The Clinical Trial Unit of the South African Health Products Regulatory Authority (SAHPRA) provides legal framework for the review of clinical trials and Bioequivalence studies for human participants and recommends approval of the conduct of clinical trials. The unit receives, processes and evaluates the applications from applicants (industry, academia and investigators) for approval to conduct the study within South Africa (SA). The unit also provide for authorization for the importation of unregistered medicine for the purpose of conducting clinical trials. Any amendments required during the conduct of the study, must be approved by SAHPRA.
Medicines and Related Substance Act, Act 101 of 1965, provides for the legislative framework for access to unregistered medicines, it is enabled by Section 21 of the Act as amended: Authority may authorize sale of unregistered medicines for purpose of conducting clinical trials.
South African Good Clinical Practice Guidelines (SA GCP) provide researchers and other interested parties with clearly articulated standards of GCP in locally conducted research that address the local realities and contexts, to ensure that clinical trials involving South African human participants are designed and conducted according to local requirements as well as according to the sound scientific and ethical standards within the accepted framework for good clinical practice.
SAPRA has developed several guidelines for researchers in order to ensure that human participants are protected and are able to derive benefits from participating in clinical trials conducted in South Africa.
Clinical Trial Unit aim to process new applications and issue checklist within 3 weeks of receipt. The Clinical Trial Committee recommendations would be sent within 10 weeks of submission due date. There are cases where this turnaround time might be prolonged i.e. unfamiliar investigational product which may be referred to external reviewers or other committees of SAHPRA for input.
The timeline to receive the response after the submission of application for additional investigators, site(s) and protocol amendment is about 6 weeks following receipt of the application. The applicants should make use of the electronic submission process.
The applicant should ensure that the documentation required for submission of a clinical trial is complete as incomplete or sub-standard applications will be rejected.
These are submitted at the SAHPRA reception Building 38 CSIR (subject to change)
Upon receipt of application at the SAHPRA Reception an acknowledgement of receipt in the form of a stamp and signature will be issued.
The waybill from a courier company does not suffice. SAHPRA’s Clinical Trials Unit requires a document, referred to as the ‘stamp page’, which includes the SAHPRA trial reference number, protocol number and study title to reflect on it. This document will then be date-stamped and signed by our Administrative department and returned to the sender as proof.
An official communication will be posted on the SAHPRA website
No clinical trials will be accepted after the submission date
Upon review of an application SAHPRA will send an official letter communicating the outcome and queries on a screening checklist.
15 working days after submission of the application
7 working days after receipt of the screening review
Hardcopy responses must be sent to SAHPRA reception and e-mailed to firstname.lastname@example.org
No response is required the queries must be used as guidance to prepare for a resubmission at the next review cycle.
Clinical trials reviews can be classified as follows:
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, the next cycle.
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
10 working days after clinical trial committee meeting
7 working days after receipt of comments
Refer to Link under Electronic submission of clinical trial documents
6 weeks following receipt of the application.
E-mail address for New clinical trials application alert, Responses to new Clinical Trial applications and related queries:
E-mail address for Protocol amendments, responses to amendments and related queries: email@example.com
E-mail address for Additional Investigators & Sites, responses to additional and related queries: firstname.lastname@example.org
E-mail address for Bioequivalence studies, BE amendments, responses to BE studies and related queries:
E-mail address for Notifications and related queries:
E-mail address for Individual Patient Serious Adverse Events and related queries:
E-mail address for SAHPRA Guidelines, forms and related queries: