Multidisciplinary guidelines: cell therapy and tissue engineering

The European Medicines Agency's scientific guidelines on cell therapy and tissue engineering help medicine developers prepare marketing authorisation

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells
• Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
• Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products
• Human cell-based medicinal products
• Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer
• Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products
• Xenogeneic cell-based medicinal products

Reflection papers

• Clinical aspects related to tissue engineered products
• In-vitro cultured chondrocyte containing products for cartilage repair of the knee
• Stem cell-based medicinal products

Position statements

• Creutzfeldt-Jakob disease and advanced therapy medicinal products

Questions and answers

• Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)
• Development of non-substantially manipulated cell-based advanced therapy medicinal products: flexibility introduced via the application of the risk-based approach

  Reference Number: EMA/CAT/216556/2017