Abstract
This chapter provides an overview of the current status of cell therapy regulation in Europe. This includes the description of GMP standards and other significant regulations for quality assurance. Accreditation principles and measures will be discussed, and recent regulations on advanced therapy medicinal products which are more than minimally manipulated will be explained.
Keywords
- Medicinal Product
- Good Manufacture Practice
- Investigational Medicinal Product
- Commission Directive
- Advance Therapy Medicinal Product
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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Oancea, G., Wagner, B., Henschler, R. (2012). Cell Therapy Regulations from a European Perspective. In: Allan, D., Strunk, D. (eds) Regenerative Therapy Using Blood-Derived Stem Cells. Stem Cell Biology and Regenerative Medicine. Humana Press. https://doi.org/10.1007/978-1-61779-471-1_14
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DOI: https://doi.org/10.1007/978-1-61779-471-1_14
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