The SA Health Products Regulatory Authority (SAHPRA) has pledged to expedite its evaluation of locally manufactured drugs and vaccines by prioritising the registration of local products in efforts to drastically reduce reliance on imports and improve security of supply, reports Business Day.
With most pharmaceutical products sold in this country being imported, intermittent shortages are not infrequent, ranging from GLP-1 agonists used for treating diabetes and obesity to painkillers like morphine.
SAHPRA CEO Boitumelo Semete-Makokotlela said the agency aimed to halve the registration time for locally manufactured vaccines from 360 working days to 180. Its review times were longer than other stringent regulators like the European Medicines Agency, due to its capacity constraints, she added, but the new policy aimed to support the AU’s commitment to procure 60% of Africa’s pharmaceuticals and vaccines from African manufacturers by 2040.
But while products submitted for registration by local manufacturers would be prioritised over others, they would still be subjected to the same level of rigour, she said.
Pharmaceuticals Made in SA (Pharmisa) welcomed the new policy saying this would contribute towards making the local pharmaceutical industrial offering more competitive.
The commitment to escalate evaluation times would accelerate WHO pre-qualification, a vital step for vaccine and pharmaceutical manufacturers seeking to supply international agencies such as Unicef that procure for the African market, said Pharmisa chair Stavros Nicolaou.
It would also improve investor sentiment and make SA more attractive for potential technology partners.
SA imported pharmaceuticals worth R43.9bn in the year to May and exported R7.85bn in pharmaceuticals over the same period, according to the Observatory of Economic Complexity, an online platform for international trade data.
“Given our burden of disease, it has always been counterintuitive to run a trade deficit of this magnitude,” it said.
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