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The TGA sought comments from interested parties on Regulation of autologous stem cell therapies, regarding whether the regulation applied to some autologous cells is appropriate, in a consultation that closed on 3 March 2015.
A total of 80 submissions were received. Of the submissions 14 from professional bodies, 12 from researchers, institutions or hospitals, 4 from industry groups, 4 from consumer groups, 20 from manufacturers, suppliers or health practitioners providing autologous stem cell therapies (businesses), 21 from patients and 5 from government bodies or other stakeholders. All submissions that were not marked as confidential are now available below in PDF format.
Consultation feedback
The TGA is currently considering all submissions that were received as part of this consultation. The TGA thanks those who took the time to make a submission and to make comments and suggestions.
The TGA is not able to approximate a timeframe for publication of the outcome of the consultation at this time.
Further information will be provided as it becomes available.
More information
Any questions relating to submissions should be directed to Dr Tony Manderson, Principal Adviser, Biological Science Section, Office of Scientific Evaluation by email to bloodandtissues@tga.gov.au or by telephone to 1800 678 799.
Submissions
A
- Consultation submission: Agency for Clinical Innovation - BMT Network Council (pdf,81kb)
- Consultation submission: Allan William Anderson (pdf,40kb)
- Consultation submission: Anonymous 1 (pdf,19kb)
- Consultation submission: Anonymous 2 (pdf,42kb)
- Consultation submission: Anonymous 3 (pdf,93kb)
- Consultation submission: Anonymous 4 (pdf,80kb)
- Consultation submission: Anonymous 5 (pdf,48kb)
- Consultation submission: Anonymous 6 (pdf,187kb)
- Consultation submission: Anonymous 7 (pdf,117kb)
- Consultation submission: Anonymous 8 (pdf,117kb)
- Consultation submission: Anonymous 9 (pdf,46kb)
- Consultation submission: Anonymous 10 (pdf,41kb)
- Consultation submission: Australasian Society for Stem Cell Research (ASSCR) (pdf,224kb)
- Consultation submission: Australian Academy of Science (AAS) (pdf,847kb)
- Consultation submission: Australian & New Zealand Association of Neurologists (ANZAN) (pdf,110kb)
- Consultation submission: Australian and New Zealand Society of Blood Transfusion (ANZSBT) - Simon Benson, President and Marija Borosak, Chair, Clinical Practice Improvement Committee (pdf,126kb)
- Consultation submission: Australian Cell Therapy Society (ACTS) - Prof Richard Boyd, Dr Dan Bates and Ms Sarah Walke (pdf,204kb)
- Consultation submission: Australian Knee Society (AKS) - Dr David Wood (pdf,215kb)
- Consultation submission: Australian Rheumatology Association (ARA) - Prof Julian McNeil, Chair, Therapeutics Committee (pdf,62kb)
- Consultation submission: Australian Society of Ophthalmologists (ASO) - Dr Michael Steiner, ASO President (pdf,241kb)
- Consultation submission: Australian Society of Plastic Surgery (ASPS) - Gaye Phillips, Chief Executive (pdf,63kb)
B
C
- Consultation submission: Cell-Innovations Pty Ltd - Wayne Thomas BSc PhD, CEO
- Consultation submission: Cell Therapies Pty Ltd (CTPL) - Dr Timothy Oldham (pdf,1.78Mb)
D
E
- Consultation submission: Endocrine Society of Australia (ESA) - Associate Professor Warrick Inder (pdf,189kb)
- Consultation submission: Enhance Yourself - Patricia Matheson, RN (pdf,119kb)
- Consultation submission: ERA Consulting (Australia) Pty Ltd (pdf,1.56Mb)
G
I
- Consultation submission: Ian Layton (pdf,38kb)
- Consultation submission: Illana Halliday (pdf,107kb)
- Consultation submission: International Society for Cell Therapy (ISCT) Australia & New Zealand - Dr Dominic Wall, Chair (pdf,118kb)
K
M
- Consultation submission: Macquarie Stem Cells - Dr Ralph T Bright (pdf,308kb)
- Consultation submission: Masterderm Clinic & Stem Cell Centre - Dr Soraya Felix, Clinical Doctor and Stem Cell Researcher
- Consultation submission: Medical Council of New South Wales - Dr Stuart Dorney, Medical Director (pdf,252kb)
- Consultation submission: Melbourne Stem Cell Centre (pdf,427kb)
- Consultation submission: Melbourne Stem Cell Centre - Dr Juian Freitag, Clinician (pdf,148kb)
- Consultation submission: Melbourne Stem Cell Centre, MP Sports Physicians - Dr Leesa Huguenin (pdf,76kb)
- Consultation submission: Metro Pain Group - Dr David Vivian (pdf,185kb)
- Consultation submission: Metro Pain Group - Dr Paul Verrills, Co-Medical Director (pdf,109kb)
- Consultation submission: Michael Sarrou (pdf,36kb)
- Consultation submission: Miltenyi Biotec Australia Pty Ltd - Paula Stoddart, National Clinical Applications Specialist (pdf,118kb)
- Consultation submission: Monash University - Chih Wei Teng, PhD Candidate (pdf,76kb)
- Consultation submission: Monash University - Dr Peter ONeill
- Consultation submission: Monash University - Professor Richard Boyd (pdf,85kb)
- Consultation submission: MS Australia - Lee Davelaar, National Communications Manager (pdf,206kb)
- Consultation submission: MS Research Australia - Dr Lisa Melton, Research Development Manager(pdf,1.25Mb)
N
- Consultation submission: National Health and Medical Research Council (NHMRC) - Professor Warwick Anderson (pdf,279kb)
- Consultation submission: National Stem Cell Foundation of Australia (NSCFA) - Graham Macdonald MD FRACP FRCP, Caroline Gargett PhD, Christopher Juttner MB BS B Med Sci FRACP, Richard Smallwood MD FRACP FRCP, Karin Tiedemann MB BS FRACP (pdf,61kb)
- Consultation submission: National University of Singapore, Centre for Biomedical Ethics, Yong Loo Lim School of Medicine - Professor Alastair Campbell, Director and Assistant Professor Tamra Lysaght (pdf,175kb)
- Consultation submission: Nepean specialist Sports Medicine and Regenexx Australia - Dr Kevin A Boundy (pdf,302kb)
- Consultation submission: Novartis Pharmaceuticals Australia Pty Ltd - Dr George Lillis, Head of Regulatory Affairs (pdf,189kb)
- Consultation submission: NSW Stem Cell Network - Professor Bernie Tuch, Director (pdf,400kb)
O
- Consultation submission: Ocular Stem Cells Australia Group - Clinical Professor Stephanie Watson
R
- Consultation submission: Regeneus Ltd - John Martin, CEO (pdf,596kb)
- Consultation submission: Royal Australasian College of Physicians (RACP) (pdf,333kb)
- Consultation submission: Royal Australian and New Zealand College of Ophthalmologists (RANZCO) (pdf,147kb)
- Consultation submission: Royal Children's Hospital - Dr Francoise Mechinaud, Director of the Children's Cancer Centre
- Consultation submission: Royal Children's Hospital, Murdoch Children's Research Institute (pdf,1.16Mb)
- Consultation submission: Royal College of Pathologists of Australia (RCPA) (pdf,315kb)
S
- Consultation submission: Sandra Sharman (pdf,276kb)
- Consultation submission: Society for Reproductive Biology (SRB) - Dr Catherine Itman (pdf,291kb)
- Consultation submission: Stem Cells Australia - Professor Martin Pera, Program Leader and Professor of Stem Cell Science and Associate Professor Megan Munsie, Head - Education, Ethics, Law and Community Awareness Unit (pdf,236kb)
- Consultation submission: Steven Pate (pdf,21kb)
- Consultation submission: Sydney Sportsmed Specialists (SSS) (pdf,625kb)