Tag Archive
The following is a list of all entries tagged with Cell therapy:
EMA, the European Drug Regulators, Publish Draft Guidance on Non-Clinical and Clinical Aspects of Medical Products Containing Geneticaly Modified Cells
Filed in biotechnology,clinical,pre-clinical, July 25, 2010, 10:04 amThis guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its focus is on the quality, safety and efficacy requirements of genetically modified cells developed as medicinal products.
EMA, the European Drug Regulator publishes, Draft Guideline on Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.
Filed in biotechnology,clinical,manufacturing,pre-clinical, July 12, 2010, 11:55 amThis guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans. Its focus is on the quality, safety and efficacy requirements of genetically modified cells developed as medicinal products.
Drug Regulators, EMA (EMEA), Publish Reflection Paper on in-vitro Cultured Chondrocyte Containing Products for Cartilage Repair of the Knee
Filed in clinical,pre-clinical, May 30, 2010, 9:35 amThis reflection paper addresses specific points related to medicinal products containing in vitro cultured autologous chondrocytes intended for the repair of cartilage lesions of the knee. This reflection paper is considered to supplement the ‘Guideline on human cell-based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline.
Drug Regulators, EMEA, Publish Guidline on Xenogenic Cell-Based Medicinal Products
Filed in clinical,manufacturing, December 31, 2009, 8:56 amXenogeneic cell-based therapy is the use of viable animal somatic cell preparations, suitably adapted for: (a) implantation/ infusion into a human recipient or (b) extracorporeal treatment through bringing (non-human) animal cells into contact with human body fluids, tissues or organs
Drug Regulatos Publish Draft Reflection Paper on In-vitro Cultured Chondrocyte Containing Products for Cartilage Repair
Filed in formulation,manufacturing,regulatory, November 3, 2009, 5:41 pmThis reflection paper addresses specific points related to products containing autologous chondrocytes intended for the repair of lesion of cartilage of the knee not discussed in the ‘Guideline on human cell based medicinal products’ (EMEA/CHMP/410869/2006) and therefore it should be read in conjunction with the guideline
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