ICH Specification V3.2.2 一致，模組 1-5 所應檢附之資料依藥品
查驗登記準則辦理，其他注意事項請參考國際醫藥法規協和會有
關電子通用技術文件之相關規範(ICH eCTD V3.2.2)。
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(一) 模組 1— tw-envelope 及行政資料 1. tw-envelope
使用 eCTD 送件軟體製備送件資料，需在軟體中登打 tw-envelope 規範之資料。
除了「Drug permit license」 之外，其餘欄位均為必填欄位，
Element Attribute Description/Instructions Example Occurrence
tw-envelope Root element that provides meta-data for the submission. NA Unique
Identifier 本欄位填入UUID，相同的UUID將用於eCTD送件申請的所有序列 NA Unique
submission Provides administrative information associated with the submission. N/A Unique
type 國產
(Domestic)- 新藥查驗登記 (New Drugs Application)- 處 方
(Prescription)- 新 成 分 (New Chemical Entity, NCE) The Counter, OTC)
管制藥品
新 成 分 (New Chemical Entity, NCE)
新療效 (New Indication)
新複方 (New
(Controlled Drugs)
核子醫學
Combination)
新劑型 (New
24 (Nuclear Medicine)
其他 (Others)
Dosage Form)
新使用途徑 (New
(Biological Drugs Application)
□生物藥品 (Biological Drugs)
生物相似性藥品
(Biosimilar Drugs)
再生醫療製劑
(Regenerative Medicine)
基因工程藥品
(Genetic Engineering)
疫苗藥品 (Vaccine)
人用血漿藥品
(Plasma Derivative)
細胞治療製劑
(Cell Therapy)
基因治療製劑 (Gene Chemical Entity, NCE) Dosage Form)
新使用途徑
(New
Administration)
新使用劑量
(New Dosage)
新單位含量
(New Strength)
其他 (Others)
學名藥查驗登記 處方 監視 (Safety 符合基準
(Comply with OTC Criteria)
不符合基準 (Generic Drug
Application)
(Prescription)
非 處 方 (Over The
Monitoring)
非監視 (Non- Counter, OTC)
管制藥品
(Controlled Drugs)
Safety Monitoring)
其他 (Others)
25 原料藥(Active
Pharmaceutical Ingredient)
管制藥品 (Controlled Drugs)
其他 (Others)
(Not Comply with OTC Criteria)
其他 (Others)
Element Attribute Description/Instructions Example Occurrence
目的 objective
說明該次送件之主要目的，有(1)新申請案；(2)變更；(3)展延；(4)註銷。
The high-level handling of the information submitted as part of variation(s) and extension applications. The
following are the valid values:
(1) New: A new submission with the pre-assigned application number.
(2) Change: A subsequent submission in order to make any variation in comparison to previous submission.
(3) Extension: An activity to apply for extension of drug permit license.
(4) Expiration: An activity to apply for cancellation of drug permit license.
New Unique
submission- unit
送件種類
type
說明該次送件較詳細的子活動，有(1)首次送件、(2)驗證回復、(3)回復、(4)附加訊息、(5)更正、(6) 格式轉換。
Submission unit type describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity. The following are the valid values:
(1) initial: Initial submission to start any regulatory activity
response Unique
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(2) validation-response: For rectifying business validation issues.
(3) response: submission unit type that contains the response to any kind of question, out-standing issues information requested by the agency
(4) additional-info: Other additional Information (could include, for example, missing files) and should only be used, if validation-response or response is not suitable
(5) corrigendum: Correction to the published annexes in the national procedure (usually shortly after approval)
(6) reformat: Intended to support the reformatting of an existing submission application from any format to eCTD, i.e. a baseline eCTD submission containing no content change and which will not be subject to review (see example below). This type will always be used together with the submission type ‘none’.
Element Attribute Description/Instructions Example Occurrence
申請者
applicant
name
遞交eCTD申請的公司名。
The name of the company submitting the eCTD.
Pharma Company Ltd.
Unique
Corporate Certificati on Authority
公司的工商憑證IC卡號。
Applicants should use Corporate Certification Authority IC Card for submission.
MG000000000 00005
Unique
phone number
公司電話。
Phone number of the company.
Repeatable
Email address
公司電子郵件信箱。
Email address of the company.
Repeatable
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Defines the procedure in use with the submission (1) national (default and the only option to be chosen)
national Unique
Element Attribute Description/Instructions Example Occurrence
invented- name
藥品名稱。
name
The name of the medicinal product. WonderPill Repeatable
藥品許可證。
Drug permit license
Each drug permit license is defined by unique invented name, dose and ingredient.
Drug permit license need to be provided by applicants only when submission objective is ‘change’ or
‘extension’.
衛署藥製字第
001375號 Repeatable
取號號碼 pre- assigned application number
填寫在署內系統取得的取號號碼。
The number as the evidence of permission to submit. (e.g. YYYYMMDD##)
2020031101 Unique
高低劑量對照 code
填寫在署內系統取得的取號號碼，並加上高低劑量。
The code to link drug permit license. (e.g. YYYYMMDD##DOSE)
202003110150
International Non-proprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A non-proprietary
Pioglitazone hydrochloride
Repeatable
28 name is also known as a generic name.
序列
sequence
This is the sequence number of the submission – this should start at 0000 for the initial submission, and then increase incrementally with each subsequent submission related to the same product, e.g. 0000, 0001, 0002, 0003, etc.
0000 Unique
Element Attribute Description/Instructions Example Occurrence
相關序列
related- sequence
與該次送件相關的先前序列。
This is the sequence number of previous submission(s) to which this submission relates,
e.g. the responses to questions to a particular variation. In the case of submission unit types ‘initial’ and
‘reformat’, related sequence is identical to the sequence number.
0001 Repeatable
序列描述 submission- description
對於送件內容進行描述。
This element is used to provide a free text description of the submission.
Response to D120 LOQ
Unique
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