Clinical Trials in South Africa: A Comprehensive Overview

Nov 20, 2025 0

Clinical trials are essential for advancing medical science and improving healthcare outcomes. In South Africa, these trials are governed by a robust regulatory framework and ethical guidelines to ensure the safety and well-being of participants.

The Role of Novotech in South Africa

Novotech's presence in South Africa offers a strategic advantage for conducting clinical trials, providing access to a diverse pool of potential participants across various therapeutic areas. This local presence facilitates smooth communication and collaboration with local investigators, regulatory bodies, and healthcare establishments, ensuring efficient trial management and compliance. By operating locally, Novotech effectively navigates the regulatory landscape, expediting the approval process and ensuring adherence to compliance standards, ultimately accelerating clinical trial execution in South Africa.

By operating locally, Novotech can navigate the regulatory landscape effectively, expediting the approval process and ensuring adherence to compliance standards, ultimately accelerating the timeline for clinical trial execution in South Africa. This presence helps in smooth communication and collaboration with local investigators, regulatory bodies, and healthcare establishments, making trial management efficient and ensuring compliance. Novotech’ s presence in South Africa not only gives it a strategic advantage for conducting clinical trials but also allows access to a diverse pool of potential participants across various therapeutic areas.

Regulatory Framework

The South African Health Products Regulatory Authority (SAHPRA) is the regulatory authority overseeing medicines and clinical research, as well as medical devices and radiation safety. SAHPRA is responsible for clinical trial oversight, approval, and inspections in South Africa, granting permission for clinical trials to be conducted in accordance with the provisions of the Medicines and Related Substances Act (GRMRSA).

SAHPRA is an independent, state-owned entity responsible for:

The regulation of health products intended for human and animal use
The licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices; and radioactive nuclides
The conduct of clinical trials in a manner compatible with national medicines policy

SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting, and registering) all health products, including clinical trials, complementary medicines, medical devices, and in vitro diagnostics (IVDs). The Clinical Trial Committee (CTC) within the Clinical Trial Unit reviews clinical trial applications and bioequivalence studies for human participants and recommends approval of the conduct of clinical trials. SAHPRA also authorizes the importation of unregistered medicine for the purpose of conducting clinical trials.

SAHPRA is responsible for ensuring efficient, effective, and ethical evaluation or assessment of health products that meet defined standards of quality, safety, efficacy, and performance; ensuring that the process of evaluating or assessing and registering health products is transparent, fair, objective, and concluded in a timely fashion; ensuring periodic re-evaluation and monitoring of health products; and conducting announced and unannounced inspections.

Clinical Trial Review Process

The CTU of SAHPRA receives, processes, and evaluates clinical trial applications and any subsequent amendments for approval to conduct a study within South Africa. Researchers must submit a completed application and the prescribed fee on predetermined dates. Incomplete documentation or sub-standard submissions will be rejected, as will applications submitted without clinical trial insurance. Applicants are allowed a maximum of two rounds of queries to respond to, and if the responses are not satisfactory, the application will be rejected.

Clinical trial reviews will result in one of the following outcomes:

Category 1A: Approved; no items pending
Category 1B: Approved; ethics approval pending
Category 2A: Not approved; for approval by in-house evaluators, 1-2 or more items outstanding as deemed by the committee
Category 2B: Not approved; for approval by the original evaluator and in-house if a need arises
Category 3: Not approved; items outstanding to be discussed at the next CTC meeting
Category 4: Not approved; for referral for specialist opinion
Category 5: Not approved - technical/scientific deficiencies; applicant to resubmit for the next cycle
Category 6: Rejected due to administrative and technical items outstanding; applicant to resubmit for the next cycle

SAHPRA will also review clinical trial applications for evidence of plans to build capacity at each study site as well as enhancing research activities and skills of professionals from historically disadvantaged groups.

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Clinical Trial Application Fees

SAHPRA is authorized to collect fees for its various medicine regulatory functions. The fees for submitting a clinical trial application are as follows:

Type of Application	Fee (South African Rand - R)
Clinical trial application (safety and efficacy)	33,700
Clinical trial application (bioequivalence study)	31,700
Clinical trial application (postgraduate study) with pharmaceutical company involvement	11,200
Phase 4 clinical trial application and any other clinical trial application	5,100
Technical amendment applications	7,200
Administrative amendment applications	4,200

SAHPRA has initiated a process to phase in an electronic application system through various Application Portals that will create unique reference numbers for the application and relevant payment.

Ethical Considerations

Ethics committees (ECs) in South Africa are governed by the National Health Research Ethics Council (NHREC), a statutory body established under the National Health Act (NHA). NHREC determines guidelines for the functioning of ECs and registers and audits ECs, among other functions. NHREC gives direction on ethical issues relating to health and develops guidelines for the conduct of research involving humans and animals.

Every institution, health agency, and health establishment at which research is conducted must establish an EC or have access to an independent EC that is registered with the NHREC. Researchers without affiliation to an institution or organization with an EC should approach a registered EC to request it to review their health research protocols.

Ethics Committee Composition

An EC must consist of members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of all proposed research studies. ECs should be independent, multidisciplinary, multi-sectoral, and pluralistic. Membership should include diverse age groups, academic or professional ranks, ethnically and culturally diverse members, an appropriate mix of genders, lay persons, and researchers.

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EC membership should consist of:

A minimum of nine members with a quorum being a simple majority
At least one layperson
At least one member with knowledge of, and current experience in, the professional care, counseling, or health-related treatment of people
At least one member with professional training and experience in qualitative research methodologies
Members with professional training and experience in quantitative research methodologies
A member with expertise in biostatistics
A member with expertise in research ethics
At least one member who is legally qualified and has extensive knowledge of family law, health law, and research ethics

South African Regulatory Framework for Clinical Trials

Pan African Clinical Trials Registry (PACTR)

The Pan African Clinical Trials Registry has built a platform to register trials and improve transparency. All countries in Africa that participate in the African Vaccine Regulatory Forum have agreed to use the PACTR as their primary register.

Key aspects of the PACTR include:

Acceptance of prospective registration of interventional clinical trials
Open to all prospective registrants internationally or within specific countries in Africa
Collection and public display of the WHO Trial Registration Data Set
Endeavoring to keep registered information up-to-date with a reminder system
Ensuring the validity of registered data through contact with Responsible Registrants and documented Standard Operating Procedures (SOPs)
Maintaining a publicly accessible audit trail to track changes made to the WHO Trial Registration Data Set
Accessibility to the public at no charge, electronically searchable, and available in English

Globalization of Cancer Clinical Trials in Africa

Africa's research landscape is evolving due to economic development and the rising incidence of noncommunicable diseases like cancer. The participation of African countries in clinical trials is a proactive route to bringing innovative cancer therapies and functional infrastructure to the continent. Factors that have previously excluded Africa from clinical trials, such as low resources and limited expertise, are being addressed through collaborations with international organizations.

The African Organization for Research and Training in Cancer (AORTIC) met in Maputo, Mozambique, in November 2019 to discuss effective approaches to conducting cancer clinical trials in Africa and the opportunities that the continent provides as a hub for cancer clinical trials.

Initiatives to improve cancer clinical trials in Africa include:

Training programs: The African Research Group for Oncology (ARGO) organized training programs on clinical trials for early career researchers.
Consortiums: The formation of consortiums in Africa will offer the ability to rapidly recruit many patients into a trial while also allowing for collaboration among African clinical trialists.
Biobanks: Few biobanks are emerging, and these include H3A biorepositories in Uganda, Stellenbosch, and Cape Town, and 54 Gene and ARGO biobanks in Nigeria.

Ensuring Access and Ethical Conduct

The South African government's participation in clinical trials is crucial for evaluating the suitability of vaccines and treatments in its diverse patient population. It is important for the government to negotiate shrewdly for access to these medicines, ensuring that the benefits of the research are available to the people of South Africa.

Pharmaceutical corporations have an ethical duty to ensure access to the medical products being trialled for participants but also to the general population given the public investments and resources injected by taxpayers to enable these research trials. History, however, has taught us that we cannot rely on the generosity of pharma corporations.

The South African National Clinical Trials Register (SANCTR)

The South African National Clinical Trials Register (SANCTR) provides the public with updated information on clinical trials on human participants being conducted in South Africa. The Register provides you with information on a trials purpose; who can participate, where the trial is located, and contact details.