欧盟监管部门关于基因与细胞治疗产品的相关法规和指导原则汇总-20220325update

欧盟监管部门关于基因与细胞治疗产品的相关法规和指导原则汇总-20220325update

13800

2001.11.06 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
2005.03 Guideline on Development and Manufacture of Lentiviral Vectors
2007.11.13 REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
2008.09 Guideline on human cell-based medicinal products
2008.11 Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products
2009.07 implementing Regulation (EC) No 1394/2007 with regard to the evaluation and certification of quality and non-clinical data relating to ATMPs developed by SMEs.
2010 Gene Transfer Medicinal Products for Human Use 5.14
2010.05 Guideline in follow-up of patients administered with gene therapy medicinal products
2011.12 Reflection paper on design modifications of gene therapy medicinal products during development
2013.04 Reflection paper on management of clinical risks deriving from insertional mutagenesis
2013.12 Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced therapy medicinal products
2016.09 Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer
2018 Consultation document, Good clinical practice for advanced therapy medicinal products
2018.03 Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products
2018.04 Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products(Draft, end of consultation)
2018.05 Guidelines on good manufacturing practice specific to advanced therapy medicinal products
2018.11 Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products
2019.07 Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
2019.08 Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
2020.04 Committee for Advanced Therapies (CAT)
2020.04.28 EMA warns against using unproven cell-based therapies
2021.11.29 Guide on advanced therapy medicinal products-quality flowchart
2021.11.29 Guide on advanced therapy medicinal products – Quality checklist
2021.11.29 Guide on advanced therapy medicinal products – Non-clinical development checklist 
2021.11.29 Guide on advanced therapy medicinal products – Non-clinical development flowchart
2021.11.29 Guide on advanced therapy medicinal products – Clinical development flowchart 
2021.11.29 Guide on advanced therapy medicinal products – Clinical development checklist

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