来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201521695929736/
如何提交ASMF？
24. How should I submit an active-substance master file (ASMF)? Rev. August 2014
我应该如何提交一份ASMF文件？2014年4月，修订
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000020.jsp&mid=WC0b01ac0580022713#
Annex I to Directive 2001/83/EC describes the concept of an open and closed Active Substance Master File (ASMF) and specifies that:
指令2001/83/EC附录1中描述了ASMF公开部分和保密部分的概念，特别指明：
“For a well-defined active substance, the active substance manufacturer or the applicant may arrange for the:
“对于一个其性策已界定良好的活性物质，活性物质生产商或制剂申报人可以安排：”
i) Detailed description of the manufacturing process 详细的生产工艺描述
ii) Quality control during the manufacture, and 生产过程中的质量控制
iii) Process validation 工艺验证
to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File.
放在一个单独的文件中，由活性物质的生产商作为一份ASMF直接提交给相应药监当局
In this case, the manufacturer shall, however, provide the applicant with all of the data, which may be necessary for the latter to take the responsibility for the medicinal product…”
在这种情况下，生产商应向申报人提交所有之后申报人对药品承担责任所必须的数据
It should be emphasized that the concept of the ASMF shall only apply to a well-defined active substance and cannot be used for excipients, finished products and biological active substances. The information related to excipients, finished products and biological active substances shall be provided within the Marketing Authorisation Application (MAA) by the applicant.
要强调的是，ASMF的概念仅适用于性质已良好界定的活性物质，不适用于辅料、制剂和生物活性物质。与辅料、制剂和生物类活性物质相关的信息应在MAA中由申报人提交。
In case an application under the Centralised Procedure includes the submission of an Active Substance Master File (previously referred to as European Drug Master File (EDMF)), applicants should be aware of the fact that, as mentioned in the Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02), an ASMF consists of 2 parts:
如果采用了集中审评程序提交申报资料，包括ASMF（之前称为EDMF）提交，则申报人要明白，正如ASMF程序指南 (CPMP/QWP/227/02)中提到的，一份ASFM包括2个部分：
l An ASMF Applicant’s Part, also referred to as Open Part, which shall be at the disposal of the applicant.
l 一个ASMF申请人部分，也称为公开部分，应由申报人处理
l An ASMF Restricted Part, also referred to as Closed Part, which is a confidential document closed to the applicant.
l 一个ASMF受控部分，也称为保密部分，它是不对申报人公开的一份保密文件
Both parts need to be separated and follow the structure of the Module 3.2.S of the CTD.
两个部分需要分开，根据CET模块3.2.S的结构编写。
The content requirements as described in the above mentioned Guideline should be followed.
应遵守上述指南中所述的内容要求。
It is necessary for the applicant and the ASMF holder to liaise to ensure that the ASMF including all necessary documents are synchronized to arrive at ideally the same time as the planned MAA to be submitted by the applicant, although an interval of some days may be allowed. Note that the marketing authorisation application cannot be validated until all the necessary documents are received in a satisfactory form. This also applies to the ASMF-related responses to Day 120 LoQ and Day 180 LoOI. Applicants should be aware that the procedure cannot re-start until the responses from the ASMF holder are received by the Agency.
申报人和ASMF持有人应取得联系，保证ASMF包括所有必需的文件，并与计划的MAA提交时间同步到达药监当局，当然前后数天的差异是允许的。要注意的是，在所有必须的文件被收到，且格式符合要求之前，药监部门不能对上市许可申报进行核查。这也适用于与ASMF相关的120天LOQ和180天LOOI回复。申报人应明白只有在药监当局收到ASMF持有人的回复后，该程序才会重新开始。
Non applicability of ASMF concept to biological active substances
生物类活性物质不适用ASMF概念
Further to clarifications from the European Commission on the interpretation of Directive 2001/83/EC as amended, and the subsequent announcement in the October 2004 CHMP Monthly report, the ASMF concept is not acceptable for biological medicinal products.
欧盟委员会关于指令2001/83/EC的解释的澄清以外，在2004年10月CHMP月报中又进行了宣布，ASMF概念被用于生物类药品是不可接受。
The characterisation and determination of biological active substances requires not only a combination of physico-chemical and biological testing, but also extensive knowledge of the production process and its control.
生物类活性物质的特性和检测不仅要求复合的理化和生物类检测，还需要有大量的生产工艺及其控制的知识。
The MAH/applicant for a biological medicinal product could therefore not comply with the requirement to ‘take responsibility for the medicinal product’ without having full and transparent access to these quality-related data. The use of an ASMF would prevent such access, and should therefore not be allowed for biological active substances.
没有全面和透明的质量标准数据前提下，生物类药品MAH/申报人无法符合“承担药品责任”的要求。使用一份ASMF将阻止申报人获得这些资料，因此ASMF不能允许用于生物类活性物质。
In addition, active substances, which are present in certain medicinal products such as vaccines or cell therapy medicinal products, do not fit with the concept of a ‘well-defined’ active substance.
此外，活性物质，如果出现在例如疫苗或细胞治疗药品中，不满足“良好界定”的活性物质的概念。
Non applicability of ASMF concept of open and closed parts to Vaccine Antigen Master File (VAMF) and Plasma Master File (PMF)
公开部分和保密部分的ASMF概念不适用于疫苗主文件（VAMF）和血浆主文件（PMF）
The concept of the ASMF does not apply to blood derived medicinal products and vaccine antigens. In this context, the manufacturer can submit a PMF or a VAMF.
ASMF概念不适用于血液制品和疫苗抗原。在这种情况下，生产商可以提交PMF或VAMF。
Regarding the VAMF, the legislation specifies that the VAMF holder cannot differ from the MAH/applicant for the concerned medicinal product: there is hence no rationale for an open /closed parts system.
关于VAMF，法律指骨出VAMF持有人必须与MAH/相关药品申报人相同，因此没有理由采用公开/保密部分系统。
For VAMF linked MAs, if a particular MAH name and address are not identical to the name and address of the proposed VAMF certificate holder, a relevant declaration should be provided attached to the application form, stating that the MA applicant and the MAH belong to the same mother group of companies, which share the same data package.
对于与MA相关连的VAMF，如果特定的MAH名称和地址不同于所提交的VAMF证书持有人名称和地址，则应提交相关的声明附于申报表中，说明MA申报人和MAH持有的属于同一个集团，可以共享相同的数据包。
For the PMF the legislation specifies that where the MAH/applicant differs from the holder of the PMF, the PMF shall be made available to the MAH/applicant for submission to the competent authority.
对于PMF，法规说明如果MAH/申报人不同于PMF持有人，则MAH/申报人应可以获取PMF提交给药监当局。
References 参考资料
· Annex I to the Directive 2001/83/EC, as amended
· Guideline on Active Substance Master File Procedure (CPMP/QWP/227/02)
· Procedural announcement CHMP Monthly report October 2004(EMEA/CHMP/119155/2004)
· CMD(h) – Overview of Biological Active Substances of non-recombinant origin
· Guideline on requirements for Vaccine Antigen Master File (VAMF) certification (EMEA/CPMP/4548/03/Final/Rev1)
· Guideline on requirements for Plasma Master File (PMF) certification (CPMP/BWP/4663/03)
What data should be submitted by the ASMF holder? Rev. Dec 2013
ASMF持有人要提交哪些数据？2013年12月修订
In the first submission of an ASMF with an allocated EMEA ASMF reference number, the ASMF holder is required to submit:
首次提交已给定EMEA ASMF索引号的ASMF时，ASMF持有人要提交：
l ASMF dossier (Applicant’s part, Restricted part, Quality Overall Summary and Expert’s curriculum vitae);
l ASMF文档（公开部分、保密部分、质量综述和专家简历）
l Letter of Access (Annex 2 of the ASMF Guideline);
l 授权信（ASMF指南附录2）
l Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline);
l 申报函和详细行政信息（ASMF指南附录3）
l A commitment to inform the applicant and the EMA of any change in the ASMF to be provided either as a separate letter or within the Letter of Access (Annex 2 of the ASMF Guideline).
l 保证会将ASMF的任何变更通知EMA和制剂申报人的承诺函，可以是单独的一封函，也可以放在授权信内（ASMF指南附录2）
In later marketing authorisation application or variations submissions referencing to an already submitted ASMF with an allocated EMEA/ASMF number, the ASMF holder is only required to submit:
在随后的引用已给定EMEA ASMF索引号的已提交的ASMF的上市许可申报或变更申报中，ASMF持有人只需要提交：
l Letter of Access (Annex 2 of the ASMF Guideline);
l 授权信（ASMF指南附录2）
l Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline);
l 申报函和详细行政信息（ASMF指南附录3）
l The relevant revised sections of the ASMF dossier reflecting changes to the previously accepted version, as applicable;
l 适当时，ASMF文档相关修订部分，以反映对之前已接受的版本的变更
l A commitment to inform the applicant and the EMA of any change in the ASMF to be provided either as a separate letter or within the Letter of Access (Annex 2 of the ASMF Guideline).
l 保证会将ASMF的任何变更通知EMA和制剂申报人的承诺函，可以是单独的一封函，也可以放在授权信内（ASMF指南附录2）
The Letter of Access and the Letter of Commitment to inform the applicant about any changes in the ASMF should be included both in the application form submitted by the applicant (Annexes 5.10 and 5.11) and also in the ASMF submitted by the ASMF holder.
授权信和保证会将ASMF变更通知制剂申报人的承诺函应包括在制剂申报人的申报表（附录5.10和5.11）中，以及ASMF持有提交的ASMF中。
The contact details of the ASMF holder contact person (including contact email address) must be the same in the Cover Letter of the ASMF, in the Letter of Access and the Application Form (Module 1.2 of the eCTD or NeeS submission).
ASMF持有人联系人的联系信息（包括联系邮箱地址）必须与ASMF封面函、授权信和申报表格（eCTD或NeeS申报中模块1.2）中的相同。
ASMF holders are reminded that any initial submission and update to an ASMF should be accompanied by theSubmission Letter and Administrative Details (Annex 3 of the ASMF Guideline) dully filled as detailed in the instructions provided in the Additional guidance on documents relating to an active substance master file. Either an EMEA/ASMF/xxxxx number or EU/ASMF/xxxxx number has to be entered.
要提醒ASMF持有人的是，所有初始申报资料和对ASMF的更新应同时提交一份申报函和详细行政信息（ASMF指南附录3），其中要按照“ASMF相关文件附加指南”中的指示详细填写完整。其中要填入EMEA/ASMF/xxxx索引号或EU/ASMF/xxxx索引号。
New MAA or MAV should always reference the last version of the ASMF submitted. This will be subject to compliance checks during validation of the MAA and MAV.
新的MAA或MAV应保持引用所提交的ASMF最新版本。在MAA和MAV的核实中要检查是否符合。
The ASMF dossier and any subsequent updates should only be submitted once.
ASMF文档和之后的所有更新应只提交一次。
What data should be submitted by the applicant or MAH? Rev. Dec 2013
制剂申报人或MAH应提交哪些数据？2013年12月修订
In all cases, the applicant (in the context of a MAA) or MAH (in the context of a MAV) should submit:
在所有情形下，制剂申报人（MAA的情形下）或MAH（MAV的情形下）应提交：
l MAA and MAV application form stating the correct EMEA ASMF reference number;
l MAA和MAV申报表给出正确的EMEA ASMF索引号
l Copy of the Letter of Access (Annex 2 of the ASMF Guideline), as applicable;
l 授权信副本（ASMF指南附录2），适用时
l Copy of the complete current version of the Applicant’s part of the ASMF in Module 3 or its revised sections, as applicable;
l 完整的ASMF公开部分现行版本副本模块3或其修订后的部分，适当时
l Copy of the commitment from the ASMF holder to inform the applicant and the EMA of any change in the ASMF to be provided either as a separate letter or within the Letter of Access (Annex 2 of the ASMF Guideline).
l ASMF持有人保证会通知制剂申报人和EMA所有对ASMF的变更的承诺函，可以是单独一封件，也可以是包括在授权信中（ASMF指南附录2）
The Letter of Access and the Letter of Commitment to inform the applicant about any changes in the ASMF should be included both in the application form submitted by the applicant (Annexes 5.10 and 5.11) and also in the ASMF submitted by the ASMF holder.
授权信和保证通知申报人关于其ASMF变更的承诺函应包括在申报人提交的申报资料（附录5.10和5.11）中，同时也要包括在ASMF提交的ASMF中。
The latest version of the ASMF submitted in the context of a previous centralised procedure will be considered the current version of that ASMF. The current version of the ASMF should correspond to the version of the ASMF Applicant’s part declared in a new MAA or MAV form and included in Module 3. This will be subject to compliance checks during validation of the MAA and MAV.
之前集中评审程序中提交的最新版本的ASMF将被认为是该ASMF的现行版本。ASMF现行版本应对应新的MAA或MAV表中声明的ASMF公开部分的版本，并包括在模块3中。在MAA和MAV核查中将对该版本号的符合性进行检查。
Example: 例
The version of EMEA/ASMF/12345 (EMA/ASMF/reference number) currently held at the Agency is: AP January 2012/RP April 2013.
EMA处现持有EMEA/ASMF/12345(EMA/ASMF/索引号)版本号：公开部分为2012年1月/保密部分2013年4月
If the version of the ASMF included in the Module 3 of the MAA and referenced in the application form is AP November 2011, the applicant will be requested to update Module 3 and the application form according to the current version of the EMEA/ASMF/12345.
如果在MAA模块3中包括，在申报表中引用的ASMF公开部分版本号为AP2011年11月，则申报人会被要求对模块3进行更新，并根据现行的EMEA/ASMF/12345的版本号对申报表进行更新。
Equally, if the version of the ASMF included in the Module 3 of the MAA and referenced in the application form is AP December 2012, the ASMF holder will be requested to submit the latest version of the ASMF together with the Annex 3 of the ASMF Guideline.
同样，如果包括在MAA的模块2中的ASMF版本号以及在申报表中引用的版本号为AP2012年12月，则ASMF持有人将被要求提交最新的ASMF版本，以及ASMF指南附录3的表格内容。
ASMF Holders are reminded of their responsibility to inform the MAHs of any changes to their ASMFs. Similarly, MAHs are reminded of their legal obligation to submit the applicable variation to their MAs when changes are proposed to the ASMF, i.e. when an updated version of the ASMF is submitted, the MA(s) linked to that ASMF will only integrate the ASMF update once the applicable variation is submitted and positively concluded.
要提醒ASMF持有人的是，ASMF持有人有责任通知MAH任何与其ASMF有关的变更。同样，要提醒MAH持有人的是，当ASMF提交了变更时，了ASMF持有人提交了更新版本时，MAH持有人有法定义务提交相应的变更给其MA，只有当提交了适当的变更申报，并作出下面的结论时，与ASMF相链接的MA才算完整。
The applicant should submit the Applicant’s Part of the ASMF. It should be included in their application within Module 3.2.S of the dossier. The ASMF holder should only submit updates to the Applicant’s Part (which should be identical to the one provided by the applicant) and/or Restricted Part, as applicable, in the context of a MAA or MAV. Both parts should be the latest versions available of the ASMF. It is recommended to include a table summarising those changes made to the ASMF compared to the previous version.
申报人应提交ASMF的公开部分。它应该包括在其申报资料中的模块 3.2.S中。对于MAA或MAV来说，ASMF持有人应只提交公开部分（应与提交给申报人的一样）和/或保密部分的更新。建议包括一份表格，汇总ASMF中这些与前版本相比较的变更。
Applicants should note that the ASMF constitutes an integral part of the dossier and therefore it should be always made available to the EMA and CHMP Members.
申报人应注意ASMF构成申报文件不可分割的一部分，因此必须使得EMA和CHMP成员总能获得该部分资料。
The applicant is responsible for the submission of all necessary documents to the EMA.
制剂申报人对所有必须提交给EMA的文件承担责任。
It should be noted that although the ASMF procedure is developed to keep intellectual property confidential, it is also permitted to use the procedure when the applicant is also the manufacturer of the active substance.
要注意的是尽管ASMF程序建立是为了保护知识产权，如果制剂申报人也是原料药的生产商的话，也是可以使用该程序的。
Additional information on the ASMF procedure can be found in the ASMF WG webpage .
ASMF程序附加信息参见上述网页。
What is the EMEA/ASMF reference number? Rev. Dec 2013
什么是EMEA/ASMF索引号？2013年12月修订
From 1 September 2013, ASMF holders submitting their ASMF dossiers relating to a Centrally Authorised Product are asked to send it to the Agency and Committee Members only once.
自2013年9月1日起，要求提交与集中审评产品相关的ASMF文档的ASMF持有人只向药监当局提交一次。
According to the new ASMF submission rules the Agency will assign a reference number on request prior to submission of the ASMF that can cover multiple CAPs.
根据新的ASMF提交规范，药监机构将在ASMF提交前给定一个索引号，该索引号将覆盖多个CAPs.
The EMEA/ASMF/XXXXX number is an internal reference number sequentially assigned by the EMA to enable an appropriate data lifecycle management of ASMFs used in one or more centralised Marketing Authorisation.
EMEA/ASMF/XXXXX索引号是一个内部索引编号，由EMA顺序给定，以使得用于一个或多个集中评审上市许可的ASMF能进行适当的数据生命周期管理。
The EMEA ASMF reference number does not replace the responsibility of the ASMF holders to version control their ASMF (in accordance with GMP) nor replaces their own ASMF numbering system.
EMEA ASMF索引号并不替代ASMF持有人控制其ASMF版本号的责任（符合GMP），也不会代替其自身的ASMF编号体系。
Who should request an EMEA ASMF reference number? Rev. Dec 2013
谁应该索取EMEA ASMF索引号？2013年12月
The EMEA ASMF reference number should be requested by the ASMF holder for:
EMEA ASMF索引号应由ASMF持有人在以下情况下索取
l new ASMFs submitted for MAAs and MAVs as of 1 September 2013. From this date, reference to an EMEA ASMF number will be checked at validation,
l 为2013年9月1日之后的MAA和MAV提交的新ASMF。自上述日期起，EMEA ASMF索引号将在核实时进行检查。
l ASMFs previously submitted to the EMA when referenced in a new MAA or MAV. The request for the EMEA ASMF reference number should be made before submission of a new MAA or MAV to update the ASMF.
l 之前提交给EMA的ASMF在一个新的MAA或MAV里被引用时。应在新的MAA或MAV提交之前索取EMEA ASMF索引号，更新ASMF。
l ASMFs submitted in relation to a variation application.
l 与制剂提交变更申报有关的ASMF申报
For previously submitted ASMFs, in cases where the ASMF is used in more than one MA the ASMF Holder should only request one EMEA ASMF reference number, when applicable[1]. The allocated EMEA ASMF reference number should be communicated to the applicant or MAH, so that reference to the EMEA/ASMF/XXXXX number is made in all future submissions.
对于之前提交的ASMF，如果ASMF用于不止一个MA，适当时，ASMF持有人应仅申报一个EMEA ASMF索引号。应将给定的EMEA ASMF索引号通知制剂申报人或MAH，这样未来所有的申报资料中将引用该EMEA/ASMF/XXXXX索引号。
When and how to request an EMEA ASMF reference number?
什么时候、如何索取EMEA ASMF索引号？
Up to two weeks before submitting a complete ASMF, or an update to an already submitted ASMF, the ASMF holder should request the EMEA ASMF reference number. The request should be sent to [url=mailto
A-BUS@ema.europa.eu]PA-BUS@ema.europa.eu[/url].
在提交完整的ASMF，或为已提交的ASMF提交更新之前2周，ASMF持有人应索取EMEA ASMF索引号。索取要求应提交给上述邮箱。
Agency ASMF reference numbers are allocated sequentially. A request form is available.
药监机构随后会给定ASMF索引号。上述网址可以找到“编号索取表”格式。
The EMEA ASMF reference number allocated by the Agency should be referenced in all subsequent communications (e.g. in response to a validation issue, List of Questions, List of Outstanding Issues, upcoming variation) and should always be included in the following documents:
由药监机构给定的EMEA ASMF索引号应在所有之后的沟通中引用（例如，回复核实问题、问题清单、重要问题清单、之后的变更），还必须包括在以下文件中：
l MAA (in the field of the National ASMF number) or MAV application form (in the Present and Proposed field);
l MAA（在国家ASMF编号格子里）或MAV申报表（在现在的或修订后的格子里）
l Letter of Access (Annex 2 of the ASMF Guideline);
l 授权信（ASMF指南附录2）
l Submission Letter and Administrative Details (Annex 3 of the ASMF Guideline).
l 申报函和详细行政信息（ASMF指南附录3）
It is the responsibility of the ASMF holder to inform the applicant of a MAA or MAV of the allocated EMEA ASMF reference number. Failure to state a valid EMEA ASMF reference number on the MAA or MAV form will trigger validation questions and may delay the start of procedure.
ASMF持有人有责任通知MAA或MAV持有人所给定的EMEA ASMF索引号。如果在MAA或MAV申报表中未说明EMEA ASMF索引号可能会引起核实问题，从而可能导致审评程序延迟启动。
EMEA ASMF or EU ASMF reference number? Rev. Dec 2013
EMEA ASMF或EU ASMF索引号？2013年12月修订
The EU/ASMF reference number allows for the identification by all Competent Authorities(National Competent Authorities and EMA) of ASMFs used in centralised and national (Decentralised and Mutual Recognition) MAAs or MAVs, and therefore enabling the ASMF Assessment Report Work Sharing (ASMF AR WS) procedure.
EU/ASMF索引号使得所有有资质的药监机构（国家药监机构和EMA）可以对用于集中审评和国家审评程序（分散和互认）MAA或MAV的ASMF进行识别，从而使得ASMF评估报告工作分享（ASMF AR WS）可以实现。
More information on the ASMF AR WS will be made available closer to the start of the pilot phase (1 December 2013) in the dedicated ASMF WG webpage .
关于ASMF AR WS的更多信息将在试行期开始前期（2013年12月1日）在上述专用网站找到。
ASMF holders should either have an EMEA/ASMF/ reference number or an EU/ASMF/ reference number before submitting an ASMF. Both numbering systems will run in parallel as of the start of the pilot phase of the ASMF AR WS. ASMF holders are encouraged to request an EU/ASMF/reference number if the ASMF is expected to be used in centralised and national applications.
在提交ASMF前，ASMF持有人应有EMEA/ASMF索引号或EU/ASMF/索引号。2个编号系统将从ASMF AR WS试行阶段开始平行运行。如果一份ASMF将要用于集中评审程序和国家申报程序，鼓励ASMF持有人索取EU/ASMF索引号。
Which format and submission channel should be used for submitting ASMFs? Rev. Aug 2014
在ASMF申报时应使用哪种格式和提交途径？2014年8月，修订
Under the new ASMF submission requirements, the following formats are accepted for ASMF submissions:
根据新的ASMF申报要求，以下格式是可以接受的：
· Electronic Common Technical Document (eCTD);
· 电子通用技术文件格式（eCTD）
· Non-eCTD electronic submission (NeeS).
· 非eCTD电子提交（NeeS）
Guidance on the above formats can be found on the eSubmission website. Additional, please take a note of the EMA’sstatement of intent of the mandatory use of eSubmission Gateway and WebClient.
上述格式的指南可以在电子提交网站上找到。另外，请注意EMA关于必须使用电子提交的用意说明和网络客户端。
Submission requirements for the different Committee (Co-) Rapporteurs
不同报告起草人委员会的提交要求
ASMF holders must submit the application to all (Co-) Rapporteurs, otherwise there may be a delay in the start of the procedure due to the time lapse between the validation by the Agency and the confirmation from the (Co-) Rapporteurs that they have received the dossier. For a full overview of the submission requirements for the different Committee (Co?) Rapporteurs see: Dossier requirements for Centrally Authorised Products (CAPs).
ASMF持有人必须将申报资料提交给所有报告起草人，否则将可能会因为药监机构核实时间和报告起草人确认收到文档的时间差而延迟评审程序的开始时间。关于不同报告起草人对申报资料的要求全部信息，请参见“集中审评程序药品（CAPs）的申报资料要求”。
The above method and requirements also apply to the submission of responses to List of Questions / List of Outstanding Issues.
上述方法和要求同样适用于重要问题清单/问题清单回复资料的提交。
How to proceed if the ASMF was previously submitted in paper format? Rev. Dec 2013
如果ASMF之前已采用纸质文件提交，要怎么继续？2013年12月，修订
The ASMF holder of ASMFs previously submitted in paper format should request an EMEA ASMF reference number as indicated above.
之前已采用纸质文件提交ASMF的ASMF持有人应按上述指示索取EMEA ASMF索引号。
After the reference number is allocated the ASMF holder should submit the ASMF in an accepted electronic format (Electronic Common Technical Document (eCTD ) or Non-eCTD electronic submission (NeeS ).
在给定索引号后，ASMF持有人应采用可接受的电子格式提交ASMF（电子通用技术文档eCTD格式或非eCTD电子申报格式(NeeS)。
How to proceed if there is an existing eCTD life-cycle for the ASMF? NEW Dec 2013
如果一份ASMF已有eCTD生命周期，应如何继续？2013年12月，新
ASMF holders need to request the EMEA/ASMF number by filling the request form. The EMA will provide the requestor with the new number within 3working days. Please note that this number is NOT equivalent of EU/ASMF number and should never be inter-changed.
ASMF持有人应填写申请表索取EMEA/ASMF索引号。EMA将在3个工作日内向申请人提供新的索引编号。请注意该编号不等同于EU/ASMF索引号，绝不能相互搞混。
If the ASMF holder already has more than one eCTD life-cycle filed for the given substance, they will need to select one of these (informing the EMA in the cover letter which one it will be) and follow the eCTD life-cycle of the selected ‘product’ only. This, selected life-cycle will, then receive a new EMEA/ASMF/01xxx number covering all listed CAPs.
如果ASMF持有人已经为同一个原料药提交了不止一个eCTD生命周期，他们需要选择其中之一（在封面函中通知EMA要选择哪一个），之后仅维护所选择的“产品”eCTD生命周期即可。这样，所选择的生命周期将收到一个新的EMEA/ASMF/01xxx索引号，覆盖所有列出的集中评审药品。
Once the ASMF holder is submitting an update or new version to the ASMF, they have to do so with this new number. The ASMF holder will have to prepare a new sequence (increasing by one) in which (module 1, cover letter) they declare that the previously submitted ASMF version has not been modified since it was last submitted.
一旦ASMF持有人提交了更新或新的ASMF版本，则其必须沿用新的索引号。该ASMF持有人必须准备一份新的序列（顺序增加一位），在新的序列中（模块1，封面函），持有人要声明之前提交的ASMF版本从最后一次提交起并未进行修改。
If there have been modifications (new version) since the last ASMF submission, additonally the relevant modules within this new eCTD sequence will have to be updated.
如果自上次ASMF提交后，进行了修改（新版本），则在新的eCTD序列里的相关模块必须要进行更新。
ASMF holders have to inform all MAH(s) about the new EMEA/ASMF/xxxxx number and if an update is submitted to an ASMF related to their Centrally Authorised Product (the MAH should then submit the relevant variation application)
ASMF持有人必须通知所有MAH持有人该新的EMEA/ASMF/xxxx索引号，以及是否向与其CAP相关的ASMF提交了更新（MAH随后应提交相应的变更申报）。
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