Submission to the TGA public consultation: Regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals

Cell-Innovations welcome the opportunity to contribute to the TGA’s well-considered evidencebased consultation on the regulation of autologous cell and tissue products. Given the different pathways to medical innovation, we appreciate the challenges in consulting widely and ensuring that appropriate weighting is given to the voice of all key stakeholders. It is particularly important that biotech companies and medical practitioners are invited to collaborate fully as proposed changes to regulation will have significant impacts on clinical practice; cost of patient treatments; regulatory complexity and compliance costs; availability of investment for ongoing innovation; and the financial viability of the autologous cell therapy field of regenerative medicine.