The regulatory functions of South Africa are Registration, Quality Control, Inspections, Licensing, Pharmacovigilance, Clinical Trials, and Market Surveillance. SAHPRA is currently using a new and re-engineered system of medicine regulation. SAHPRA conducts GMP inspections, inspection of Clinical Trial Facilities, and inspection of Distribution channels. The Authority licenses facilities and currently cannabis for medicinal purposes.
The Quality Control department investigates any complaint that is reported and tests samples in the quality control labs. The Quality Control department also handles the testing of vaccines. Vaccines need to be tested before they are administered to patients.

To register a medicine, an applicant has to submit a dossier to the regulatory authority. They need to compile the dossiers in line with the requirements for registration. The dossiers are submitted via CTD or E-CTD format. Dossiers can be submitted on a flash drive or CD which and then uploaded unto SAHPRA’s system. After submission, there has to be a business validation and a technical validation of the application.
•      The Business validation is to ensure that the dossier is complete
•      The Technical validation ensures that everything in the dossier is compliant with the guidelines.
There are two different reports that will be generated from the validation processes. The documents are then handed over to reviewers. Reviewers assess the dossier. There are different reviewers for each required CTD module of the dossiers. The Inspectorate handles issues of Good Manufacturing Practices compliance

The Authority checks for illegal products on the market and counterfeits. SAHPRA is a member of a committee for regulatory authorities to share information on safety alerts and recalls, then communicate information to the public, warning them of safety issues relating to medicines.
If the site has not been inspected before, the authority will draw up an inspection plan. They review all documentation and guidelines before going to the site. The applicant must also be notified with the date of inspection. The inspectors enter data and comments electronically on site. Have a meeting to discuss observations made. Then an inspection report is drafted. There is an in-house peer review system that reviews all documentation, which will be used to peer-review the report.
This report is then sent to the applicant to check for deficiencies. The applicant is supposed to respond with the necessary corrections, which will be evaluated again by the inspectors. Then another inspection report is generated and sent to be approved. If the application proves to be GMP positive, the GMP database is updated with the information. The GMP reports are then compiled for registration.
For a medicine to qualify for registration, it needs to be GMP certified, have an approved name and schedule, have a positive quality report and a Patient Information Leaflet.
SAHPRA is a member of Pharmaceutical International Corporate Scheme (PICS). If a site has been inspected by PICS member, SAHPRA conducts a desk review.

For clinical trials to be conducted, an applicant has to submit a clinical trial application form. The applicant needs the form, the protocol and supporting documents. This will be sent to the Clinical Trial unit for administrative and technical screening. This is to ensure completeness of the document. The document can be categorized under the following depending on the severity of issues with the document:
•      Category 1A: The document is approved out rightly. No issues were raised
•      Category 1B: The document checks all the boxes but needs approval from the ethics committee.
•      Category 2A: There are administrative issues with the document.
•      Category 2B: The issues in the application has to be evaluated against the applicant’s responses by the original reviewer. It does not need to go to the peer review committee.
•      Category 3: The are major deficiencies in the document. After responses have been evaluated by the initial reviewer it needs to be reviewed again by a team of experts.
•      Category 4: This is for applications of a new molecule that need the expertise of an individual outside the technical advisory team.
•      Category 5: The document has serious deficiencies and may have to be resubmitted.
SAHPRA has a software for clinical trials named the Clinical Trials database. However, it was not effective since it could not handle large documents and they are hoping to get a better system for this regulatory function.

SAHPRA uses Vigiflow software tool to report adverse drug reactions. There is a platform on the National Department of Health Website that allows health care professionals to report ADRs. The document is generated in pdf form. SAHPRA had an ADR Database created just for the authority. The only disadvantage was that when information had to be exported from the database to Vigiflow, some of the data gets trimmed and is lost.