In this article,an expansive interpretation of“Tissue Engineering”is proposed which is in congruence with classical and recent published definitions.I further simplify the definition of tissue engineering as:“Exert...In this article,an expansive interpretation of“Tissue Engineering”is proposed which is in congruence with classical and recent published definitions.I further simplify the definition of tissue engineering as:“Exerting systematic control of the body’s cells,matrices and fluids.”As a consequence,many medical therapies not commonly considered tissue engineering are placed in this category because of their effect on the body’s responses.While the progress of tissue engineering strategies is inexorable and generally positive,it has been subject to setbacks as have many important medical therapies.Medical practice is currently undergoing a transition on several fronts(academics,start-up companies,going concerns)from the era of“replacement medicine”where body parts and functions are replaced by mechanical,electrical or chemical therapies to the era of tissue engineering where health is restored by regeneration generation or limitation of the body’s tissues and functions by exploiting our expanding knowledge of the body’s biological processes to produce natural,healthy outcomes.展开更多
The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulato...The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulatory framework has been constructed in the USA and EU, in which risk-based regulatory strategy is used to determine which regulatory mode is more desirable between medical technique and medical product. Also, it is suggested that two-tier regulatory framework of medical products be constructed, with the first level built on existing and newly introduced regulatory provisions and the second technical level encompassing all the technical requirements. In China, the demarcation line between medical technique mode and medical product mode is not made clear and coherent and flexible regulatory framework has not been intentionally designed. If the recommendations concerning the desirability of regulatory framework will be adopted in China, it means the present application of medical technique mode should be reconsidered and adjusted based on the risk analysis. Furthermore, the construction of two-tier regulatory framework which is tailored to meet the demands of development of medical products of tissue engineering and regenerative medicine still remains a challenge.展开更多
文摘In this article,an expansive interpretation of“Tissue Engineering”is proposed which is in congruence with classical and recent published definitions.I further simplify the definition of tissue engineering as:“Exerting systematic control of the body’s cells,matrices and fluids.”As a consequence,many medical therapies not commonly considered tissue engineering are placed in this category because of their effect on the body’s responses.While the progress of tissue engineering strategies is inexorable and generally positive,it has been subject to setbacks as have many important medical therapies.Medical practice is currently undergoing a transition on several fronts(academics,start-up companies,going concerns)from the era of“replacement medicine”where body parts and functions are replaced by mechanical,electrical or chemical therapies to the era of tissue engineering where health is restored by regeneration generation or limitation of the body’s tissues and functions by exploiting our expanding knowledge of the body’s biological processes to produce natural,healthy outcomes.
基金The present study is supported by National Hightech R&D Program of China (2011AA020104)
文摘The current regulatory status in the USA, European Union (EU), Japan, and China, associated with the clinical application of tissue engineering and regenerative medicine is presented. It is found that similar regulatory framework has been constructed in the USA and EU, in which risk-based regulatory strategy is used to determine which regulatory mode is more desirable between medical technique and medical product. Also, it is suggested that two-tier regulatory framework of medical products be constructed, with the first level built on existing and newly introduced regulatory provisions and the second technical level encompassing all the technical requirements. In China, the demarcation line between medical technique mode and medical product mode is not made clear and coherent and flexible regulatory framework has not been intentionally designed. If the recommendations concerning the desirability of regulatory framework will be adopted in China, it means the present application of medical technique mode should be reconsidered and adjusted based on the risk analysis. Furthermore, the construction of two-tier regulatory framework which is tailored to meet the demands of development of medical products of tissue engineering and regenerative medicine still remains a challenge.
