Summary of evidence, reporting and advertising requirements for the regulatory options for autologous cells Issue Option 1 Option 2 Option 3 Option 4 Option 5 Evidence to No requirement No requirement for review No requirement for Applicant for Class 1 must Evidence of safety and support the for review the under the Act but only product to be safe or certify that the product is safe efficacy required before safety and Act. excluded if homologous use efficacious. for the purpose for which it is to inclusion in the ARTG. efficacy of and not subject to more than be used (grounds for the product minimal manipulation thus /suspension cancellation if that represent less risk. statement false or misleading). Advertising No requirements No advertising to the public, No advertising to the No advertising to the public. No advertising to the of the under the Act but advertising permitted to public. public. product subject to ACCC health practitioners and and AHPRA subject to AHPRA regulation. regulation. Reporting of No requirements No requirements under the Yes, there would be a Yes, there would be a Yes, there would be a adverse under the Act. Act. requirement for reporting requirement for reporting requirement for reporting effects of the adverse effects related to adverse effects related to the adverse effects related to product the product if the product. the product. conditional exemption under Schedule 5A was adopted.
Summary of evidence, reporting and advertising requirements for the regulatory options for autologous cells Issue Option 1 Option 2 Option 3 Option 4 Option 5 Evidence to support the safety and efficacy of the product No requirement for review the Act. No requirement for review under the Act but only excluded if homologous use and not subject to more than minimal manipulation thus represent less risk. No requirement for product to be safe or efficacious. Applicant for Class 1 must certify that the product is safe for the purpose for which it is to be used (grounds for /suspension cancellation if that statement false or misleading). Evidence of safety and efficacy required before inclusion in the ARTG. Advertising of the product No requirements under the Act but subject to ACCC and AHPRA regulation. No advertising to the public, advertising permitted to health practitioners and subject to AHPRA regulation. No advertising to the public. No advertising to the public. No advertising to the public. Reporting of adverse effects of the product No requirements under the Act. No requirements under the Act. Yes, there would be a requirement for reporting adverse effects related to the product if the conditional exemption under Schedule 5A was adopted. Yes, there would be a requirement for reporting adverse effects related to the product. Yes, there would be a requirement for reporting adverse effects related to the product.
consult-autologous-stem-cell-150106.docx