Regulator to halve approval time for local drugmakers

SA’s medicines regulator has committed to speeding up its evaluation of locally manufactured drugs and vaccines as it seeks to reduce the country’s reliance on imports and improve security of supply.

Most pharmaceutical products sold in SA are imported, placing patients at risk when there are global shortages. SA’s vulnerability was thrown into sharp relief at the height of the Covid-19 pandemic, when nations with vaccine manufacturing capacity initially hoarded shots for their own populations and forced African countries to the back of the queue.

SA continues to face intermittent shortages of imported medicines, ranging from GLP-1 agonists used for treating diabetes and obesity to painkillers such as morphine.

The SA Health Products Regulatory Authority (Sahpra) board signed off on a policy last month prioritising the registration of locally made products with shorter evaluation times and lower registration fees.

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 such as the European Medicines Agency, due to its capacity constraints, she said.

The policy sought to support the AU’s commitment to procure 60% of Africa’s pharmaceuticals and vaccines from African manufacturers by 2040, said Semete-Makokotlela.

“Registration, if not done timeously and efficiently, can be a barrier [to access],” she said.

Products submitted for registration by local manufacturers would be prioritised over those that were not made in SA, but they would be subjected to the same level of rigour, she said.

Sahpra would charge the standard registration fee for these applications, instead of the higher rate now applied to expedited products that qualify for priority review, Semete-Makokotlela said. Sahpra can place products under priority review on public health grounds.

Pharmaceuticals Made in SA (Pharmisa), an industry association for local drug manufacturers, welcomed Sahpra’s new policy.

“The SA pharmaceutical industry operates in a highly contested and competitive environment, very often against peer countries that have a more competitive suite of industrial incentives. This policy will contribute towards making the SA pharmaceutical industrial offering more competitive,” it said.

Sahpra’s commitment to speed up evaluation times would accelerate World Health Organisation 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, he said.

The association called on the government to accelerate the introduction of public procurement regulations so that the country could “aggressively address the extensive trade deficit” in the pharmaceutical sector.

SA imported R43.9bn worth of pharmaceuticals 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.