The competent authority for clinical gene therapy trials in Australia is the Department of Health and Ageing. Information about legislation of clinical trials with GMOs is described in the Gene Technology Regulations. The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing and is responsible for administering the provisions of the legislation concerning medicines, including clinical gene therapy trials. The Office of the Gene Technology Regulator (OGTR) has been established within the Australian Government Department of Health and Ageing to provide administrative support to the Gene Technology Regulator in the performance of her functions under the Gene Technology Act 2000 (see also Handbook on the Regulation of Gene Technology in Australia).

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In May 1993, the Chinese Ministry of Public Health released “An Outline of Quality Controls for Clinical Studies of Human Somatic and Gene Therapy.” It was further revised in June 1999 and reissued as “Guiding Principles for Human Gene Therapy Clinical Trials”. In realization of the rapid development in gene therapy, the State Food and Drug Administration of China (SFDA) published in March 2003, a document named  “Guidance for Human Gene Therapy Research and Its Products”. This guidance document outlined requirements for application of gene therapy clinical study, study protocol format, and requirements for construction of a recombinant DNA and gene delivery system. The document also outlined requirements for the establishment and testing of cell bank and engineered strains, manufacturing process, quality controls, and product efficacy and safety tests.

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