South Africa-v3.1


Attribute	Description
Application ID	A unique 14-character identifier number automatically issued by SAHRA for an application once it is created on SAHPRA application portal. Application ID is used for all sequences of an eCTD application and cannot be changed.
Application Number	A unique number automatically issued by SAHPRA for each product, strength, replica/clone/duplicate once an application is created or a new replica/clone is added to the existing application on SAHPRA application portal. Multiple commaseparated values can be provided.
Application Type	The type value for the Application.
APIMF Number	A unique identifier number of certified Active Pharmaceutical Ingredient Master File (APIMF). Populated, if APIMF is referenced in the eCTD application. Multiple comma-separated values can be provided.
Contact	Applicant contact data. Multiple contacts can be provided in the envelope if needed, but adding at least one local applicant contact is required. The following values must be provided for each contact: Contact Name, Contact Email, Contact Type.
Dosage Form	The dosage form of the medicinal product.
INN	The recognized International Non-proprietary Name should be given for the active ingredients and pharmaceutical drug if available. It should be written in all lower-case letters and provided exactly as officially listed in international lists like WHO INN, British Approved Names (BAN), United States Pharmacopoeia (USP) and without abbreviations. Multiple comma-separated values can be provided.


Attribute	Description
Multiple Applications (Application Number/ Proprietary Name)	Multiple Application Indicator of any replicas/clones/duplicates with proprietary name and application number for each additional application. Multiple paired values can be provided (both Application Number and Proprietary Name must be either populated or empty).
PMF Number	A unique identifier number of certified Plasma Master File (PMF). Populated, if PMF is referenced in the eCTD application. Multiple comma-separated values can be provided.
Proprietary Name	The name as proposed or registered. For API Master Files, insert drug substance name and APIMF holder name. Multiple comma-separated values can be provided.
Related Sequence	The attribute is used to group sequences associated with the same submission. This helps the agency qucklier evaluate sequences associated with a particular submission. Multiple comma-separated values can be provided. If the submission type does not set to Response to a pre-registration recommendation or post-registration, then the Related Sequence attribute must set to NONE.
Sequence Date	Indicating the date of a sequence was being submitted. The date should correlate but should not necessarily be identical to the date shown in the Letter of Application and the Application Form. The Sequence Date is mainly used to ensure the validity of the codes taken from the Defined Lists.
Sequence Number	Four-digit sequence number matching the sequence folder being submitted.
Sequence Description	The Sequence Description attribute gives the Applicant the opportunity to better describe what is being done in the Sequence.
Sequence Type	Contains all the Sequence-related information. It identifies what is happening to the Submission with the Sequence being submitted. Only one Sequence attribute can be specified per Sequence, however, multiple types of Responses can be specified as types. Responses can only be combined with other responses. Multiple values can be provided Values for Sequence Type are taken from Sequence Maintenance > Sub Filling Type Values Data Administration List.
Attribute	Description
Submission (Submission Type/Evaluation Pathway/ Submission Lead/Submission Number)	Contains all the submission-related information for the regulatory activity that is not related to a specific sequence. Multiple Submission sets can be provided if the combination is allowed in the Submission Type Matrix. For Submission Type, values are taken from Display Name attribute in the Sequence Maintenance > Filling Type Values Data Administration List. For Evaluation Pathway, values are taken from Display Name attribute in the Submission Maintenance > Evaluation Pathway Values Data Administration List. For Submission Lead, values are taken from Display Name attribute in the Submission Maintenance > Regulatory Activity Lead Values Data Administration List.
SMF Number	The Site Master File (SMF) Number for all manufacturers referenced in the eCTD application. Multiple comma-separated values can be provided.
VAMF Number	A unique identifier number of certified Vaccine Master File (VAMF). Populated, if VAMF is referenced in the eCTD application. Multiple comma-separated values can be provided.

eCTD Attributes Taiwan

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