Australia planning new approval pathways

Australia's Therapeutic Goods Administration said it plans to implement new approval pathways and allow companies to submit unredacted evaluation reports from comparable overseas regulators in an effort to improve and speed access to therapeutics.

Among the new pathways is an expedited approval pathway that allows for accelerated assessment of new medicines. TGA intends for its eligibility criteria for the pathway to be consistent with comparable regulators' criteria, and expects to weigh factors including the seriousness of the disease, alternative effective interventions, and the "extent of innovation" the medicine offers. ...