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South Africa tackles drug approval delays


JOHANNESBURG- South Africa will almost triple the number of workers at its drugs regulator in the next 3-5 years, a consultant said on Tuesday, as part of broader plans to slash long drawn-out registration timelines to as little as six months.

The Medicines Control Council (MCC) takes as long as 5 years to get drugs on the pharmacy shelves, eating into the profits of local drug makers and denying timely access to cheaper, more effective medicines to the nation’s sick.

“The intention is to have full-time employed staff, not scores of people with other jobs that keep them occupied,” said Dr Nicholas Crisp, a consultant leading a team tasked with overhauling the crumbling regulator.

Crisp told Reuters in an interview that the new agency – the South African Health Products Regulatory Authority (SAHPRA) – set to replace the MCC would have about 400 permanent staff compared with 150 currently.

SAHPRA, which would also increase its functions to regulate food, medical devices and in vitro diagnostics, aims to cut the registration timelines for name-brand drugs to 24 months and 12 months for generics by 2015.

The new regulator is expected to start operating by Apri1 2013. It hopes to eventually chop registration timelines to 12 months for name-brand drugs and 6 months for generics, bringing it in line with the global average of about 14 months.

“We are not trying to be the FDA, but compared with other agencies in the rest of Africa, this new entity would be a Rolls-Royce,” Crisp said.

The MCC currently gets about 800 new drug applications every year but its staff and part time workers that include university professors can only process about 200, creating a backlog that could take as long as five years to move through.


While the registration of critical drugs such as HIV/AIDS medicines have been fast-tracked in the recent past, others, according to industry, such as the generic version of best-selling cholesterol drug Lipitor take longer.

One company executive, who declined to be named, said the backlog was costing the industry as much as 3 billion rand in lost sales each year.

“Companies are starting to ask themselves questions. Is it worth their whiles in bringing these medicines to this country and costing them so much in regulation processes?,” said Val Beaumont, Executive Director at industry body Innovative Medicines South Africa.

Adcock Ingram, the nation’s second-biggest drugs maker, has more than 600 applications at the MCC with some of them having being filed almost four years ago.

“We have the highest number of drugs sitting with the MCC in the industry,” Jonathan Louw, Adcock’s chief executive officer said, adding that in the pile was the generic version of Lipitor.

Litha Healthcare has nearly 300 dossiers awaiting approval by the MCC. “The delays have become normal and part of doing business in South Africa,” chief executive Selwyn Kahanowitz said.

The MCC revamp, which also includes moving to electronic applications, could also reduce the administrative burden of evaluating drugs that have already received a thumbs-up in other countries with which South Africa is trying to reach an agreement.

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