The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

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

June 16, 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.

Other examples include: changes to non-sterile containers or closure systems; revisions for certain non-sterile APIs; adjustments of in-process manufacturing control tests; and changes in the location of a manufacturer, or addition of a new manufacturer, approved for quality control testing.

The FDA in its GMPs for the 21st Century report states that “The frequency and/or scope of inspections will be reduced for firms that FDA determines have acquired sufficient process understanding and have succeeded in implementing effective quality systems approaches.” Drugmaker’s Guide to ASTM E2500 shows drugmakers how using the ASTM E2500 manufacturing standard can produce the evidence the FDA needs to award that reduced scrutiny.

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