m1-tw v. 1.0
| Field Name | Field Type | Matching UI Field | Description | Acceptable Values | Default Value |
|---|---|---|---|---|---|
| identifier | string | 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. | The entered values should pass the validation to match the format: a hexadecimal number in the form of xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx, having 32 digits and 4 hyphens. | Defaults based on the UUID from the parent application. |
| submissionTypeTier1 | string | Submission Type Tier 1 | Domestic, Import, Export Only. | ||
| submissionTypeTier2 | string | Submission Type Tier 2 | New Drugs Application, Biological Drugs Application, Generic Drug Application, Active Pharmaceutical Ingredient. | ||
| submissionTypeTier3 | string | Submission Type Tier 3 | Prescription, Over The Counter, Controlled Drugs, Nuclear Medicine, Biological Drugs, Biosimilar Drugs, Regenerative Medicine, Others. | ||
| submissionTypeTier4 | string | Submission Type Tier 4 | 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. | ||
| submissionTypeTier5 | string | Submission Type Tier 5 | 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. | ||
| submissionObjective | string | 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. | Change, Expiration, Extension, New. | |
| submissionUnitType | string | 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. | Initial, Validation Response, Response, Additional Info, Corrigendum, Reformat. | |
| applicantName | string | Applicant Name | The name of the company submitting the eCTD. | ||
| applicantCertAuth | string | Application Corporate Certification Authority | Applicants should use Corporate Certification Authority IC Card for submission. | ||
| applicantPhoneNum | string | Applicant Phone Number | Phone number of the company. | Multiple comma-separated values can be provided. | |
| applicantEmailAddr | string | Applicant Email Address | If entered value does not met [email protected] criterion
Invalid e-mail address message appears.
Multiple comma-separated values can be provided. |
||
| procedure | string | Procedure | Defines the procedure in use with the submission National is the default and the only option to be chosen. | ||
| inventedName | map | Invented Names (Name/Drug Permit License/Pre-Assigned Application Number/Code) | The group of fields that allows multiple sets of Invented Name. | Example:
field name="inventedName" type="map"><value key="2uniqueSuffix__1" value="22,3333" /><value key="2__uniqueSuffix__1" value="222" /><value key="2__uniqueSuffix__1" value="2222" /><value key="Invented NamesNameValue__uniqueSuffix__0" value="Drug Permit License" /><value key="Invented NamesNameValue__uniqueSuffix__0" value="Pre-Assigned Application Number " /><value key="Invented NamesNameValue__uniqueSuffix0" value="Code" />
|
|
| inn | string | 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. | Multiple comma-separated values can be provided | |
| sequence | string | 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. | Only digits, if not, the error appears. | |
| relatedSequence | string | 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. | Multiple comma-separated values can be provided. 'Related Sequence must be numeric' error message appears if the value is not numeric. | |
| submissionDescription | string | Submission Description | This element is used to provide a free text description of the submission. |