Compassionate use medicine: the new SAHPRA workflow, in three minutes
Section 21 has been renamed to Compassionate Use Medicine. Here's what changed in the eRIMS pathway — and what stayed the same.
South African regulatory folks will already know this, but for everyone else: what used to be called Section 21 applications is now Compassionate Use Medicine applications. Same statutory basis (the Medicines and Related Substances Act), new naming.
The rename is more than cosmetic. Here's what shifted inside the SAHPRA eRIMS portal.
The pathway categories
Under Compassionate Use Medicine, the four sub-pathways are unchanged in scope but relabelled in the UI:
| Old | New |
|---|---|
| S21 State Procurement (PHE) | Compassionate — State Procurement (PHE) |
| S21 Post-Trial Access | Compassionate — Post-Trial Access |
| S21 CAMS | Compassionate — CAMS |
| S21 Medical Devices | Compassionate — Medical Devices |
If you have draft applications under the old category, the portal migrates them silently — no reformatting, no re-upload. The underlying record ID stays constant, so any references sponsors have to a specific application still resolve.
What actually changed
Three things.
Wording on outcome letters. Every automatic response document has been re-templated to use "Compassionate Use Medicine" throughout.
One new field. Applications for post-trial access now require a short justification note tying the request to a specific closed or ongoing trial (CTF1 number + patient count). This was previously optional.
Sign-off routing is unchanged. The internal review committee structure is the same. Same reviewers, same score thresholds, same approval sequence.
What we're doing
The renames are already live in the portal. Documentation is being updated across the applicant guides, and we're sending a courtesy email to all active compassionate-use applicants explaining the change. Nothing you need to do — the migration is complete on our side.
If you spot a stray "Section 21" reference anywhere in the portal, send it to us and we'll fix it in the next release.
New posts, in your inbox
A short email every two to three weeks. Product notes, regulatory context, field observations. Unsubscribe any time.