English A Must In Australian Proposals On Using Overseas Assessments
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.
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Plans for new speedier routes to market are moving ahead as the Australian government announces a public consultation on the proposals for priority review and provisional approval pathways that were announced in September.
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.
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.