Tyron Grant, Dirk Hanekom, Chyreene Truluck and Patrick O’Brien have co-authored the South Africa chapter in the 10th edition of The Life Sciences Law Review: South Africa. The chapter covers legal requirements of interest to pharmaceutical, biotechnology and medical device manufacturers and delves into regulatory regime for the approval of medicines, medical devices and in vitro diagnostic medical devices in South Africa.
The South African Pharmaceutical sector is primarily regulated by The Medicines and Related Substances Act 101 of 1965 (Medicines Act).
A number of regulations to the Medicines Act have been published. In addition, a number of Notices have been published in the Government Gazette relating to certain administrative aspects under the Medicines Act.
The Medicines Act is administered by the South African Health Products Regulatory Authority (SAHPRA), which took over administration of the Medicines Act from its predecessor, the Medicines Control Council (MCC). The MCC, and later the SAHPRA, have issued a number of guidelines relating to all aspects of approval of medicines.
The world has been gripped by the covid-19 pandemic and the response to the pandemic by the SAHPRA has included several initiatives aimed at minimising the potential negative impact of the pandemic on the availability of medicines and medical devices in South Africa, including ensuring the uninterrupted supply of medicines, medical devices, in vitro diagnostics and medical equipment, particularly those used to manage covid-19 as well as other priority diseases; and collaborating with regulators around the world to ensure availability of safe, efficacious and quality medicines and medical devices required to manage patients affected by covid-19.
To read the Life Sciences Law Review: South Africa chapter click here