Pharmaceutical /Medicine/Drug/OTC registration in South Africa 

MOH –Ministry of Health

MOH Website- https://www.gov.za/t 

Regulatory Authority – South African Health Products Regulatory Authority

Regulatory Website – https://www.sahpra.org.za/

Local Authorized Representative Required-Yes

Drug Registration Process

Medicine applications for registration for humans are divided into the following types for the determination of fees and allocation to reviewers for evaluation:

1. Applications for new chemical entities that contain pre-clinical and clinical data proving the safety and effectiveness of the dosage form, indication(s), and dosing schedule.
2. Innovative product line extension applications and multisource/generic applications that cite clinical data to support the formulation’s safety and efficacy, as well as any indications or dose schedules.
3. Applications involving multiple sources, generic versions, and innovator line extensions, with comparative bioavailability and bioequivalence studies provided as evidence of efficacy.
4. Multisource/generic applications, innovator-line extension applications, and comparative dissolution studies that provide evidence of efficacy, and any other comparative studies that do the same. Other applications, such as liquids and solutions, that were not included above.
5. Biological medications: biosimilars and biopharmaceuticals.

1.Phase prior to submission

Pre-submission meeting: To go over the requirements, the submission procedure, and to ask any questions, it is advisable to arrange a pre-submission meeting with SAHPRA. Designate a local representative: In South Africa, non-resident businesses must designate a local representative.

2.Compiling the dossier

Create an extensive dossier with all the pertinent details regarding the medication, such as safety, effectiveness, and quality data. Verify that the dossier follows the guidelines for Common Technical Documents.

3.Submission of an Application

Send the documentation and application to SAHPRA. Usually, the submission is made electronically. Remit the necessary payments so that the application can be evaluated.

4.Examining and assessing

The application will be checked for completeness by SAHPRA.Experts thoroughly examine the data presented as part of the evaluation process to determine the drug’s safety, effectiveness, and quality.

5.Decision on Registration

SAHPRA will decide whether to register the medication based on the examination. A registration certificate is given out if the application is accepted.

6.After Approval Phase

The product may be advertised and sold in South Africa following approval. To keep an eye on a drug’s safety in the market, post-marketing surveillance and ongoing pharmacovigilance are crucial.

7.Renewing and Making Changes

Usually, registrations have an expiration date, and renewal requests must be made prior to the registration’s expiration. SAHPRA clearance is additionally needed for any alterations or modifications to the registered product.

Following screening, an evaluator from each appropriate SAHPRA unit (e.g., Clinical, Quality (Pharmaceutical and Analytical), Inspectorate, Names and Scheduling, for a new registration application) will be assigned to review the application. A senior evaluator will then peer evaluate each unit’s principal evaluation. If there is disagreement about the ultimate decision or unanswered questions, the application will be sent to an advisory committee for review. The goal of this redesigned procedure is to expedite the evaluation process by allocating the Advisory Committee’s time to more difficult evaluations and answers. Recommendations will be combined for final assessment and registration or denial by SAHPRA if an application passes evaluation.

Certification

The applicant will be invited to pre-fill the new registration certificate template once a new medicine application is suggested for registration. To pick up their new registration certificates, applicants will be called.