MCC team gets drugs moving
Task force cuts registration backlog Medicines approved 10 years later
November 17, 2009
By SLINDILE KHANYILE
Some medicines that have waited as long as 10 years to be registered have finally been approved.
More than 200 medicines have been registered by the Medicines Control Council (MCC) with the help of the medicines technical task team, set up to help with the backlog.
But there is still a long way to go before the backlog can be completely eradicated.
The task team, which is headed by Nicholas Crisp, has completed the audit of the backlog and found there were more than 4 000 medicines whose registrations had been delayed for various reasons.
Some of the medicines were lodged before 2000, but the bulk of them were applied for between 2001 and 2007. Crisp said some of the medicines had been evaluated, but a few outstanding requirements such as mandatory documents had stalled the process.
"There is progress, but it is going to take a long time to sort out," said Crisp. "At the rate that we are going, I would say at least two years. The MCC was doing an average of 70 medicines a meeting, but we are now doing three times that figure per meeting.
"The MCC is still doing all the work. All we have done is help them to streamline their work because the problem has been that they have been hugely under-resourced, so we have brought in a lot of clerks to take care of the paperwork."
South Africa has been criticised for taking too long to register medicines and to approve clinical trials. This made it less competitive as firms got frustrated by the length of time it took to get drugs to the market.
Two months ago, the generics industry indicated it might have potentially missed out on an opportunity to tap into pharmaceuticals worth more than R1 billion because of the delayed registrations.
This estimate was based on the fact that about R1.2bn worth of patents at originator price level had come off patent.
Companies must register drugs with the MCC when they win licences to produce the drugs before they can sell them.
Plans in the pipeline include establishing a new body that will handle the registrations, to be known as the SA Health Products Regulatory Authority. This organisation will aim to register new medicines within a year and generics within six months.
Crisp said the task team had designed the details of the new structure and hoped to table a proposal to the health minister on Friday.
The authority will have 300 employees and some of the functions that are currently done on a part-time basis will be done full-time. The authority is part of the proposals from the Medicines and Regulated Substances Amendment Bill, which was published last year.
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