FARMOVS Regulatory Services Division

Experienced regulatory submission and approval specialists 

The diversity of the South African study population has multiple benefits. However, regulatory submission and approval may become cumbersome if you are not well acquainted with the regulatory landscape. The FARMOVS Regulatory Team is experienced in this landscape, and routinely prepares clinical trial application packages for the South African Health Products Regulatory Authority (SAHPRA) and research ethics submissions. We ensure that regulatory submissions are of the highest quality to secure favourable outcomes for our clients in the shortest possible time.

Expected timelines for regulatory approval:

  1. Bioequivalence/bioavailability studies in healthy volunteers, including generic product development, takes approximately eight weeks from submission to approval. These studies are reviewed by a specialised team at SAHPRA that attends to generic studies. Applications can, therefore, be submitted at any time.
  2. All other studies are reviewed by the SAHPRA Clinical Trials Committee (CTC). Submissions are done according to the CTC submission calendar, and meetings take place every eight weeks. Approval of a successful submission is typically received within 12 to 14 weeks after submission.

Expected Timelines for research ethics approval:

1. Clinical trial applications are submitted to the Health Sciences Research Ethics Committee (HSREC) of the UFS, for research ethics review.
2. The HSREC reviews applications on a monthly basis and submissions have to be presented at least two weeks prior to a scheduled meeting date.
3. Required modifications are communicated shortly after the meeting, and conditional approval (pending SAHPRA approval) is obtained within ten working days after submission of our responses to said modifications.

Our team is well acquainted with the South African regulatory landscape.