Regulatory Environment
At CanTx, we are committed to ensuring the highest standards of safety, quality, and compliance in the rapidly evolving plant therapy industry.
To achieve this, we strictly adhere to the regulatory environment in Australia, which is governed by a range of legislation, guidelines, and regulatory bodies that oversee the cultivation, production, supply, and prescription of plant therapy products.
Some of the key aspects of the regulatory environment in Australia include:
Therapeutic Goods Administration (TGA):
As the primary regulatory body responsible for overseeing the safety, quality, and efficacy of medicinal products in Australia, the TGA plays a crucial role in the plant therapy industry. CanTx works closely with the TGA to ensure that our products and services meet their stringent requirements, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways, which allow eligible patients to access plant therapy under the guidance of a qualified healthcare professional.
Office of Drug Control (ODC):
The ODC is responsible for regulating the cultivation, production, and manufacturing of plant therapy in Australia. CanTx complies with the ODC’s licensing and permit requirements, ensuring that our cultivation and production processes are conducted in accordance with the Narcotic Drugs Act 1967 and the associated regulations.
State and Territory Legislation:
In addition to federal regulations, plant therapy is also subject to various state and territory laws and guidelines. CanTx is committed to complying with all relevant state and territory legislation, ensuring that our products and services are accessible to patients across Australia in accordance with local requirements.
Good Manufacturing Practice (GMP):
To guarantee the quality and safety of our plant therapy products, CanTx adheres to the principles of Good Manufacturing Practice (GMP), as outlined by the TGA. This includes stringent quality control measures, standard operating procedures, and validation processes to ensure that our products consistently meet the highest standards of safety and efficacy.
Clinical Research and Ethics:
CanTx is dedicated to advancing the field of plant therapy through research and innovation. We actively participate in clinical research and adhere to the National Statement on Ethical Conduct in Human Research, ensuring that our research practices are conducted ethically, responsibly, and with the utmost respect for the rights and welfare of research participants.
By strictly adhering to the regulatory environment in Australia, CanTx demonstrates our unwavering commitment to providing safe, high-quality, and compliant plant therapy products and services. We believe that our dedication to maintaining the highest standards of safety, quality, and compliance is essential in building trust and confidence with our patients, healthcare professionals, and the wider community.
