Open AccessExamination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the U.S., and Australia: Part II—A Method of Software Documentary Analysis
Author(s) -
Ilic Nina,
Savic Snezana,
Siegel Evan,
Atkinson Kerry,
Tasic Ljiljana
Publication year - 2012
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.5966/sctm.2012-0038
Subject(s) - terminology , concordance , good manufacturing practice , agency (philosophy) , food and drug administration , regulatory affairs , medicine , business , computer science , pharmacology , microbiology and biotechnology , sociology , biology , social science , philosophy , linguistics
This research (Part II) draws attention to the importance of understanding the complexity of a global regulatory environment applicable to biologic drugs, including stem cells or their progeny. It demonstrates considerable differences in the regulatory approach to biologic drugs' development and application, particularly with respect to terminology and definitions used in regional regulatory frameworks.