Global regulatory registration requirements for collagen-based combination products: points to consider.
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.
O'Grady
Judith E
JE
Regulatory Affairs, Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA. jogrady@integra-ls.com
Bordon
Diana M
DM
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
D004337:Drug Carriers; D003094:Collagen