1. PURPOSE:

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.

2. LEGISLATIVE FRAMEWORK:

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.

3. PROCESSING CLINICAL TRIALS APPLICATIONS:

    • 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.
      • SAHPRA NEW CLINICAL TRIALS PROCESS
      • PRE APPROVAL
      • POST APPROVAL
      • PROCESSING OF APPLICATION FOR PROTOCOL AMENDMENT AND ADDITIONAL SITES AND/INVESTIGATORS

SAHPRA NEW CLINICAL TRIALS PROCESS / PRE APPROVAL

4. TURNAROUND TIME FOR RESPONSE TO A CLINICAL TRIAL APPLICATION:

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.

8. FREQUENTLY ASKED QUESTIONS FOR CLINICAL TRIALS SUBMISSION OF NEW CLINICAL TRIALS (PRE APPROVED PROCESS)

WHAT ARE THE FORMS NEEDED TO BE FILLED IN ORDER TO APPLY FOR A CLINICAL TRIAL?

The CTF-1 must be filled and is obtainable from Link Clinical Trial Application Form

WHEN CAN I SUBMIT A NEW CLINICAL TRIAL?

Submission dates are published annually on the SAHPRA website refer to Link under Clinical Trial Committee Meeting and Submission Dates

HOW MUCH DOES IT COST TO APPLY FOR A NEW CLINICAL TRIAL?

WHAT ARE THE REQUIREMENTS FOR SUBMITTING A NEW CLINICAL TRIAL?

Refer to link under Electronic submission of clinical trial documents.

WHAT IF I DO NOT HAVE THE REQUIRED DOCUMENTS TO COMPLETE MY SUBMISSION BEFORE THE CLOSING DATE?

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.

WHERE DO I SUBMIT A NEW CLINICAL TRIALS SUBMISSION?

These are submitted at the SAHPRA reception Building 38 CSIR (subject to change)

HOW DO I MAKE SURE THAT MY HARD COPY APPLICATION GETS TO THE RIGHT PLACE?

Upon receipt of application at the SAHPRA Reception an acknowledgement of receipt in the form of a stamp and signature will be issued.

WHAT SHOULD AN ACCEPTABLE PROOF OF DELIVERY LOOK LIKE?

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.

WHERE CAN I DELIVER NEW CLINICAL TRIALS ON SUBMISSION DATE AFTER 12:00 ON A FRIDAY WHEN RECEPTION IS CLOSED?

An official communication will be posted on the SAHPRA website

WILL YOU STILL ACCEPT NEW CLINICAL TRIALS IF SUBMITTED AFTER THE DUE DATE?

No clinical trials will be accepted after the submission date

REVIEW OF CLINICAL TRIALS (preliminary screening)

HOW WILL I KNOW IF MY APPLICATION HAS BEEN RECEIVED AND REVIEWED?

Upon review of an application SAHPRA will send an official letter communicating the outcome and queries on a screening checklist.

WHAT IS THE TIMELINE FOE RECEIPT OF SCREENING CHECKLIST?

15 working days after submission of the application

WHAT IS THE TIMELINE FOR RESPONSE OF SCREENING CHECKLIST?

7 working days after receipt  of the screening review

WHERE DO I RESPOND TO SAHPRA RECOMMENDATIONS?

Hardcopy responses must be sent to SAHPRA reception and e-mailed to ctcresponses@sahpra.org.za

WHAT SHOULD I ATTACH WHEN I RESPOND TO REJECTION SCREENING OUTCOME?

No response is required the queries must be used as guidance to prepare for a resubmission at the next review cycle.

REVIEW OF CLINICAL TRIALS (Expert committee review)

HOW OFTEN DOES THIS COMMITTEE SIT TO DISCUSS APPLICATIONS?

CTC dates are published annually on the SAHPRA website refer to link under Clinical Trial Committee Meeting and Submission Dates

WHAT ARE THE POSSIBLE OUTCOMES OF A CLINICAL TRIAL REVIEW?

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

WHAT IS THE EXPECTED TIMELINE FOR RESPONSE FROM CLINICAL TRIAL COMMITTEE REVIEW?

10 working days after clinical trial committee meeting

WHAT IS THE TIMELINE FOR SUBMITTING RESPONSES FROM EXPERT COMMITTEE REVIEW?

7 working days after receipt of comments

HOW DO I ARRANGE A MEETING WITH THE CLINICAL TRIALS COMMITTEE / SAHPRA?

The request must be initiated through the office of the CEO. Please refer to the guideline Link Procedure for Consultation Meetings with Clinical Trial Applicants.

CLINICAL TRIAL INVESTIGATORS / CLINICAL TRIAL FACILITIES

WHAT ARE THE REQUIREMENTS FOR BEING A PRINCIPAL INVESTIGATOR OR CO-INVESTIGATOR?

The requirements for participating as an investigator are obtainable from link in the document titled Clinical Trial Investigators

WHAT ARE THE BASIC REQUIREMENTS FOR A CLINICAL TRIAL SITES TO DEAL WITH EMERGENCIES?

The requirements for emergency procedures at clinical trial site are obtainable from link the document titled Emergency Procedures for Clinical trial sites.

SUBMISSION OF AN AMENDMENT APPLICATION (POST APPROVED PROCESSES)

HOW DO I SUBMIT A PROTOCOL AMENDMENT OR AN APPLICATION SITE/INVESTIGATORS?

Refer to Link  under Electronic submission of clinical trial documents

WHAT IS THE EXPECTED TO RECEIVE THE RESPONSE AFTER THE SUBMISSION OF APPLICATION FOR ADDITIONAL FOR INVESTIGATORS, SITE AND PROTOCOL AMENDMENT?

6 weeks following receipt of the application.

HOW DO I I ENQUIRE REGARDING THE APPLICATION FOR ADDITIONAL SITE/INVESTIGATORS AND PROTOCOL AMENDMENT?

The applicant should email to:

Protocol amendments:ctcamendments@sahpra.org.za

Additional sites/Investigators:ctcinvestigators@sahpra.org.za

Contact us

E-mail address for New clinical trials application alert, Responses to new Clinical Trial applications and related queries:

ctcresponses@sahpra.org.za

E-mail address for Protocol amendments, responses to amendments and related queries: ctcamendments@sahpra.org.za

E-mail address for Additional Investigators & Sites, responses to additional and related queries: ctcinvestigators@sahpra.org.za

E-mail address for Bioequivalence studies, BE amendments, responses to BE studies and related queries: 

ctcbeprotocols@sahpra.org.za

E-mail address for Notifications and related queries:

ctcnotifications@sahpra.org.za

E-mail address for Individual Patient Serious Adverse Events and related queries:

ctcsaes@sahpra.org.za

E-mail address for SAHPRA Guidelines, forms and  related queries:

 CTCGuidelines@sahpra.org.za