title: Premarket Regulation of Tissue Engineered Medical Products in China.
abstract: Tissue engineered medical products (TEMPs) use state-of-the-art technologies and offer the patients with alternative clinical options for diseases that conventional treatments may fail or be incompetent. However promising, this technology is comparatively new with very limited hands-on experiences with both manufacturing and clinical therapy. Of great significance to products with such complexity and novelty is the establishment of a complete jurisdiction framework and a standardization database so that the safety of the technique in clinical treatment can be ensured. Although different regulatory routes are adopted in different countries, risks are generally considered to be derived from the cellular components within the product, the material scaffolds, and potentially from the final products. This article is to provide an insight of the regulatory considerations and the role of China Food and Drug Administration (CFDA) in the supervision of TEMPs.
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Chunren
authors.initials: C
authors.lastname: Wang
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Anqi
authors.initials: A
authors.lastname: Wang
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Feng
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Linnan
authors.initials: L
authors.lastname: Ke
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Yuanli
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Qianqian
authors.initials: Q
authors.lastname: Han
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Xue
authors.initials: X
authors.lastname: Sun
authors.affiliation: Division of Biomaterials and Tissue Engineering, National Institutes for Food and Drug Control , Beijing, P.R. China .
authors.forename: Zhaopeng
authors.initials: Z
authors.lastname: Yang
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use; D002681:China; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D023822:Tissue Engineering / Q000331:legislation & jurisprudence / Q000592:standards
chemical_list: D001688:Biological Products