Question NW2053 to the Minister of Health

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09 June 2022 - NW2053

Profile picture: Chirwa, Ms NN

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 –

  1. 37 products,
  2. 389 tests,
  3. 198 personal protective equipment,
  4. 0 treatment (7 currently in process) and/or
  5. 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.

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