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.
Researchers must submit a completed application on predetermined dates and obtain proof of delivery. An application form must be accompanied by the prescribed fee. The proof of delivery, proof of payments and cover page must be sent to SAHPRA via email.
PROCESSING OF APPLICATION FOR PROTOCOL AMENDMENT AND ADDITIONAL SITES AND/INVESTIGATORS
Submit the application at SAHPRA reception
Obtain proof of delivery
Submit proof of delivery, cover letter, proof of payment as well as the full application to CTCAmendments@sahpra.org.za
Screening and allocation to Internal/external Reviewer
Response provided to Applicant – Approval or Non-approval
Clinical Trial Unit aim to process new application 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.
|Question||What are the form needed to be filled in order to apply for a clinical trial?|
|Answer||The CTF-1 must be filled. Download Here|
|Question||When can I submit a new clinical trial?|
|Answer||Submission dates are published annually on the SAHPRA website refer to Link- under Clinical Trial Committee Meeting and Submission Dates|
|Question||How much does it cost to apply for a new clinical trial?|
|Answer||Refer to Link for fees payable to SAHPRA|
|Question||What are the requirements for submitting a new clinical trial?|
|Answer||Refer to link under Electronic submission of clinical trial documents.|
|Question||What if I do not have the required documents to complete my submission before the closing date?|
|Answer||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.|
|Question||Where do I submit a new clinical trials submission?|
|Answer||These are submitted at the SAHPRA reception Building 38 CSIR (subject to change)|
|Question||How do I make sure that my hard copy application gets to the right place?|
|Answer||Upon receipt of application at the SAHPRA Reception an acknowledgement of receipt in the form of a stamp and signature will be issued.|
|Question||What should an acceptable Proof of Delivery look like?|
|Answer||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.|
|Question||Where can I deliver New clinical Trials on submission date after 12:00 on a Friday when reception is closed?|
|Answer||An official communication will be posted on the SAHPRA website|
|Question||Will you still accept new clinical trials if submitted after the due date?|
|Answer||No clinical trials will be accepted after the submission date|
|Question||How will I know if my application has been received and reviewed?|
|Answer||Upon review of an application SAHPRA will send an official letter
communicating the outcome and queries on a screening
|Question||What is the timeline for receipt of screening checklist?|
|Answer||15 working days after submission of the application|
|Question||What is the timeline for response of screening checklist?|
|Answer||7 working days after receipt of the screening review|
|Question||Where do I respond to SAHPRA recommendations?|
|Answer||Hardcopy responses must be sent to SAHPRA reception and e-
mailed to email@example.com
|Question||What should I attach when I respond to rejection screening
|Answer||No response is required the queries must be used as guidance to
prepare for a resubmission at the next review cycle.
|Question||What are the requirements for being a principal investigator or co-investigator?|
|Answer||The requirements for participating as an investigator are obtainable from link in the document titled Clinical Trial Investigators|
|Question||What are the basic requirements for a clinical trial sites to deal with emergencies?|
|Answer||The requirements for emergency procedures at clinical trial site are obtainable from link the document titled Emergency Procedures for Clinical trial sites.|
|Question||How do I submit a protocol amendment or an application for additional sites/investigators?|
|Answer||Refer to Link under Electronic submission of clinical trial documents|
|Question||What is expected timeline to receive the response after the submission of application for additional investigators, site and protocol amendment?|
|Answer||6 weeks following receipt of the application.|
|Question||How do I enquire regarding the application for additional sites/investigators and protocol amendment?|
|Answer||The applicant should email to:
E-mail address for New clinical trials application alert, Responses to new Clinical Trial applications and related queries: firstname.lastname@example.org
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: email@example.com
E-mail address for Notifications and related queries: firstname.lastname@example.org
E-mail address for Individual Patient Serious Adverse Events and related queries: email@example.com
E-mail address for SAHPRA Guidelines, forms and related queries: CTCGuidelines@sahpra.org.za