International

The Biologics and Genetic Therapies Directorate is actively involved in a number of global initiatives to support and enhance our regulatory framework. We strive to stay current with other leading regulatory authorities and with the latest developments within the scientific community, so that we can influence the development of high safety and quality standards for biologics, radiopharmaceuticals, and genetic therapies, both domestically and internationally.

Cooperative Agreements and Activities

TGA / BGTD Parallel Review Project

International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use

International Strategy and Inventory