Document background
The Clinical Supply Agreement serves as a critical document in the Australian clinical trials landscape, establishing the legal and operational framework for the supply of investigational products and related materials. This agreement type is essential when organizing clinical trials in Australia, where compliance with Therapeutic Goods Administration (TGA) requirements and Good Manufacturing Practice (GMP) standards is mandatory. The document addresses key aspects such as product specifications, quality requirements, delivery terms, and regulatory obligations while incorporating specific Australian legislative requirements. It is typically used when a pharmaceutical company, contract manufacturer, or other supplier provides clinical trial materials to research institutions or trial sponsors. The agreement ensures clear allocation of responsibilities and risks while maintaining compliance with Australian regulatory frameworks, including the Therapeutic Goods Act 1989 and relevant clinical trial guidelines.
