| 简介/内容概述： | This guideline describes the evaluation of the viral safety of biotechnology products including viral clearance and testing, and it outlines what data should be submitted in marketing applications for those products. Biotechnology products include biotherapeutics and certain biological products derived from cell lines of human or animal origin (e.g., mammalian, avian, or insect). In this document, the term virus excludes nonconventional transmissible agents like those associated with mammalian prions (e.g., bovine spongiform encephalopathy, scrapie). Applicants are encouraged to discuss transmissible spongiform encephalopathy associated issues with the appropriate regulatory authorities as they are not in scope of this guideline. |
