eCTD Attributes China
China-v1.0
| Attribute | Description |
|---|---|
| Application Number | Unique identification number for an application in its full lifecycle, assigned by the regulatory agency.
The applicant obtains the application number from the regulatory agency when it submits eCTD applications for IND, NDA, ANDA for the first time. The application number format: Letter (x = NDA; y = ANDA; l = IND) + year (4 digits) + 5 digit serial number. Example: x201912345. |
| Application Type | Describes the application purpose. Example: IND, NDA, ANDA |
| Product Type | Describes the product classification information. Example: Chemical Product, Biological Product. |
| Original Number | The basic and permanent number given to a drug entering the registration approval process. The original number is assigned by the regulatory agency and is used as the unique code to identify the applicant, active ingredient (API), and dosage form.
The original number format: year (4 digits) + 6-digit serial number. Example: 2019123456. |
| Related Sequence | Used to group the sequences in one application according to the regulatory activity. The first sequence in one regulatory activity is the related sequence for all other sequences submitted in the regulatory activity. |
| Regulatory Activity Type | Describes the purpose of the regulatory activity. |
| Sequence Number | A unique 4-digit character string in the application, a unique identifier that distinguishes different submitted sequences.
The applicant shall submit the application from 0000 and the sequence number shall be incremented by 1 for each submission. The application shall be submitted based on sequence. |
| Sequence Type | Describes the purpose of the sequence. |
| Sequence Description | Brief description of the sequence purpose, used to distinguish the sequence of similar type. The sequence description length shall be controlled within 120 Chinese characters. The sequence description shall not substitute the reply and cover letter to the request raised by the regulatory agency, and shall not be used to raise questions to the regulatory agency. |
| Sequence Contact Name | Name of the contact person responsible for the sequence. |
| Sequence Contact Telephone | Telephone number of the contact person responsible for the sequence. |
| Sequence Contact Email | Email address of the contact person responsible for the sequence. |