Multidisciplinary: cell therapy and tissue engineering
The European Medicines Agency's scientific guidelines on cell therapy and tissue engineering help medicine developers prepare marketing authorisation applications for human medicines.
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
Questions and answers