Question NW96 to the Minister of Health
23 February 2024 - NW96
Hicklin, Ms MB to ask the Minister of Health
With reference to the 2022-23 financial year budget report of the South African Health Products Regulatory Authority, whose objective is to, amongst others, monitor and evaluate, regulate, investigate, inspect, register and control of medicines, clinical trials and devices relating to public health matters, only 22% of new Good Manufacturing Practices and Good Warehouse Practices related to licenses were finalised in 125 days, what (a) are the financial implications for those whose licenses were submitted and not granted, (b) were the reasons the licences were not granted and (c) licenses were not granted?
Reply:
According to the SAHPRA:
a) SAHPRA has the mandate of regulating the efficacy safety and quality of medicines and thus the information supplied in a license application does not include information about the financial implications of not having a license ;
b) There are various reasons licenses are not granted but in essence applicants must comply with the criteria for Good Manufacturing Practice (GMP) and Good Warehousing Practice (GWP). This is done in accordance with the General Regulations to the Medicines Act, Regulation 23(3) and Regulation 23(4). Noncompliance with the criteria for licensing will result in a license not being issued. In some cases applicants decline an inspection when they are contacted for assessment of their license application.
However, there were delays in finalisation of inspections due to capacity constraints in the Inspectorate unit.
c) In the 2022/2023 financial year, SAHPRA approved all new license applications that were evaluated however there are delays in the inspection of applicants due to limited inspection capacity.
END.