Legislation drafted for a new medicines regulatory body

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Draft legislation that will pave the way for a new regulatory body for medicines has been tabled in Parliament, [s]Business Day[/s] reports. It’s a development that the pharmaceutical industry hopes will improve the efficiency of the ‘slow and under-resourced’ [b]Medicines Control Council[/b], which is responsible for ensuring the medicines on the market are safe, effective and of high quality. The drug industry has complained that the council’s long approval times, which can stretch to more than three or four years.

The [b]Department of Health[/b] intends to replace the council with an authority with far wider scope, the [b]South African Health Products Regulatory Agency (Sahpra)[/b], which will scrutinise sectors of the market that have until now been unregulated, including medical devices and diagnostics. It will also be responsible for foodstuffs, cosmetics, and complementary medicines. The report says this is the government’s second attempt at enabling legislation for Sahpra, after it failed to enact amendments to the Medicines and Related Substances Act in 2008 due to technical problems.
Full Business Day report


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