The Australia New Zealand Therapeutic Products Authority (ANZTPA) said it wants to balance the need to protect the public health with the intention to foster clinical research and provide timely access to therapeutic products and is therefore proposing two separate routes for the clinical trial approval process under a new scheme based on the same risk-managed principles it currently uses to monitor approved medicines.

Studies that are deemed (usually by an ethics committee) to be 'high risk' would be required to follow the Clinical Trial Assessment (CTA) route while all other studies would follow the less stringent Clinical Trial Certification (CTC) pathway.

In addition, it is proposed that clinical trials involving the first administration in humans of a "new" substance(s); a novel active implantable (or organ support) medical device ; a hybrid medicine/biological device; gene therapy products; Class 4 human cells or tissues; or xenotransplantation, should follow the CTA route.

Sponsors directed onto the CTA path would be required to submit a package detailing preclinical and toxicological data; summary quality control data for the manufacturing to date; data relating to any relevant clinical experience; the proposed guidelines for the use of the product in any subsequent clinical trials; a justification for the use of the product in the trial; and a description of how the safety of the participant is protected within the trial protocol.

The ANZTPA may request additional data during the evaluation process and sponsors will receive a decision within 45 working days.

All subsequent trials for the same compound and are consistent with the approved usage guidelines may proceed via the CTC route.

Under the CTC route, the proposed trial would first have to receive ethics approval and then the sponsor would need to provide evidence by way of selfcertification that the trial protocol and proposal has undergone a scientific and ethical review, along with confirmation form and details of the committee; along with evidence that the product is manufactured in a GMP licensed facility or equivalent.

In addition, clinical trials involving the first use of a therapeutic product in a new patient group, or a new indication, or via a substantially different route of administration; as well as gene therapy, xenotransplantation or use of class IV human cells or tissues that have previously been allowed to follow the CTC route of approval will also be required to submit basic trial documentation, such as the

Investigator's brochure, protocol and patient information and consent documents.

The ANZTPA is now taking comments on its scheme, titled 'Proposed clinical trial regulatory arrangements under the Australia New Zealand Therapeutic Products Authority' and the deadline closes on 18 April 2007.