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Fast track approval process for new drugs

fast drugs approval
29 September 2016

MS Australia joins with other health organisations in welcoming the recent announcement by the Federal Health Minister Sussan Ley, to fast track the approval processes for new drugs to be introduced into Australia.

Recent media reports indicate that at the moment there can be up to two years wait to access some drugs that are already available in the USA and Europe.

Under the changes announced by the Health Minister, any drug that has been listed by a comparable overseas regulator (e.g. the U.S. Food and Drug Administration and the European Medicines Agency) can be fast tracked for approval in Australia by the Therapeutic Goods Administration (TGA).

The Health Minister has made it clear the TGA will still have final approval over whether any particular drug is made available in Australia, but the TGA being able to access the information and evidence collected by overseas regulators will certainly speed the process up, which will ultimately benefit people with MS in Australia keen to access these drugs.

In welcoming this announcement, MSA CEO Deidre Mackechnie said, “There are currently around 11 drugs available in Australia for the treatment of MS, and there is at least one in the pipeline that we know of that is available in the US, but not yet listed by the TGA in Australia. This fast tracking process will be welcome news to many people in Australia with MS, anxious to discuss the latest treatments with their medical team.  It can be very frustrating when information about new treatments is so readily available on the web, yet we have to keep telling people in the MS community here to ‘wait and see’.”

Fortunately, in Australia, successive governments over the years have made all of the MS treatments approved by the TGA more affordable to people with MS by listing them on the Pharmaceutical Benefits Scheme (PBS).  Ensuring drugs are safe and effective through approval by the TGA and being made accessible and affordable through the PBS is central to improving the lives of the more than 23,000 people with MS in Australia, many of whom depend on these medications to manage their MS.