Implementation of the human cellular and tissue therapies (HCT) regulatory framework
23 September 2008
Implementation of the HCT framework
The Australian Government has recently agreed to proceed with the establishment and implementation of the human cellular and tissue therapies (HCT) regulatory framework. Currently the framework excludes assisted reproductive tissues and solid organs. The possible regulatory arrangements for solid organs have been referred to the new national organ donation and transplantation authority. Haematopoietic Progenitor Cells (HPCs) will be included in the HCT regulatory framework at a later date following further discussion with the sector.
The HCT regulatory framework is expected to be implemented in 2010 with a transition period for products to move into the new scheme.
Background to the Government decision
The existing therapeutic goods regulatory framework is currently not well adapted for human cell and tissue therapies. In response to this shortcoming, the Australian Health Ministers' Conference (AHMC) in 2002 endorsed the development of a regulatory framework for HCTs by the TGA.
In 2006 AHMC agreed to the proposed National HCT regulatory framework (the HCT framework) with the exclusion of solid organs and assisted reproductive tissues (ART), which are still being considered.
The HCT framework was to be implemented as part of the proposed Australia and New Zealand Therapeutic Products Authority (ANZTPA) but due to the postponement of the ANZTPA in July 2007 the implementation of a number of regulatory reforms including the HCT regulatory framework has been delayed. The Government has now agreed that a number of these regulatory reforms should proceed in an Australian only context.
Staying up-to-date on implementation of the HCT framework
Interested parties are encouraged to:
- complete the facilities registration update form <http://www.tga.gov.au/bt/hctfacilityreg.htm> and mail or fax to the TGA or
- register your interest to be included in future mailouts by emailing bloodandtissues@tga.gov.au.