According to Erik Roos, the newly appointed CEO of Pharma Dynamics, the groundwork set by the Medicines Control Council (MCC) in the past few months in preparation for the much-anticipated launch of the South African Health Products Regulatory Authority (SAHPRA) is likely to usher in a new and much more effective era for the local pharmaceutical sector. Pharma Dynamics is one of SA’s leading producers of generic medicines.
He says even though SAHPRA will only officially come into existence once the Amendment Acts have commenced, he is encouraged by the active nature in which the MCC has interacted with the Industry Task Group (ITG). This is coupled with its attempts to address the pharmaceutical industry’s concerns. Proactive action such as this by the MCC is sure to create positive momentum for SAHPRA’s launch.
Registration system efficiency set to become a reality
SAHPRA is the new regulatory authority set to take over from the MCC from April next year, since the MCC in its current form has struggled to cope with the volume of applications it receives for new medicines and clinical trials. Based on industry figures, registering new products could take anything from three to five years.
However, the MCC’s proactive approach to tackle the backlog of particularly medicine registrations in recent months has seen it making inroads into the somewhat sceptical pharmaceutical industry, which has been hamstrung by the inefficiencies within the system for years.
‘During the past quarter, key MCC officials, who have been tasked with establishing the new regulatory body, have initiated a series of meetings and roundtable discussions with various industry organisations as a way to openly engage with stakeholders. This has helped to develop fresh solutions to various challenges we face as an industry. Its hands-on approach has set in motion a circle of feedback and responsiveness, which augers well for the entity’s new transformative future and activation of SAHPRA.
‘There also appears to be much better collaboration between the industry and the MCC and there is a greater willingness to work together towards a common goal,’ Roos adds.
Inspired by international business models
In the defence of the MCC, the regulatory body has been severely understaffed with part-time academics trying their best to meet the increased demands of the industry. Roos points out that years ago, the model on which the MCC was based, was considered best practice, but now it is completely out of sync with best practices worldwide.
‘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 additional funds being raised from fees charged and services rendered within its regulatory ambit. 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,’ he concludes.