Currently, the government is in the process of structuring the South African Health Products Regulatory Authority (SAHPRA) which will replace the Medicines Control Council (MCC). SAHPRA, the new regulatory body, will be responsible for speeding up the drug registration process. SAHPRA will have more power and a greater range of responsibilities such as the approval and licensing of pharmaceuticals and medical devices, as well as carrying out evaluations for safety and efficiency.

This is hailed as a move in the right direction by many, most of whom previously condemned the MCC’s lengthy registration process for making it difficult to introduce cheaper generic drugs. This was highlighted as a major obstacle to Fixed Dose Combinations (FDCs) for HIV/AIDS treatment.

Despite all these challenges, the South African healthcare industry is in the initial stages of development and has immense growth potential. The forecast is based on high demand for hospital services and healthcare professionals, and South Africa’s dependence on imported pharmaceuticals. This sets the stage for the private sector to build infrastructure and manufacturing facilities. Based on current market trends, industrial developments and competitive landscapes, the South African pharmaceuticals and healthcare industry has a bright future ahead.


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