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SA drug manufacturers face significant regulator fees increases

Drug manufacturers will soon face a significant increase in the fees charged by South Africa’s new medicines regulator, as it moves to end an era in which firms enjoyed rates far below those levied in other countries, reports Business Day.

"We need to re-evaluate the fees, which are too low and in some cases non-existent," says South African Health Products Regulatory Agency (Sahpra) board chair Helen Rees,

Sahpra needs to overhaul its fee structure not only to bring its rates in line with other regulators but also to ensure it generates a significant portion of its own operational budget. Unlike the Medicines Control Council (MCC), which it replaced in February, Sahpra will be only partially funded by the state.

The report says the government anticipates that allowing Sahpra to retain the revenue it generates will provide the resources to improve its in-house capacity, which is vital if it is to speed up the approval of new products.

Consultation was under way with the pharmaceutical industry to ensure the fees were fair and reflected the value provided by the regulator, said Rees. The enabling legislation for Sahpra gave it wider powers than the MCC, and it was exploring a range of possible mechanisms for tackling the massive backlog of products awaiting approval, she said. It has established a technical subcommittee, headed by Shabir Banoo, to craft a more efficient way of doing business.

There report quotes Vivian Frittelli, CEO of Generic and Biosimilar Medicines Southern Africa, as saying there are at least 3,000 dossiers for generic medicines and more than 100 dossiers for new chemical entities that have yet to be scrutinised.

Rees said the options being explored by Sahpra included measures to expedite approval times for products that have already been approved by stringent regulators recognised by the World Health Organisation, reviewing dossiers for similar products as a group, and mechanisms to deal with poor-quality submissions. Sahpra was not planning to charge fees to clear the backlog, she said.

Frittelli said the Pharmaceutical Task Group, which represents all South Africa’s pharmaceutical manufacturer associations, had submitted proposals for speeding up approval times. The report says it favoured the approach taken by Singapore, which applied an expedited process for products that had been approved by two stringent regulators, resulting in a turnaround time of 120 days.

[link url="https://www.businesslive.co.za/bd/companies/healthcare/2018-04-12-bitter-pill-for-drug-makers-as-fees-hike-nears-under-new-regulator/"]Business Day report[/link]

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