a) The South African Health Products Regulatory Authority (SAHPRA) has processed –
- 37 products,
- 389 tests,
- 198 personal protective equipment,
- 0 treatment (7 currently in process) and/or
- 12 vaccines related to COVID – 19;
b) (i) 494 processed items were approved and
(ii) 275 were rejected; and
(c) the reasons for decision made in each case are as follows:
- Incomplete documents submitted,
- Test kits not meeting performance requirements, and
- No originating approval from one of the 6 recognized jurisdictions.
END.