Drug watchdog launch delayed
• Enabling regulations for new medicines registrar not yet published
The Department of Health will miss its April 1 deadline for establishing the South African Health Products Regulatory Agency (SAHPRA) by several months, disappointing drug companies hoping for a swift end to the delays they face in registering medicines.
SAHPRA will replace the overwhelmed Medicines Control Council (MCC), which has a backlog of up to five years for registering new chemical entities, and up to almost three years for registering generic drugs, according to industry sources.
The new watchdog will have a much wider mandate than the MCC, which regulates medicines and clinical trials, as it will also oversee medical devices and complementary medicines.
It will be a public entity that can retain the fees it generates from applications to register products and clinical trials and will be able to remunerate employees above public service rates, enhancing its ability to attract and retain staff.
The implementation of SAHPRA has been held up by a delay in publishing its enabling regulations, says MCC registrar Joey Gouws. Draft regulations to the Medicines and Related Substances Amendment Act were gazetted only on January 27, with a three-month window for comment that closes at the end of April. The department would need at least two months to consider the input from stakeholders and publish final regulations, she said.
The department had finalised the draft regulations in December but decided against publishing them over the Christmas period when many industry players shut shop.
“Industry would have complained it was not in good spirit if we’d published then,” she said.
There were no substantive changes to the latest iteration of the draft regulations, which had previously been published for comment, Gouws said. The department would publish SAHPRA’s fee structure within the next few weeks, she said.
Aspen’s head of strategic trade, Stavros Nicolaou, said one of the most important issues confronting the regulator was building its capacity to assess registration applications and postregistration amendments, required when pharmaceutical manufacturers change suppliers. Aspen’s generic medicines that were not given “fast-track” status took up to 34 months to register with the MCC, he said.
Innovative Pharmaceutical Association of SA (Ipasa) CEO Konji Sebati said the longer the delay in launching SAHPRA, the longer patients were being denied access to essential medicines. New drugs took up to five years to register with the MCC, she said.
Ipasa was relieved over the release of the “long-awaited” regulations. “We regard this as a good sign towards some finality on this long-overdue migration from the archaic MCC system.”
The association hoped SAHPRA would be “streamlined and well-resourced to handle the increasingly sophisticated scientific advances and complexities of innovative products efficiently and effectively”, said the Ipasa CEO.