ABSTRACT
â¢In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator.â¢The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.â¢It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.â¢Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions.
ABSTRACT
Cell and gene therapy products are rapidly being integrated into mainstream medicine. Developing global capability will facilitate broad access to these novel therapeutics. An initial step toward achieving this goal is to understand cell and gene therapy manufacturing capability in each region. We conducted an academic survey in 2018 to assess cell and gene therapy manufacturing capacity in Australia and New Zealand. We examined the following: the number and types of cell therapy manufacturing facilities; the number of projects, parallel processes and clinical trials; the types of products; and the manufacturing and quality staffing levels. It was found that Australia and New Zealand provide diverse facilities for cell therapy manufacturing, infrastructure and capability. Further investment and development will enable both countries to make important decisions to meet the growing need for cell and gene therapy and regenerative medicine in the region.
Subject(s)
Cell- and Tissue-Based Therapy , Genetic Therapy , Manufacturing and Industrial Facilities/supply & distribution , Australia , Cell- and Tissue-Based Therapy/methods , Cell- and Tissue-Based Therapy/standards , Cell- and Tissue-Based Therapy/statistics & numerical data , Clinical Trials as Topic/methods , Clinical Trials as Topic/statistics & numerical data , Genetic Therapy/legislation & jurisprudence , Genetic Therapy/methods , Genetic Therapy/standards , Genetic Therapy/statistics & numerical data , Government Regulation , Healthcare Financing , Humans , Manufacturing and Industrial Facilities/legislation & jurisprudence , Manufacturing and Industrial Facilities/organization & administration , Manufacturing and Industrial Facilities/statistics & numerical data , New Zealand , Regenerative Medicine/legislation & jurisprudence , Regenerative Medicine/standards , Regenerative Medicine/statistics & numerical dataABSTRACT
Emollient cream may alleviate pain and dryness and improve the appearance of heel cracks.
