Taiwan

Applied to

Assembly Element

— Identifier

— Submission

Type Tier 1

— Submission

Type Tier 2

— Submission

Type Tier 3

— Submission

Type Tier 4

— Submission

Type Tier 5

— Submission

Objective

— Submission Unit

— Applicant Name

— Applicant Corporate

Certification Authority

— Applicant Phone

Number

— Applicant Email

Address

— Invented

Names (Name/

Drug Permit

License/ Pre-

Assigned

Application

Number) — Code

— INN

— Sequence

— Related

Sequence

— Submission

Description

1 Administrative

Information and

Prescribing Information folder of the TW eCTD template

When applied to a folder in an

Assembly that is using the tw-1-0

Definition file, triggers the creation of the tw-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <envelope> element of the tw-regional.xml file. The child folders of this folder complete the remainder of the tw-regional.xml file.

Multiple comma-separated values can be provided for:

— Applicant Phone Number

— Applicant Email Address

— Invented Names

— Drug Permit License

— INN

— Related Sequence