title: Global regulatory registration requirements for collagen-based combination products: points to consider.
abstract: Collagen-based medical products provide an ideal and unique matrix for the delivery of drugs, biologics and other therapeutic agents. Collagen has a long history of safety and effectiveness. Collagen is biodegradable with minimal tissue reaction. Regulatory requirements for approval of collagen-based combination products are changing as more high technology combinations are developed. There are special considerations that need to be addressed for collagen products. Products of animal origin must meet specific requirements in regards to safety factors regarding Transmissable Spongiform Encephalopathies. Global regulatory registration requirements and special controls are presented.
authors: Regulatory Affairs, Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA. jogrady@integra-ls.com
authors: Judith E
authors: JE
authors: O'Grady
authors: Diana M
authors: DM
authors: Bordon
mesh_terms: D020341:Absorbable Implants / Q000592:standards; D000818:Animals; D002417:Cattle; D003094:Collagen / Q000592:standards*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004337:Drug Carriers / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D016643:Encephalopathy, Bovine Spongiform / Q000517:prevention & control; D004864:Equipment and Supplies / Q000592:standards; D006801:Humans
chemical_list: D004337:Drug Carriers; D003094:Collagen