Cell and tissue-based medicines represent a growing segment of the biopharmaceutical industry in Australia and worldwide. New technological advancements bring hope of treatment to sufferers of a variety of complex diseases. However, cell and tissue therapies pose challenges and raise controversial issues from scientific, ethical, social and legal perspectives. The TGA Biologicals Regulatory Framework legislation commenced in 2011 with the intention of improving the regulation of human cell and tissue based therapies in Australia. This Biologicals Framework was designed to apply different levels of regulation to products based on the risks associated with their use. However, there are some biological materials that are being developed or used clinically that are not covered by the Biologicals framework, creating gaps and hot spots in the field. A “gap” might be nonhuman cell and tissue (xenotransplantation) products, which remain regulated as therapeutic goods but are NOT included as biologicals. A “hot spot” might be the EXCLUDED autologous cells used in treatment of a patient under the supervision of a medical practitioner, and indeed, this segment is currently under a TGA consultation with stakeholders. For clinical use and or research on cell and tissue products, challenges are presented to both local and overseas entities wishing to develop technologies and therapies. Assessing and assuring the quality and safety of a biological medicine is also challenging. TGA’s risk-based approach for compliance with GMP conditions across the classes of products can be compared with manufacturing requirements in other major jurisdictions. This session will cover advancements and topical issues in the cell and tissue therapy space in Australia, Asia, Europe, and the US, to provide attendees with an overview relevant to future development for funding, partnering or extensions to overseas clinical work. Presentations will include a review of EU regulations and guidelines on cell and tissue products, and cases of device combinations with biologicals will focus on the regulation of devices or device-like components required by many cell therapies.
Chairperson: Dr Daina Vanags, ERA Consulting