Calyx RIM Publisher

eCTD Attributes Taiwan

You can use the following attributes to describe eCTD submissions for Taiwan.

Taiwan-v1.0

Attribute Description
Identifier A UUID as specified by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. The same UUID must be used for all sequences of an eCTD application.
Submission Type Tier 1 Examples: Domestic, Import, Export Only.
Submission Type Tier 2 Examples: New Drugs Application, Biological Drugs Application,Generic Drug Application, Active Pharmaceutical Ingredient.
Submission Type Tier 3 Examples: Prescription, Over The Counter, Controlled Drugs, Nuclear Medicine, Biological Drugs, Biosimilar Drugs, Regenerative Medicine, Others.
Submission Type Tier 4 Examples: New Chemical Entity, New Indication, New Combination, New Dosage Form, New Administration, New Dosage, New Strength, Genetic Engineering, Vaccine, Plasma Derivative, Cell Therapy, Gene Therapy, Tissue Engineering, Allergen, Safety Monitoring, Non-Safety Monitoring, Others.
Submission Type Tier 5 Examples: New Chemical Entity, New Indication, New Combination, New Dosage Form, New Administration, New Dosage, New Strength, Comply With OTC Criteria, Not Comply With OTC Criteria, Others.
Submission Objective Explains the main purpose of this submission. The high-level handling of the information submitted as part of variation(s) and extension applications.
Submission Unit Submission unit type describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity.
Applicant Name The name of the company submitting the eCTD.
Applicant Corporate Certification Authority Applicants should use Corporate Certification Authority IC Card for submission.
Applicant Phone Number Phone number of the company.
Applicant Email Address Email address of the company.
Invented Name (Name, Drug Permit License, Pre-Assigned Application Number, Code ) Fields group that allows multiple sets of Invented Name of the medicinal product including:
  • the name of the medicinal product.
  • the drug permit license defined by unique invented name, dose and ingredient. Drug Permit License can have multiple comma-separated values.
  • the pre-assigned application number as the number as the evidence of permission to submit. (For example, YYYYMMDD##).
  • the code to link drug permit license. (For example, YYYYMMDD##DOSE).
Multiple items can be provided.
INN 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.
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. For example, 0000, 0001, 0002, 0003, etc.
Related Sequence This is the sequence number of previous submission(s) to which this submission relates. For example, 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.
Submission Description Text field for describing a submission.