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South African Health Products Regulatory Authority (SAHPRA) commended for new processes

Thanks to the efforts of the South African Health Products Regulatory Authority (SAHPRA) with their Backlog clearance project which launched in August 2019, considerable progress has been made in terms of the number of applications to register new medication.

The Backlog clearance project was launched because there were about 16 000 applications in need of processing, and SAHPRA receives 4,700 new applications every year.

Cipla Medpro South Africa (Pty) Limited ("Cipla Medpro"), a wholly owned subsidiary of Cipla Limited, India ("Cipla"), is committed to producing quality medication that is safe for the public. Therefore, we have a robust engagement process with SAHPRA to work in close collaboration to ensure we can introduce novel combinations and much-needed new generic medication in the SA market.

CEO of Cipla South Africa, Paul Miller, said: "SAHPRA has performed exceptionally well during the Backlog clearance project, which was committed to the unprecedented acceleration of approvals. The transparency and engagement around the new process and predictability of the submission windows for new product approvals is commendable and results in people getting access to life-saving medications, such as HIV paediatric formulations."

Miller met with SAHPRA's new CEO, Dr Boitumelo Semete-Makokotela, this week around securing the necessary approvals for critical medication. Cipla worked closely with SAHPRA for the registration of its recently launched paediatric antiretroviral, a 2-in-1 combination of lopinavir/ritonavir oral pellets (LPV/r), called Lopimune. This oral medication is a pellet formulation, which is more palatable especially for children. This medication is critical in light of the fact that, according to UNAIDS, it's estimated that 1.7 million population under the age of 15 are living with HIV and more than 300 children still die of HIV every day.

Beyond the advantages of administration and the ease of storage (unlike the oral solution, it does not require refrigeration) of the new medication, results of studies conducted in Kenya, Uganda and Tanzania have shown very high levels of adherence and clinical improvements, as well as lower HIV viral loads, showing that improved formulations can lead to better treatment outcomes. These LIVING study findings have shown that 83% of children on the pellets are virally suppressed after 48 weeks, compared to 55% at the start of the study.

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