Question NW2053 to the Minister of Health
09 June 2022 - NW2053
Chirwa, Ms NN to ask the Minister of Health
What (a) total number of COVID-19 related (i) products, (ii) tests, (iii) personal protective equipment, (iv) treatment and/or (v) vaccines has the SA Health Products Regulatory Authority processed, (b) number of the processed items were (i) approved and/or (ii) rejected and (c) are the reasons for each decision made in each case?
Reply:
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.