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Gene Therapy Legislation in China

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.

In 2006, Hongzhang Yin published a paper covering the regulations and procedures for new drug evaluation and approval in China. Dr. Peng of Shenzhen SiBiono GeneTech Co. Ltd. published in May 2008 a paper (The application of gene therapy in China) providing an overview of the regulatory guidance for gene therapy research, product development and commercialization in China. Gendicine is highlighted as an example of the innovation occurring in the field in China.

More information about gene therapy developments in China can be found in the section "Gene Therapy in China"