Australia Gets Tough on Orphan Drug Makers: Delay Filing and Designation Will Lapse
Australia is updating its nearly two decades-old orphan drugs program. Sponsors who fail to file for approval within a set period will see their designation disappear.
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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.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
New medicines under evaluation at the European Medicines Agency.