Training Manual Update Logs

Internal Release Notes

This page tracks only significant changes made to the SAHPRA Engagement Portal that apply to the internal SAHPRA team.

2.8.0 (2026-08-31)

General

  • The signing page for signatories has been improved for all application types. When signing a document, the signer now has full context on the page: a View Application button to view the full application, the application timeline, and all recommendations from the previous review and screening steps, including who made each recommendation.
  • Documents generated for Licensing and Post-Advertising Review applications now include a QR code that can be scanned to verify the document’s authenticity on a public verification page.

Clinical Trials

  • Implemented the new Review Report feature:
    • Review question responses now automatically build a summary report for the application. Each review question pulls the applicant’s linked response(s) in as an editable draft, which the reviewer can summarise or adjust where needed.
    • The generated report is available during the meeting stage and is visible to meeting invitees once they have confirmed their attendance and completed their conflict of interest declaration.
    • The report can also be downloaded as a PDF document.
    • Updated the review questions to match the provided review templates, so that all questions related to the review cycle are included in the report.
  • Added the Coordinators button to the Coordinator Dashboard for all coordinators, allowing coordinators to change the assigned coordinators for an application (previously only available to the Super Admin).
  • Added the Assigned Cycle as a selectable field for the CTF1 report in the report builder.
  • Trial site documents are now also available to be reviewed during Administrative and Technical Screening. Previously these documents did not appear in the right-hand documents panel while screening.
  • Added Involved Evaluators to Administrative and Technical Screening, allowing the screener to capture all evaluators involved in the application. The captured evaluators are visible on the coordinator’s application overview once screening is completed, and can be added to reports via the report builder.
  • Limited the allowed document types to PDF only for clinical trial applications.
  • Improved the usability of the review pane:
    • The review pane now stays in view and scrolls independently from the application, so the review questions and documents remain accessible while working through the application.
    • Completed review questions are now clearly marked when working within the individual sections.
    • Leaving a comment on a review question now opens in a full pop-up view, making comments easier to write and save.
    • Rejecting a review question now requires a comment before the rejection is saved.
    • Screening progress is now tracked across the entire application instead of per section.
  • The review process can now continue while an application is queried, instead of pausing until the query has been resolved.

Licensing Applications

  • Implemented the full Licensing review flow for all 11 licensing application types, from the initial payment review, through screening, review and inspections, to the final sign-off and the document fee payment at the end:
    • The inspection now runs as part of the application workflow, and the completed inspection results and report are visible on the review steps that follow the inspection.
    • The inspection includes an activities checklist listing the licence activities the applicant applied for. The inspector approves or rejects each applied-for activity, designated review steps can amend these decisions, and the final decisions are reflected on the licence document.
    • On approval, the licence document and a signed approval letter are generated and issued to the applicant. On refusal, a refusal letter is issued instead.

Advertising

  • Implemented the internal review flow for the new Post-Advertising Review application type, covering the application from submission through to the final outcome.
  • Review recommendations and the final outcome of an application are now configurable per workflow step: each recommendation can be given its own title and description, and the recommendation marked as the final decision determines the resulting application status.

Medicines Registry

  • The Medicines Registry has been released on a trial basis with select organisations, matching SAHPRA’s medicines register against the portal data and guiding applicants through completing their product data. Further updates will follow as the trial progresses.
  • Alongside the registry trial, the new Support Tickets feature is available to the participating organisations. Applicants can log support tickets on the portal, which the support team manages from the new Support Tickets queue, with escalation and notifications for tickets nearing their response deadline. The feature will be rolled out to all users at a later date, alongside the wider Medicines Registry release.

Section 21 Applications

  • The internal team can now upload additional supporting documents to a Section 21 application at any time, from the application’s supporting documents section.

Health Product Applications

  • Updated the Variation Summary document to the required SAHPRA specifications.
  • When uploading a letter, the date the letter was issued can now be captured, so the letter reflects the correct issue date. A letter’s date can also be corrected afterwards using the new Edit Date option on the application’s documents.
2.7.2 (2026-08-19)

Section 21 Applications

  • Added a 100 entries per page option to the My Reviews page.
  • The application number is now always visible on all review screens, including the final review screen and the screening summary page.
  • Reviewer recommendations are now shown on the application timeline, with approvals displayed in green and rejections in red.
  • Auto-rejected applications now properly close out the application process — no further review actions are possible on an auto-rejected application, and an auto-reject indicator on the application status makes these applications easy to identify. The auto-reject flag is also available in the report builder.
  • The Submitted date column now reflects the payment approved date, as a Section 21 application is classified as submitted once its payment has been approved.
  • UI enhancements:
    • Completed review questions are now clearly marked.
    • The section headings have been reverted to the previous styling, and the timeline is accessible from the dashboard again.
  • The My Signatures page now displays correctly whether or not you have pending signatures (previously it only appeared after a hard refresh), and filters have been added to the page.
  • The Internal User Manual is now available on internal accounts, under Administration in the left-hand navigation.
  • Resolved an issue where dashboard data did not appear correctly: individual applicants now display as Individual in the organisation column, and the INN and Applicant columns now populate as expected.
2.7.1 (2026-08-05)

Clinical Trials & Section 21 Applications

  • Updated the Coordinator Dashboard to only display applications that require action from the internal team. Applications awaiting payment are no longer listed, and applications appear from Payment Submitted onwards.

General

  • Resolved an issue in the new Report Builder where the column data did not populate when generating a report.
2.7.0 (2026-07-31)

Section 21 Applications

  • Version 2 of Section 21 has been released, which includes the following improvements:
    • An enhanced user interface.
    • Compulsory capturing of the INN/Active Ingredient Name.
    • Improved Reauthorisation administration.
  • Implemented a new Section 21 Coordinator Dashboard that provides a full overview of each application and where it currently sits in the review progress.
    • Any Section 21 reviewer can now reset an application from the Section 21 Coordinator Dashboard.
  • Updated the review process to allow two reviewers to review both Named Patient and Multi-Patient applications at the same time. Once one reviewer has completed a review for an application, the other reviewer no longer needs to review that same application.
  • Implemented a new review flow that allows more than one branch for the review of an application, determined by the Senior Manager review tags selected on the Administrative Screening and Review stage:
    • When the Administrative Screener and Reviewer selects one of the Unit Manager/Senior Manager review tags, the application requires review by both a Unit Manager and a Senior Manager.
    • When no tags are selected, only a Unit Manager needs to review the application after the Administrative Screener and Reviewer.
  • Updated the review page to include additional columns, such as the INN and Active Ingredient columns, to identify an application more easily when reviewing.
  • Added a Queried tab and a Query Resubmission tab to the review page to indicate applications that have been resubmitted after a query, and to allow filtering on them separately.
  • Review questions are now linked to the application responses. When a review question is selected, the related application question is loaded into view and both are highlighted.
  • Added Admin tags, allowing a tag to be added to an application while reviewing. Reports can now be filtered on specific tags to return only the applications linked to that Admin tag.
  • Improved the Outcome Letter generation. The Outcome Letter no longer needs to be downloaded and re-uploaded as confirmation of a signature. The confirmation is now built in, where the signatory enters their Engagement Portal profile password to validate their signature.
  • Added an additional reason for rejection to indicate no response from a queried applicant.
  • Queried applications now auto-reject if the applicant does not respond within three working days, and an auto-rejection document is uploaded to that application.
  • Updated the Application Timeline so that the Reauthorisation timeline no longer mixes with the original application’s timeline when the application is a Reauthorisation.
  • Applied the required changes, such as the pricing updates, to Multi-Patient applications as well as Named Patient applications.
  • Limited the Payments Dashboard to only Section 21 applications when a Section 21 internal user reviews the payment for an application.
  • Improved form rule enforcement, so that fields which previously could be left blank are now correctly enforced as required.
2.6.0 (2026-07-05)

Clinical Trials

  • Updated the Coordinator Dashboard to allow selecting cycles for each application.
  • Updated the Coordinator Dashboard to include the application status and the protocol number for each application.
  • The My Reviews page now also includes the application status and the protocol number.
  • Resolved an issue where certain application information did not display correctly.
2.5.7 (2026-06-23)

Clinical Trials

  • Added per-section comments to the Admin Screening step, allowing screeners to leave a comment on each section.
2.5.6 (2026-06-23)

General

  • Added a Company filter on the applications dashboard to filter applications by company.
2.5.3 (2026-06-23)

Clinical Trials

  • Implemented the Scientific Review flow, where a primary reviewer can be assigned to do a scientific review and can specify whether an additional reviewer is required to review the application.
  • The secondary/next reviewer can now see the previous reviewer’s review responses when making their decision on the review.
2.5.2 (2026-06-17)

Clinical Trials

  • Added the ability for reviewers to view queries on clinical trial applications.
  • Added a new audit PDF function that provides the full current progress of an application, accessible by the coordinator.
  • Resolved an issue where certain review questions did not show correctly.
2.5.1 (2026-06-15)

General

  • Added a filter to only view payments and applications for the application types you are linked to.
2.4.0 (2026-06-08)

General

  • Updated user roles to provide access to users based on the unit they are currently in.

Clinical Trials

  • Updated the Meetings section to better navigate between the application and the meeting.
  • Meetings now allow viewing the full application while within a meeting.
2.3.5 (2026-05-26)

Clinical Trials

  • Improved the coordinator page and workflow to allow multiple coordinators to be assigned to one application.
  • Resolved an issue with the Administrative Screening and Technical Screening steps where responses did not load correctly.
2.3.1 (2026-05-21)

General

  • Implemented a new Report Builder where custom reports can be created.

Clinical Trials

  • Resolved an issue where not all applications were showing on the Coordinator Dashboard page.

Section 21 Applications

  • Improved the search for applications on the Section 21 review page.
2.2.4 (2026-04-24)

Clinical Trials

  • Resolved issues with form validations for clinical trial applications.
2.2.2 (2026-04-24)

Clinical Trials

  • Improved the linking of Trial Sites to clinical trial applications, resolving issues where data went missing or did not display correctly.
2.2.1 (2026-04-17)

Clinical Trials

  • Updated the audit log to include all processes for clinical trials.
2.2.0 (2026-04-17)

General

  • Updated the Notification Centre.

Clinical Trials

  • Applications now lock form submissions once they have been submitted.
2.0.0 (2026-03-31)

Clinical Trials

  • Version 2 of the Engagement Portal has been released.
  • Implemented the basic structure for reviewing and workflow setup for clinical trials:
    • Implemented the Coordinator Dashboard for clinical trial applications, where a coordinator can view the progress of applications for reviewing purposes once they are submitted by applicants.
    • Implemented the review structure for clinical trial applications, where reviewers can be assigned to a specific review and are provided with a list of review questions to respond to.
1.7.4 (2025-11-20)

Health Product Applications

  • Refined the MetaSync integration to ensure that only required data is correctly captured and synced to the portal.
  • Added the Overall Evaluation stream option to the list of available evaluation streams when querying a sequence.
  • Implemented the admin side functionality for the Change Request feature, to allow for reviewing and approving change on the API Dashboard.
  • Implemented the ability to manually generate a Variation Summary for any applicable submission for an application on the API Dashboard.
1.7.3 (2025-10-20)

Health Product Applications

  • Added the ability to search for an application using any Application Number on the API dashboard.
  • Added the ability to indicate “0” or “0.00” when disputing a payment on the Payments Dashboard.
  • Implemented a tool to complete any TOA that the process was started before portal release, and needs to be completed on the portal.
  • Updated the query upload functionality to align with docuBridge, by including the new Unit selection dropdown, and all additional document types.
  • Updated all reports to align with SAHPRA requirements.
  • Implemented all requested dashboards with the appropriate permissions.
1.7.1 (2025-10-06)

Health Product Applications

  • Grouped Variations now require approval from the HPA Unit. Please refer to the Grouped Variations guide for a guide on how to review and approve a Grouped Variation.
  • Updated the Query Letter upload guide to reflect the new Query Letter upload process. Please refer to the Query Letter upload guide for details.
1.7.0 (2025-09-19)

Health Product Applications

  • Added the ability for MetaSync to capture the related sequence of any sequence being synced to the portal.
  • Added a restriction to only allow users to select a Master strength when creating a Clone or Replica variation.
  • Resolved an issue with applications showing Sub Type Not Listed
  • Resolved an issue when trying to update Submission Data on a legacy application that did not work when the submission type was NULL
  • Updated how the portal handles identifying the Application Submission Type when it is not listed first on the application
1.6.0.1 (2025-09-17)

General

  • Resolved an issue where Disputed Payments did not allow applicants to submit a new proof of payment.

Section 21 Reviewing

  • Fixed an issue where the INN information would be lost when reviewing an application
1.6.0 (2025-08-29)

Health Product Applications

  • Resolved an issue with MetaSync data generating duplicate Submission numbers for HPA Applications
  • Introduced a new feature to allow internal users to upload documents to an HPA Application. This can be done from the new Documents tab on the Application View page.

General

  • Reworked all Application ID generation to use a reservation system to ensure that the Application ID is unique.
  • Resolved an issue when trying to assign a user to a unit from the Unit management dashboard.
1.5.10 (2025-08-21)

Health Product Application

  • Updated how Draft Applications strengths are loaded to increase system stability and viewing capabilities.
  • Updated the Health Checker to identify HPA Application that are missing application data, and then automatically set the application to a Legacy state.
1.5.9 (2025-08-13)

Health Product Application

  • Added the ability to Transfer an application to a company on the API Dashboard
  • Added the ability to change the Application ID on the API Dashboard
1.5.8 (2025-08-08)

Health Product Application

  • Updated the Health Checker to optionally send an email to the applicant if changes are made to the application.
  • Updated the Original Submission Type popup to list only the applicable Submission Types for the application.
1.5.7 (2025-08-07)

Health Product Application

  • Fixed an issue with the Notification email rendering accessible on the API Dashboard
1.5.6 (2025-08-04)

General

  • Added the ability to send HTML emails from the API Dashboard to all users on the portal
  • Created a Health Checker tool to clean up HPA Application data that was not correctly captured with MetaSync integration or legacy data
1.5.5 (2025-07-28)

Health Product Application

  • Added the ability to set the Registration Date for an application number when setting approval for the application

Section 21

  • Updated section headings when Viewing or Reviewing an application from the My Reviews dashboard

General

  • Fixed an issue when trying to edit an Organisation from the Organisation Management dashboard
  • Added the ability to sort the Audit logs by Application ID when viewing the them on the api dashboard
  • Fixed an issue when trying to resend verification emails to users from the Admin Tools dashboard
  • Improved metaSync mapping for:
    • Application Type
    • Legacy Applications
    • HPA Sequence’s related sequences
1.5.4 (2025-07-18)

Section 21

  • Updated the header and footer of the Outcome Letter as required by SAHPRA
  • Improved the Section 21 Report for better analysis of the data
1.5.2 (2025-07-11)

HPA

  • Improved linking of data between the portal and MetaSync

Section 21 Reviewing

  • Clicking the back button when on the Overview page of an application will now take you back to the application reviewing screen
1.5.1 (2025-07-08)

General

  • Revised and improved portal and email notifications. This enhancement will be implemented across three phases, with phase one now complete
  • Improved the Payments dashboard to better indicate the purpose of payment entries
  • Fixed an issue where some payments would incorrectly display a R0 amount

Section 21 Reviewing

  • Fixed an issue where the INN information would be lost when reviewing an application
1.5.0 (2025-06-30)

General

  • Syncing and processing of DocuBridge data via MetaSyn Out to the Engagement Portal
1.4.1 (2025-06-18)

General

  • Fixed issue with missing dash (“-”) and empty payment entries.

Section 21

  • Fixed filters in the Section 21 Applications Report.
  • Added additional document selector when sending review comments back to applicants.
  • User management updated: Ability to remove users from a unit and only Unit managers have access to this feature.

HPA

  • Enhanced legacy data correction and additional metadata processing for MetaSync integration.
1.4.0 (2025-06-09)

Section 21 Applications

  • Fixed an issue where the Application Timeline on a review was displaying incorrect
  • When Viewing or Reviewing and application on the My Reviews dashboard, the application will open in a new tab
  • Updated the Outcome Letter to include the new signature provided by the SAHPRA Section 21 team

General

  • Fixed Reports generation that did not function
1.3.0 (2025-05-22)
  • Optimised the Application Management Dashboard to load entries faster
  • Reviewers for Section 21 Applications can now attach documents to an application when reviewing an application.
  • Users linked to a Unit will now be able to view applications related to them on the Application Management Dashboard
  • Added proper page handling when loading a 404 error page
1.2.3 (2025-05-16)
  • Optimised the Payments Dashboard to load entries faster
  • Optimised the Review Dashboard to load entries faster
  • Added the Application Timeline when viewing the application on the Review Dashboard
1.2.2 (2025-05-13)
  • Added a layer of security to documents. Links to documents will now not be shareable
1.2.0 (2025-05-10)
  • Improved the Admin Tools feature
  • Various performance improvements
1.1.0 (2025-04-30)
  • Improved the Admin Tools feature to show additional summaries for Support and include total users, amount of applications per type and status and sub divisions
Improvements (2025-04-02 to 2025-04-29)
  • Updated columns to include additional information for an application on the Application Management dashboard
  • Updated columns to include additional information for an application on the Payments dashboard
  • Updated columns to include additional information for an application on the My Reviews * Added an Admin Tools page for a System Administrator
  • Updated auto-generation of Application Numbers to generate from 61xxxx instead of using the CAH format
1.0.0 (2025-04-01)
  • Initial release of the SAHPRA Engagement Portal with core functionality.

How to Stay Updated

  • Check this page regularly for the latest portal updates
  • Contact SAHPRA support for specific update inquiries