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APIMF Submissions�

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The New Portal

Novus3 - Developers
Log in for APIMF holder
Portal – Automatic Creation of…

APIMF number

Upload Sequences
September 2024 Planned Launch

We are very excited about the new Portal that is scheduled to be ready for release and use in July 2024
The new SAHPRA Application Portal is a subset of a much larger project where SAHPRA is digitizing our process and content. It is the area, however, where Applicant interactions are planned, where Applicants will manage their Applications and upload their sequences
The Portal will help us in automating the processes of providing Application information including the new Application ID, the Application Numbers as they have always been and the new Submission Numbers.

Numbers will be provided instantaneously, NO MORE WAITING WEEKS to receive critical information that potentially delayed your ability to submit.

Uploading Sequences will become user functionality and a user-friendly solution.

Applicants will have an opportunity to quality control their content before deciding when to submit it, push it over to SAHPRA for processing
Ability to submit will be linked to our SAGE system, confirmation of payment via SAGE will be required before a sequence can be submitted.

Eliminating the requirement for 1.2.2.1 Proof of Payment in the future

All of this magic is expected to be rolled out in July this year

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Process Automation

VECTOR/LORENZ RIM Solutions for evaluation
Sequence Trigger File
Automation

Sequence Validation
Validation Communication
Sequence Transfer
Sequence Upload into Evaluation System
Sequence Assignment

We are equally excited about the amount of work that will be saved by our new Automation capabilities
The trigger file is required and must be created manually and uploaded by the applicant until the Portal goes live in July

We are providing an Excel file on the eCTD Website which can be used to create the trigger file in a more user-friendly manner
The trigger file is similar to the file used by ECOWAS and the AU-TGA for their eSubmissions and will also be used for the SAHPRA eSubmissions – Guidance forthcoming.

Automation will begin 1 April 2024.

All sequences submitted after the 20 March administrative freeze start must be submitted using a trigger file [this includes the AMA applications]
This means, we will begin using the trigger with the current FTP server, before the Portal is launched in July
All content that was submitted in other locations e.g., Variations, will now have to be submitted in eCTD format using the FTP server

Once a Sequence is uploaded the Applicant should QC their upload to ensure it is complete and as expected.
When the Applicant is ready for their application to be pushed to the automated processing, they need to add the trigger file ####-envelope.xml [where ####=Sequence Number]

The Applicant SHOULD NOT upload the trigger file together with the sequence as this will trigger the automation to take what is there, assuming that the upload is complete when it may not be

Once triggered, the automation will…

Validate the Sequence –

Result will be communicated to the Applicant immediately using the email addresses provided in the trigger file
Result will be communicated to the Portal to update status information immediately (starting in July when Portal goes live)

Transfer the sequence from the portal to the SAHPRA repository if validation is successful

It will be transferred to a “Failed” folder if validation fails where it will be deleted

Sequence is uploaded into the SAHPRA Evaluation System
The Portfolio Coordinator and Evaluation Coordinators are assigned based on the Submission Type designated in the trigger file
Starting in July, the status information will be relayed back to the Portal every time it is updated in the Evaluation System

Application Status
Submission Status
Sequence Statuses: Overall | Clinical | Inspectorate | N&S | Quality

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Information required by Portal – Trigger file creation

Occurrence	Constraint	Description
Single	Mandatory	Applicant/APIMF Holder
Single	Mandatory	Submitted by
Single	Mandatory	Application Type
Single	Mandatory	Application ID
Unique	Mandatory	INN
Unique	Mandatory	APIMF Number
Single	Mandatory	Submission Type
Single	Mandatory	Evaluation Path
Single	Mandatory	Submission Lead
Unique	Mandatory	Submission Number(s)
Unique	Mandatory	Sequence Type
Single	Mandatory	Sequence Description
Single	Mandatory	Sequence Date
Single	Mandatory	Sequence Number
Single	Mandatory	Related Sequence Number
Single	Mandatory	Contact Code
Single	Mandatory	Contact Name
Single	Mandatory	Contact Email(s)

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Application Defined Lists

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Submission Defined Lists

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Submission Defined Lists

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Sequence Defined List

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Contact Defined Lists

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ZA eCTD 3.0

Preparing your APIMF

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Regional Considerations – South Africa

eCTD or eSubmission (structured CTD format)
File Formats = PDF
Document Navigation Aids

Bookmarks
Hyperlinks
Document Title Pages – NOT REQUIRED

Previously, we only allowed PDF files to be submitted in the eCTD. All other files were provided in the Working Documents.

Often, these files were the files that were actually used by the evaluation but outside the eCTD, there was no file security via the MD5 Checksums
All source files will be provided together with the PDFs in the appropriate section

For files where no appropriate section existed in the past to provide a PDF, we have added section in the new structure

No more Working Documents will be submitted using the ZA eCTD 3.0 specification
Working Documents will be automatically extracted out of the eCTD and uploaded into the new SAHPRA Document Management System.

They will be locked, cannot be edited in the version they are imported as so that the original file is always maintained.
Edits, proposed changes will be done by SAHPRA in a new version

Document Navigation Requirements

Bookmarks are the most helpful navigation aids an applicant can provide.

They are always current with the document and do not get broken over time (internal bookmarks)
Any files with more than 5 pages that do not have bookmarks (some sections excluded) will cause a warning that should be explained in the Letter of Application

Hyperlink requirements have not changed for now

Reports generated by new evaluation system showing all hyperlinks created and their destinations

If insufficient hyperlinking has been done or only the bare minimum has been done, this could lead to rejection of the sequence in Technical Screening

Future reports are planned to REDUCE THE HYPERLINKING REQUIRED IN THE VALIDATION TEMPLATE and drastically reduce the size of the validation template.

Document Title Pages – Just a note… Document Title Pages in Electronic Applications just annoy the evaluator because when they open a file, instead of starting with the information they want, they have to click next page.

We are not saying you must remove Title Pages, it is up to you if you want your evaluator annoyed while reviewing your content ☺

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ZA eCTD 3.0 Validation Criteria

More Checks to make Requirements more Transparent and Evaluation more Efficient

Part of the overall change in systems at SAHPRA includes an advanced new Validation Tool which enables us to not only validate according to the published validation criteria but also generate internal reports to assist us in technical screening and evaluation

Reports like the one mentioned earlier that can help reduce the need for industry to spend countless hours hyperlinking the validation templates

Our new technology allows us to author our own profiles, to generate our own reports giving us the flexibility to analyse submissions further in ways defined internally to support the evaluation process
We have almost doubled our validation checks from just over 100 before to now just over 200.

We are taking a detailed look at deep life cycle operations that may cause complications 20 sequences down the line
We are making sure that even optional components like Study Tagging Files are valid if provided
We are looking at logical combinations of envelope information
We are checking document existence at a whole new level
We are making sure that bundled submissions are done so in ways that do not hinder our evaluation efficiencies

Let’s take a closer look at the new Validation Structure

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Overview of New Validation Structure

1 eCTD XML Backbones identification
2 Files/Folders
3 ICH Backbone
4 South African Regional
6 PDF Analysis

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Please refer to following guidelines

SAHPRA eCTD Specification 3.0
SAHPRA eSubmission Specification 3.0 (out for comment)
Document matrix – eCTD website