Advanced Therapy Medicinal Products (ATMPs)

August 4, 2014 | by |

2013. Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products. European Medicines Agency. London, UK.

2012. Reflection paper on clinical aspects related to tissue engineered products. European Medicines Agency. London, UK.

2012. Reflection paper on classification of Advanced Therapy Medicinal Products. European Medicines Agency. London, UK.

2011. CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products. European Medicines Agency. London, UK.

2010. Reflection paper on stem cell-based medicinal products. European Medicines Agency. London, UK.

2010. Reflection paper on in-vitro cultured chondrocyte containing products for cartilage repair of the knee. European Medicines Agency. London, UK.

2009. COMMISSION DIRECTIVE 2009/120/EC  amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products. European Medicines Agency. London, UK.

2009. COMMISSION REGULATION (EC) No 668/2009 implementing Regulation (EC) No 1394/2007  Evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises. European Medicines Agency. London, UK.

2007. Draft Guideline on Human Cell-Based Medicinal Products. European Medicines Agency. London, UK.

2007. REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. European Medicines Agency. London, UK.

2006. Draft Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer. European Medicines Agency. London, UK.

2004. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. European Medicines Agency. London, UK.

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