Australia Plans New Approval Pathways To Foster Earlier Access To Novel Drugs
The Australian government has come up with a set of proposals for reforming the drug and medical device regulatory framework, which include speeding up access to innovative drugs through expedited and provisional approval mechanisms and greater use of assessments by overseas regulators. The changes will be phased in over a period of about three years and may include some recovery of costs from industry.
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New proposals by Australia’s Therapeutic Goods Administration include developing a list of unauthorized drugs that could be made available to patients faster and more easily. A decision to include a product on the list would not be appealable, the TGA says.
The Australian parliament has held its first reading of a bill that will implement a number of new measures in the pharmaceutical area, including two new expedited drug approval pathways and a risk-based approach to variations.
Australia believes that using overseas assessment reports will help the Therapeutic Goods Administration cut the time it takes to review drug applications by up to three months. Meanwhile, a work-sharing scheme could make it easier for applicants to enter multiple international markets.