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Pharma sector welcomes launch of new medicines regulator

Medicines and Related Substances Amendment Act

SAHPRA to usher in a new and much more effective era for the local pharmaceutical sector

Government has signed the Medicines and Related Substances Amendment Act (2008), marking the official existence of the much-anticipated South African Health Products Regulatory Authority (SAHPRA) as of today. The body is now in preparation to officially take over operations from the Medicines Control Council (MCC).

According to Erik Roos, CEO of Pharma Dynamics – a leading generics medicines company – SAHPRA could usher in a new and much more effective era for the local pharmaceutical sector as the MCC has struggled to cope with the volume of applications for new medicines and clinical trials.

“SAHPRA’s new structure will follow a similar model to the US Food and Drug Administration (FDA) in that it will be more independent than the MCC. Another benefit is that it will only be partly funded by government with approximately 70% of funds coming from industry bodies. This will not only enhance the entity’s ability to attract and retain the necessary skills and resources it requires to function optimally, but is critical to its success.”

Based on industry figures, registering new products with the MCC took on average three to five years and can exceed seven years. The pharmaceutical sector is hopeful that the new body will streamline processes to effectively deal with the backlog of registrations and to fast-track the approval of essential medicines, which has long been overdue.

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