Australia's TGA progresses Provisional Approval pathway for medicines

Australia’s Therapeutic Good Administration (TGA) has released draft guidance documentation for the Provisional Approval pathway for prescription medicines that is currently being developed in response to recommendations of the Medicines and Medical Devices Regulation Review.

The TGA says that implementation is planned for January 2018, subject to the passage of amendments to the Therapeutic Goods Act and Regulations, which are currently before the lower house.

Eligibility for the Provisional Approval pathway will be determined through a formal designation process. The sponsor must demonstrate the seriousness of the condition, comparison against existing registered therapeutic goods and promising evidence of a major therapeutic advance.