Digital Transformation

SAHPRA’s digital transformation is a priority for the organisation as our focus is on building capabilities and systems that will allow the institution to be more agile, innovative, streamlined, and efficient in the delivery of its mandate.

At the centre of this digitisation will be intuitive self -service customer portals for the end-user, as well as intelligent internal management and review systems to streamline the entire regulatory process. Underpinned by a data analytics tool the enables real-time reporting and insights.

The ICT Strategic Roadmap

The Information Technology Strategic Plan sets out a five-year strategic direction for Information and Communication Technology (ICT) in response to SAHPRA’s key strategic objectives which include the strengthening of Information and Communication Technology and the Digital Transformation of SAHPRA’s business processes.

The 5 ICT Strategic Principles

Principle 1

Meet Industry and Stakeholder Expectations – SAHPRA strives to be an innovative organisation that can consistently and reliably respond to the needs and expectations of its stakeholders through the implementation of user-centric solutions that service those user needs.

Principle 2

Digitally transform and automate business processes – The development of an Integrated Regulatory Information Management System will be a flagship project for the digital transformation of SAHPRA, bringing all regulatory processes onto one platform with built-in automation, intelligence, and robust reporting capabilities

Principle 3

Establishment of Reliable Enterprise ICT Infrastructure – As a new entity, SAHPRA requires significant investment into the design and deployment of IT infrastructure that meets the performance and capacity standards to reach its operational requirements.

Principle 4

Enhance data and information security – Cybersecurity is an ever-evolving aspect of any information technology strategy. While bringing important opportunities, the consolidation of systems leads to a greater attack surface that requires enhanced security measures to minimise risks. For a regulator such as SAHPRA, ensuring confidentiality, integrity and availability of internal and stakeholder information is critical in maintaining regulatory and reputational integrity.

Principle 5

Deliver Value enabled by appropriate ICT Governance practices and frameworks – Strong and effective corporate governance of ICT will cultivate a culture of strategic ownership and control over IT direction and investment, thereby ensuring that there is alignment between IT priorities and expenditure and the organization.

Digitisation Roadmap

Comments from the COO

One of the Strategic Levers for the organization is to successfully digitilise our business processes and create efficiencies that will enable the organisation to drive improved service delivery, improved turn-around times and improved access to real-time information. This will enable sound decision making, keeping our various stakeholder informed and rapidly provide pertinent information when and where required. The Information Communications and Technology unit has been working closely with our internal stakeholders to improve the digital execution maturity of the organization, to capture the user requirements specifications and identify suitable digital solutions to the needs of the organisation. We have managed to establish sound network and connectivity infrastructure, collaborations and communications platforms and will be focusing immense effort and resource in 2023 and 2024 periods to implement a number of software tools for core operational processes and will be engaging our industry stakeholders during the implementation processes to keep you informed, and ensure we have training sessions available to enable our external users to use the tools optimally in order to derive maximum benefit for all parties involved.

Milestones achieved so far!

For use by registered users to log tasks and queries to the various SAHPRA units.

Provides healthcare literacy information to both healthcare professionals and health product consumers with a guide to all SAHPRA registered over-the counter (OTC) medicines that are available in South Africa without a doctor’s prescription.

Process digitalised, allowing SAHPRA team and stakeholder to mange applications and feedback to applicants efficiently.

Process digitalised

Tool launched for internal users 1 July 2023

Digitalised process in Pilot phase

Coming Soon!

The SAHPRA Chatbot is an innovative and interactive virtual assistant designed to provide reliable and up-to-date information about health products, regulations, and related queries. Powered by cutting-edge AI technology, the chatbot aims to enhance public engagement, improve accessibility to essential health information, and promote transparency within the regulatory process.

For health product applications – this tool will manage the a) document management, b) case/life-cycle management, c) application evaluation tool d) real-time health-product register reflecting approved variation changes e) resource management and f) relevant management reporting.

(Sept 2023 to June 2024)

Fhe platform will allow applicants to submit their applications and the required information in the online tool – the tool will enable a) online applications, b) e-document management, c) trial management d) management reporting, e) study amendments f) report submissions g) notifications and alerts management.

(June 2023 to Oct 2023)

For the management of import and export applications for controlled substance – this tool will provide a) a webservice portal where applicants may log their applications to the regulator, b) internal review and processing workflows c) notifications to INCB control systems network d) permit documentation management e) notification systems f) real-time access for border technicians/Port Health Users/SARS users to approved permits – with details around products, quantities, g) estimates management, h) INCB annual reporting requirements.

(Oct 2023 to March 2024)

All digital systems data relevant for performance and management reporting will be collated in a data warehouse and the business analytics platform will allow various management reports to be generated and relevant information can be shared from here to the website (i.e. licensed establishment listings, health product registers, performance metrics etc.) and information required by stakeholders such as NDOH, SARS etc (e.g. health product register, license holders etc.)

(Oct 2023 to Dec 2024)

to allow for new applicants to submit applications for inter alia new licenses, for S21 applications etc. The portal will also allow for a payment gateway option.

(Oct 2023 to Dec 2024)

The To-Do List!

Pharmacovigilance Signal Detection and Case Management platform

Market research and User Requirement Specification (URS) compilation to be completed

Batch Tracking Tool

This is linked to Health Product Master data management and will allow health product consumers to verify authenticity of products and lots available in authorised health product supply points.