FDA DMF eCTD

FDA DMF eCTD
FDA DMF eCTD

https://www.360docs.net/doc/ba17925804.html,

FDA DMF eCTD格式

2018年5月5日起,美国食品药品管理局(FDA)将会要求所有的企业以电子通用技术文档(eCTD)格式向FDA递交所有新的药物管理档案(DMF)资料,包括年度报告和修正文档。FDA表明,自该日期起其将会拒收所有非eCTD格式的DMF申请资料。

What is eCTD? 何为eCTD?

eCTD是FDA目前标准化的申请格式。新药申请(NDAs),新药临床试验申请(INDs),简略新药申请(ANDAs),以及某些生物制剂许可申请(BLAs)均需以该格式向FDA 递交。FDA表示,根据《联邦食品、药品及化妆品(FD&C) 法案》的要求,DMF 通常是为了支撑前述申请的目的而递交的,因此,DMF也理应要通过eCTD格式来递交。

自上述日期起,FDA将会要求用户通过FDA《数据标准目录》支持的eCTD格式来递交所有的DMF。此外,在FDA 2017年4月份发布的一份指南中也确立了相关的技术规格,例如文档结构,文件格式及版本,同时还要求用户提供数据集的定位及研究信息。

之前以非CTD格式,包括纸质格式递交的DMF备案无需以eCTD的方式重新递交。但是后续若要对这些DMF递交任何的资料,如年度报告、补充报告以及修改资料等都必须以eCTD格式通过ESG通道递交。若企业选择自愿将其目前的纸质DMF转换为eCTD格式,那么DMF号码会保持不变。选择将其纸质DMF转换为eCTD格式的企业主要是为了加快引用其DMF的NDA或者ANDA的审核速度。

我该如何递交eCTD格式的DMF文档?

不超过10GB的eCTD文档必须通过FDA的电子递交通道(ESG)来递交。在使用ESG系统之前,用户必须向FDA申请一个编码,注册一个ESG账户,并且将其电脑设置为ESG系统使用的语言。FDA建议用户在真正递交之前先多测试几遍。用户可能需要花上数周才能成功登录ESG系统。

或者,您也可以选择一个专业的法规专家,如Registrar Corp来协助贵司更加便捷快速地完成上述操作。Registrar Corp可以协助贵司将DMF转换成eCTD格式并且快速地通过FDA的ESG系统递交贵司的DMF。想要了解更多FDA关于DMF 的eCTD方面的相关要求,您可以通过登录https://www.360docs.net/doc/ba17925804.html,/livehelp与我们全天候在线的法规专员实时联络!

各种证书样本

(1)国际贸易促进委员会产地证明书 统一由贸促总会印刷和编号交各口岸贸促分会管理,各贸促会盖章签字后售给使用单位,由使用单位自行填写,但文字如有更改必须由贸促分会加盖正章。 中国国际贸易促进委员会 China Council for the Promotion of International Trade 原产地证明书 (8)CERTIFICATE OF ORIGIN (1)NO. 06 ?/FONT>074700 (2)日期1987年12月22日 兹证明下列货物的原产地为中华人民共和国 (3)This is to certify that the origin of the under-mentioned goods is the People’s Republic of China 标记及号码 Mark & No.品名 Commodity数量 Quantity重量 Weight (5) A. &. S. No. 62(4) (7)盖章或签字处 Stamp or Signature (2)品质检验证书 检验证书是出口商品的质和量,经过公证机关或生产部门检验后所出具的证明文件。 中华人民共和国上海进出口商品检验局 SHANGHAI IMPORT & EXPORT COMMODITY INSPECTION BUREAU OF THE PEOPLE’S REPUBLIC OF CHINA 检验证书 No. 3051164 INSPECTION CERTIFICATE QUSLITY 地址:上海中山东路一路13号 日期Dec. 6, 1985 Address: 13. Zhongshan Road Date_______________ (E. 1).Shanghai 电报:上海2914 Cable: 2914 SHANGHAI 电话:215529 Tel: 215529 发货人:China National Textiles Imp. & Exp. Corp., Shanghai Branch

原产地证 附样本

原产地证 C/O为CERTIFICATE OF ORIGIN的简称,意思为“原产地证书”,以下为具体内容。 一、原产地证书的作用 原产地证明书(CERTIFICATE OF ORIGIN)是出口商应进口商要求而提供的、由公证机构或政府或出口商出具的证明货物原产地或制造地的一种证明文件。原产地证书是贸易关系人交接货物、结算货款、索赔理赔、进口国通关验收、征收关税在有效凭证,它还是出口国享受配额待遇、进口国对不同出口国实行不同贸易政策的凭证。 二、原产地证书的类型 根据签发者不同,原产地证书一般可分为以下三类: ①商检机构出具的原产地证书, 如:中华人民共和国检验检疫局(CIQ)出具的普惠制产地证格式A(GSP FORM A);一般原产地证书(CERTIFICATE OF ORIGIN)。 ②商会出具的产地证书, 如:中国国际贸易促进委员会(CCPIT)出具的一般原产地证书,简称贸促会产地证书(CCPIT CEERTIFICATE OF ORIGIN); ③制造商或出口商出具的产地证书; 在国际贸易实务中,应该提供哪种产地证明书,主要依据合同或信用证的要求。一般对于实行普惠制国家出口货物,都要求出具普惠制产地证明书。如果信用证并未明确规定产地证书的出具者,那么银行应该接受任何一种产地证明书。现在我国多数出口商习惯于使用贸促会出具的证书。 三、原产地证书的申请 根据我国的规定,企业最迟于货物报关出运前三天向签证机构申请办理原产地证书,并严格按照签证机构的要求,真实、完整、正确地填写以下材料: ①《中华人民共和国出口货物原产地证书/加工装配证明书申请书》; (见附页)此处显示一份《一般原产地证明书/加工装配证明书》图5-1(国际商务单证103) ②《中华人民共和国出口货物原产地证明书》一式四份; ③出口货物商业发票;

原产地证书格式(中英)

附表2 原产地证书格式 * A Certificate of Origin under China-Chile Free Trade Agreement shall be valid for one year from the date of issue in the exporting country. 4

Overleaf Instruction Box 1:State the full legal name, address (including country) of the exporter. Box 2: State the full legal name, address (including country) of the producer. If more than one producer’s good is included in the certificate, list the additional producers, including name, address (including country). If the exporter or the producer wishes the information to be confidential, it is acceptable to state “Available to the competent governmental authority upon request”. If the producer and the exporter are the same, please complete field with “SAME”. If the producer is unknown, it is acceptable to state "UNKNOWN". Box 3: State the full legal name, address (including country) of the consignee. Box 4: Complete the means of transport and route and specify the departure date, transport vehicle No., port of loading and discharge. Box 5: The customs authorities of the importing country must indicate (√) in the relevant boxes whether or not preferential tariff treatment is accorded. Box 6: Customer’s Order Number, Letter of Credit Number, and etc. may be included if required. If the invoice is issued by a non-Party operator, the name, address of the producer in the originating Party shall be stated herein. Box 7: State the item number, and item number should not exceed 20. Box 8: State the shipping marks and numbers on the packages. Box 9: Number and kind of package shall be specified. Provide a full description of each good. The description should be sufficiently detailed to enable the products to be identified by the Customs Officers examining them and relate it to the invoice description and to the HS description of the good. If goods are not packed, state “in bulk”. When the description of the goods is finished, add “***” (three stars) or “ \ ” (finishing slash). Box 10: For each good described in Box 9, identify the HS tariff classification to six digits. Box 11: If the goods qualify under the Rules of Origin, the exporter must indicate in Box 11 of this form the origin criteria on the basis of which he claims that his goods qualify for preferential tariff treatment, in the manner shown in the following table: Insert in Box 11 The origin criteria on the basis of which the exporter claims that his goods qualify for preferential tariff treatment Goods wholly obtained P General rule as ≥ 40% regional value content RVC Products specific rules PSR Box 12: Gross weight in Kilos should be shown here. Other units of measurement e.g. volume or number of items which would indicate exact quantities may be used when customary. Box 13: Invoice number, date of invoices and invoiced value should be shown here. Box 14: The field must be completed, signed and dated by the exporter. Insert the place, date of signature. Box 15: The field must be completed, signed, dated and stamped by the authorized person of the certifying authority. The telephone number, fax and address of the certifying authority shall be given. 5

原产地证明书样本(完整版)

原产地证明书样本 原产地证明书样本。 sampleertifiateoforigin asia-paifitradeagreement 1.goodsonsignedfrom: refereneno. issuedin……………. goodsonsignedto: 3.foroffiialuse 4.meansoftransportandroute: 5.tariffitemnumber: 6.marksandnumberofpakages: 7.number andkindofpakages desription ofgoods: 8.origin riterion 9.gross eight orother quantit:

10.numberanddateofinvoies: 1 1.delarationbtheexporter: theundersignedherebdelaresthattheabovedetailsandstatement sareorret:thatallthegoodsereproduedin ………………………………. andthatthepliththeoriginrequirementsspeifiedforthesegoods intheasia-paifitradeagreementforgoodsexportedto ………………………………. ………………………………. plaeanddate,signatureofauthorized signator1 ertifiate itisherebertifiedonthebasisofontrolarriedout,thatthedelar ationbtheexporterisorret. ………………………………… plaeanddate,signatureandstampof ertifingauthorit notesforpletingertifiateoforigin i.generalonditions: toqualifforpreferene,produtsmust: a)fallithinadesriptionofprodutseligibleforprefereneinthel istofonessionsofanasia-paifitradeagreementountrofdestination;

各类原产地证证书填制规范

普惠制原产地证书格式 A (FORM A)填制规范 普惠制原产地证书采用联合国贸发会统一规定的证书格式,一正二副。正 本为绿色,印有扭索图案底纹,第一副本为白色,第二副本为黄色。证书用英 文或法文填制,证书共有12栏,各栏填制要求如下: 标题栏(右上角),填上检验检疫机构编定的证书号。在证书横线上方填上 “中华人民共和国”。国名必须填打英文全称,不得简化。 Issued in THE PEOPLE'S REPUBLIC OF CHINA (国内证书已将此印上,无需再填打。) 第1栏:出口商名称、地址、国家 此栏带有强制性,应填明详细地址,包括街道名、门牌号码等。例: ZHEJIANG TEXTILES IMPORT AND EXPORT GROUP CO., LTD. NO.165 ZHONGHE ZHONG ROAD, HANGZHOU, CHINA (杭中国地名的英文译音应采用汉语拼音。如ZHEJIANG(浙江)、HANGZHOU (温州)等等。 州)、WENZHOU 第2栏:收货人的名称、地址、国家 此栏应填给惠国最终收货人名称(即信用证上规定的提单通知人或特别声明的 收货人),如最终收货人不明确,可填发票抬头人。但不可填中间转口商的名称。 欧盟、挪威、瑞士对此栏非强制性要求,如果货物直接运往上述给惠国, 且进口商要求将此栏留空,则可不填详细地址,但须填:TO ORDER。 第3栏:运输方式及路线(就所知而言) 一般应填装货、到货地点(始运港、目的港)及运输方式(如海运、陆运、空运),该栏还要填明预定自中国出口的日期,例: ON/AFTER JUN.26, 2012 FROM HANGZHOU TO LONDON, U.K. BY AIR. 转运商品应加上转运港,例ON/AFTER JUN.26,2013 FROM SHANGHAI, CHINA BY SEA V IA HONG KONG, THEN IN TRANSIT TO S WITZERLAND. TO H AMBURG, GERMANY 第4栏:供官方使用(官方声明) 此栏由签证当局填写,正常情况下此栏空白。特殊情况下,签证当局在此 栏加注,如:(1)货物已出口,签证日期迟于出货日期,签发“补发”证书时,

原产地证明样本

原产地证明样本 SAMPLE CERTIFICATE OF ORIGIN Asia-Pacific Trade Agreement (Combined declaration and certificate) consigned from: (Exporter’s businename, address, country) Reference No. Issued in ……………. (Country) 2. Goods consigned to: (Consignee’s name, address, country) Official use 4. Means of transport and route: item number:6. Marks and number of Packages: 7. Number and kind of packages/ description of goods: 8. Origin criterion (see notes overleaf)9. Gross

weight or other quantity:10. Number and date of invoices: 11. Declaration by the exporter : The undersigned hereby declares that the above details and statements are correct: that all the goods were produced in ………………………………. (Country) and that they comply with the origin requirements specified for these goods in the Asia-Pacific Trade Agreement for goods exported to ………………………………. (Importing Country) ………………………………. Place and date, signature of authorized Signatory 12. Certificate It is hereby certified on the basis of control carried out, that the declaration by the exporter is correct. ………………………………… Place and date, signature and Stamp of

原产地证明书样本

原产地证明书样本 SAMPLE CERTIFICATE OF ORIGIN Asia-Pacific Trade Agreement (Combined declaration and certificate) consigned from: (Exporter’s businename, address, country) Reference No. Issued in ……………. (Country) 2. Goods consigned to: (Consignee’s name, address, country) Official use 4. Means of transport and route: item number:6. Marks and number of Packages: 7. Number and kind of packages/ description of goods: 8. Origin criterion (see notes overleaf)9. Gross

weight or other quantity:10. Number and date of invoices: 11. Declaration by the exporter : The undersigned hereby declares that the above details and statements are correct: that all the goods were produced in ………………………………. (Country) and that they comply with the origin requirements specified for these goods in the Asia-Pacific Trade Agreement for goods exported to ………………………………. (Importing Country) ………………………………. Place and date, signature of authorized Signatory 12. Certificate It is hereby certified on the basis of control carried out, that the declaration by the exporter is correct. ………………………………… Place and date, signature and Stamp of

原产地证明书模板(完整版)

原产地证明书模板 原产地证明书模板 第一篇: 原产地证明书模板 原产地证明书模板 来了四个月了,没有接到一个单子,老板忙着接单子、出货,忙 的一团糟,心情不好,我们跟着后面心情不好。终于办公室的单证姐 姐也走了,老板忙啊,以后单证就让你们做了,反正你们以后都是要 做的,现在先学学怎么做的。 没有接到单子,心理本来就是不好受,讲话都没有底气,终于有 事做了,恩,就当是学习了,以前在学校的时候学的是理论,但是和 实地操作还是有差距的。终于,有机会让我来上场了,哈哈哈。 有两票是到叙利亚的,需要做原产地认证和发票认证,先前发票 认证可从来没有听说过埃不知道是啥玩意,只有听老板说是怎么回事了,最后也还是没明白老板说的是啥,硬着头皮先做原产地认证了, 网上申报,是由同事完成的,我只扫了两眼,但是还是需要我和同事 去跑了,唉,原产地认证是做好了,eas。发票认证让我一个人去了,去之前老板和我说,发票金额和报关金额不一样,你和他们说说好 话,让他们帮忙办一下。我也不知道是啥回事,就跑贸促会去了,把 东西拿给办认证的同志,说了很多客气的话,那个同志说发票金额和 报关金额不一致,不行,必须要一致,要么改单价要么改重量。没办法,跑回来了,临走时,还是不忘说一些客气话。屁颠屁颠的回到办 公室了,老板说不行,不能改,单价和重量怎么能改呢!!!非常肯定!!!

我很无语,人贸促会的人是这么说的,就是不给办,怎么搞!!!然后老板无语了,你和他们说说好话,让他们给办一下,我无语,过了一会子,过来一句,你配一下,把金额配好了。就这样,我就灰头土脸的跑回来配啊配,怎么配都是差0.00几美元,我神奇般地发现,只要改一下重量,一切就ok了,哈哈哈,老板一眼,又忙她的去了,过了一会子,恩,就这样吧。我在网上改啊改,终于又是硬着头皮,去了贸促会,结果网上没有改好,后来又不知道是啥问题,现在都忘了原因,又跑了第三趟,终于第四趟发票认证弄好了,第五趟,去拿认证好的发票了。一个发票认证和原产地认证,跑了五趟。 更奇妙的事情还是来了,第二次叙利亚发票认证。有了第一次的经验以后,我信心十足,单据都做好了以后,老板说小羊你已经出师了,当时心里高兴啊,结果跑贸促会了以后,原产地认证就碰钉子了,“先前做的原产地证书呢“?”啊?我们已经寄给客户了氨“那怎么行,要重新做原产地认证,必须拿旧证换新证”,“一票货物只能做一次认证”,赶紧打电话问老板是怎么回事啊,老板也不知道是咋了,只有灰溜溜的回来了,老板还郁闷了呢,怎么还是没有搞定。弄了半天,还是发票号的问题,原来发票号是不一样的,所以做了两次认证,当时在网上申报的时候,我和同事问了老板好几次,是不是上次的发票号,老板嗯嗯嗯的是,这会子不对了,在电话里面的讲话的口气真是来势凶猛,让我避而不及,当时感觉很委屈啊,和同事说了,外面将近40度,我在外面跑,两胳膊晒的黑黑的,结果招来这样的训斥。我招谁惹谁了我,当时心里郁闷埃老板就是老板埃第二天,我屁颠屁颠的弄好了发票,重新申报了,弄好了单据,结果把公司的章盖错地方了,盖到了贸促会的盖章的地方了,当时明

亚太贸易协定原产地证书样本

附表 SAMPLE CERTIFICATE OF ORIGIN Asia-Pacific Trade Agreement 1

Notes for completing Certificate of Origin I. General Conditions: To qualify for preference, products must: a)fall within a description of products eligible for preference in the list of concessions of an Asia-Pacific Trade Agreement country of destination; b)comply with Asia-Pacific Trade Agreement rules of origin. Each article in a consignment must qualify separately in its own right; and c)comply with the consignment conditions specified by the Asia-Pacific Trade Agreement rules of origin. In general, products must be consigned directly within the meaning of Rule 5 hereof from the country of exportation to the country of destination. II. Entries to be made in the boxes Box 1 Goods Consigned from Type the name, address and country of the exporter. The name must be the same as the exporter described in the invoice. Box 2 Goods Consigned to Type the name, address and country of the importer. The name must be the same as the importer described in the invoice. For third party tra de, the words “To Order” may be typed. Box 3 For Official Use Reserved for use by certifying authority. Box 4 Means of Transport and Route State in detail the means of transport and route for the products exported. If the L/C terms etc. do not require such details, type “By Air” or “By Sea”. If the products are transported through a third country this can be indicated as follows: e.g. “By Air”“Laos to India via Bangkok” Box 5 Tariff Item Number Type the 4-digit HS heading of the individual items. Box 6 Marks and Numbers of Packages Type the marks and numbers of the packages covered by the Certificate. This information should be identical to the marks and numbers on the packages. Box 7 Number and Kind of Packages; Description of Goods Type clearly the description of the products exported. This should be identical to the description of the products contained in the invoice. An accurate description will help the Customs Authority of the country of destination to clear the products quickly. Box 8 Origin Criterion Preference products must be wholly produced or obtained in the exporting Participating State in accordance with Rule 2 of the Asia-Pacific Trade Agreement Rules of Origin, or where not wholly produced or obtained in the exporting Participating State must be eligible under Rule 3 or Rule 4. a)Products wholly produced or obtained: enter the letter “A” in Box 8. b)Products not wholly produced or obtained: the entry in Box 8 should be as follows: 1.Enter letter “B” in Box 8, for products which m eet the origin criteria according to Rule 3. Entry of letter “B” would be followed by the sum of the value of materials, parts or produce originating from non-Participating States, or undetermined origin used, expressed as a percentage of the f.o.b. value of the products; (example “B” 50 per cent); 2.Enter letter “C” in Box 8 for products which meet the origin criteria according to Rule 4. Entry of letter “C” would be followed by the sum of the aggregate content originating in the territory of the exporting Participating State expressed as a percentage of the f.o.b. value of the exported product; (example “C” 60 per cent); 3.Enter letter “D” in Box 8 for products which meet the special origin criteria according to Rule 10. Box 9 Gross Weight or Other Quantity Type the gross weight or other quantity (such as pieces, kg) of the products covered by the Certificate. Box 10 Number and Date of Invoices State number and date of the invoice in question. The date of the invoice attached to the Application should not be later than the date of approval on the Certificate. Box 11 Declaration by the Exporter The term “Exporter” refers to the shipper who can either be a trader or a manufacturer. Type the name of the producing country and the importing country and the place and date when the declaration is made. This box must be signed by the Company’s authorized signatory. Box 12 Certification 2

美国原产地证明书

美国原产地证明书 篇一:原产地证明种类 原产地证明种类 FORMA:GENERALIZEDSYSTEMOFPREFERENCESCERTIFICATEOFORIGIN (COMBINEDDECLARATIONANDCERTIFICATE)FORMA 它是受惠国出具的产地证。 4.厂商自己出具的产地证。 由谁出具普通产地证要根据信用证要求办理。必须是经过检验检疫机构培训,并通过考试取得申领员资格证者。各单位凭申领员证到出入境检验检疫局办理产地证书业务,特殊情况下,可凭单位介绍信办理。 2.申请产地证时,申请人需提交以下文件资料: 原产地证明练习 一、判断题

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