Legislation

Backlog fee’ would speed up registration of drugs in SA, industry body says

South African drug makers may be asked to pay a "backlog fee" to help clear a pipeline of medicines waiting years for approval, according to a proposal being considered by a new industry regulator.

Delays for hundreds of medicines have kept the latest treatments off South African shelves and have hampered the fight against cancer, heart disease and other illnesses, in a country that also has more people receiving anti-retroviral (ARV) drugs than anywhere else in the world.

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Besides improving access to life-saving medication, analysts say the South African Health Products Regulatory Authority’s (Sahpra’s) proposal could help boost revenue streams for companies competing in the $3.8bn-a-year market.

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