title: [Supervision, administration and standard research related to tissue engineered medical products].
abstract: Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical & Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).
authors.affiliation: National Institute for the Control of Pharmaceutical and Biological Products, Beijing, P. R. China 100050. xitingfei@tom.com
authors.forename: Ting-fei
authors.initials: TF
authors.lastname: Xi
authors.forename: Liang
authors.initials: L
authors.lastname: Chen
authors.forename: Peng
authors.initials: P
authors.lastname: Zhao
mesh_terms: D001688:Biological Products / Q000592:standards*; D018795:Device Approval; D004869:Equipment Safety; D017408:Guidelines as Topic; D006801:Humans; D023822:Tissue Engineering / Q000331:legislation & jurisprudence* / Q000592:standards*
chemical_list: D001688:Biological Products