FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Plans to Allow Automatic, Instant Approvals of Lowest-Risk Product Variations

June 15, 2017

The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes immediately.

The industry requests will be characterized as notifications, but will still legally require an application to be approved by the TGA. The process is currently pending, awaiting legislative amendments by the Australian Parliament.

Sponsors must submit notification requests using an electronic form, pay a fee and provide assurances that the changes will not affect the quality, safety and efficacy of the medicine.

Changes in manufacturing methods for solid and inhaled non-sterile doses that are not modified release, as well as changes in batch sizes, would be considered appropriate variations for prescription drugs.

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