Lenalidomide is an important medicine used for the treatment of multiple myeloma – a type of bone marrow cancer that is not curable and typically requires long-term, ongoing treatment. Over the last decade, the price of this drug has fluctuated dramatically in South Africa and patients and their doctors have gone to extreme lengths to access it. Catherine Tomlinson unpacks the remarkable recent history of lenalidomide.
South Africa does not currently register medical devices. So what does it mean when the regulator announces that a new COVID-19 test or ventilator has been authorised? Catherine Tomlinson unpacks what is required to market a medical device in South Africa.
The board of the South African Health Products Regulatory Authority (SAHPRA) has held its first meeting, thus officially bringing SAHPRA into existence. This means that South Africa’s old regulatory authority, the Medicines Control Council, no longer exists.
The MCC will soon be replaced by the South African Health Products Authority (SAHPRA). Spotlight asked MCC registrar Dr Joey Gouws and MCC chairperson Professor Helen Rees about changes at South Africa’s medicines regulator.