Health Minister Dr Aaron Motsoaledi has appointed the new board of the South African Health Products Regulatory Authority (SAHPRA), which sets in motion the replacement of the Medicines Control Council (MCC).
In June 2017 the Health Minister invited the public to submit nominations for people who had expertise in the fields of medicine; medical devices; IVD, vigilance; clinical trials; good manufacturing practice; public health or epidemiology; law; good governance; financial matters and accounting; information technology (IT); an human resource management.
According to CEO of Pharma Dynamics, Erik Roos, the 15-member board appointment of SAHPRA takes the country one step closer to the efficient processing of medicine registrations, which is good news for the pharmaceutical industry and consumers alike.
“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. Registering new products with the MCC has taken an average three to five years and in some cases has exceeded seven years,” said Roos.
“The new regulator aims to streamline processes to effectively deal with the backlog of registrations and to fast-track the approval of essential medicines. The hope is that the future registration process will be completed within 18 months, which is a major improvement,” continued Roos.
Concerns have been raised that the faster approval process might impact on the quality of medication, but SAHPRA reassures that safety and efficacy of medicine won’t be sacrificed.
Following the appointment of a CEO, the new body will officially take over from the MCC.