转让?如果企业由于自身原因无法生产或不想生产(比如原料药供应商断货、市场策略改变等),是否就无法完成技术转让?当然这种情况在现实中非常少――既然费了半天劲获得了新药证书,不生产销售就转让给别人似乎太对不起自己,有点“为他人作嫁衣裳”的感觉――但也不能说完全没有。法规的制订本来就应该考虑到各种极小概率事件。另外,如果企业在获得新药证书和批准文号之后、产品上市之前被兼并、收购或重组――在经济全球化的大趋势下,这种情况今后会越来越多――那么该企业和新公司之间的技术转让又该如何进行呢? 第二十三条完成临床试验后,受让方应当将临床试验资料报送国家食品药品监督管理局药品审评中心,同时报送所在地省、自治区、直辖市药品监督管理部门。省、自治区、直辖市药品监督管理部门应当组织对临床试验进行现场核查。 Article 23 After clinical trials are finished, the transferee shall submit the dossier for clinical trials to CDE and copy to the provincial food and drug administration, which shall organize site inspection on the clinical trials. 第二十四条具有下列情形之一的,其药品技术转让注册申请不予受理,已经受理的不予批准: (一)转让方或受让方相关合法登记失效,不能独立承担民事责任的; (二)转让方和受让方不能提供有效批准证明文件的; (三)在国家中药品种保护期内的; (四)申报资料中,转让方名称等相关信息与《新药证书》或者药品批准文号持有者不一致,且不能提供相关批准证明文件的; (五)转让方未按照药品批准证明文件等载明的有关要求,在规定时间内完成相关工作的; (六)经国家食品药品监督管理局确认存在安全性问题的药品; (七)国家食品药品监督管理局认为不予受理或者不予批准的其他情形。 Article 24 The application for technology transfer shall not be considered or rejected after consideration in any of the following circumstances: (1) The transferor or transferee is unable to bear civil liability independently due to invalidation of the relevant legal registration documents; (2) The transferor or transferee is unable to provide valid approval documents; (3) The drug is in the state TCM protection period; (4) Relevant information in the application dossier such as the name of the transferor is not in accordance with that of the holder of the new drug certificate or the drug approval number, for which the relevant approval documents are missing; (5) The transferor failed to complete the requirements specified in the approval documents in the prescribed time limit; (6) SFDA confirms that there are safety problems with the drugs to be transferred; (7) Other circumstances in which the SFDA determines not to consider or to approve. 讨论: “国家中药品种保护期”:姑且译为state TCM protection period。如果有更精准的或官方的翻译,请不吝赐教。 “申报资料中,转让方名称等相关信息与《新药证书》或者药品批准文号持有者不一致,且不能提供相关批准证明文件的”:原来的译文是and the relevant approval documents are missing,后来觉得将and 改为for which更能体现其中的逻辑关系。因为这里的“相关批准证明文件”是针对“不一致”的情况而讲的。 第五章附则 Chapter ⅤSupplementary Provisions 第二十五条药品技术转让产生纠纷的,应当由转让方和受让方自行协商解决或通过人民法院的司法途径解决。 Article 25 Any dispute occurring in the technology transfer shall be settled by consent or through legal proceedings. 第二十六条本规定自发布之日起施行,原药品技术转让的有关规定同时废止。 Article 26 This Regulation is in effect from the date of issue and other regulations on technology transfer for drugs priorly issued shall be repealed simultaneously.