Although SA’s medicines regulator has finally cleared its backlog of applications for registering new products, more than a year after its initial target of August 2021, critics say it still takes too long to register new and potentially lifesaving medicines in the country.
The South African Health Products Regulatory Authority (SAHPRA) inherited a backlog of more than 16 000 registration applications when it was formed from the Medicines Control Council in 2018. The list included applications for new chemical entities, generic copies of older drugs no longer protected by patents, and requests to make changes to formulations or suppliers of active pharmaceutical ingredients.
Half of the applications were more than five-years-old, and the oldest dated back to 1992, reports Business Day.
Backed by funding from Treasury and external donors, SAHPRA worked with the industry to reduce the backlog and redesign its processes, while drug companies withdrew thousands of older applications because the products were no longer commercially viable or because the market was saturated with similar products.
SAHPRA also initiated systems so it could use the decisions made by stringent regulators like the US Food and Drug Administration (FDA) to escalate scrutiny of the dossiers it received from pharmaceutical companies.
“While there has been an improvement, SAHPRA is under-capacitated and underfunded, and not where it needs to be,” said Stavros Nicolaou, chairperson of the Pharmaceutical Task Group (PTG), which represents SA’s key associations for drug manufacturers.
PTG’s members represent 80% of the SA market, and include the Innovative Pharmaceutical Association SA, Generic and Biosimilar Medicines of Southern Africa, Pharmaceuticals Made in SA, and the Self-Care Association of SA.
Before SAHPRA began tackling the backlog, it took between five and seven years to register new chemical entities, and three to four years to register generic medicines, said Nicolaou. The backlog project reduced the turnaround time to around 18 months, but SAHPRA is still slower than many other stringent regulators, he said.
Cancer Alliance treatment advocate Salomé Meyer said SAHPRA had prioritised registration applications for cancer medicines, but it still took far too long to approve new drugs. “It is unacceptable that it takes SAHPRA more than two years to approve a molecule that is in fact lifesaving,” she said.
Business Day article – Access to new life-saving drugs speeds up (Open access)
See more from MedicalBrief archives:
SA drug makers may have to pay backlog fee to clear pipeline
Hawks and SAHPRA raid for ‘COVID cure’ blocked by SANDF
SAHPRA yet to receive registration applications for novel oral treatments for COVID-19